Systemic Sclerosis Medications

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	octagam 10 \| Mycil Athlete s Foot Spray \| TRADOREC XL 100 mg 200mg and 300mg prolonged release tablets \| albunorm 20 200g l solution for infusion \| Beechams Veno s Cough Mixture \| Voltarol Pain eze Tablets \| Ceplene 0.5 mg 0.5 ml solution for injection \| Chirocaine 2.5mg ml solution for injection concentrate for solution for infusion \| GONAL f 1050 IU 1.75 ml 77mcg 1.75 ml \| Voltarol Joint Pain 12.5mg Tablets \| Betaloc I.V. Injection \| Flixotide Nebules 0.5mg 2ml \| Lidocaine Hydrochloride Injection BP 1.0 w v \| Cozaar Comp 50 12.5mg 100 12.5mg 100 25mg Film Coated Tablets \| Corsodyl 0.2 Mouthwash \| Premique 0.625mg 5mg Coated Tablets \| Norditropin Simplexx 10mg 1.5ml \| Vitaphil Aide \| Ziagen Solution \| Xibrom \| Thioridazine Concentrate \| Viridal Duo 40 micrograms ml Powder and Solvent for Solution for Injection. \| Vimpat Intravenous \| Selfemra \| Systemic Sclerosis Medications \| Sutent \| Skin and Seborrhea \| SymlinPen 120 \| Short Stature for Age Medications \| Sprycel \| sodium chloride \| Sodium Fluoride F 18 Injection \| Selzentry \| Spironolactone and Hydrochlorothiazide \| Supralip 160mg \| propylthiouracil \| NegGram Suspension \| Iodoshield Active \| Hematogen FA Capsules \| Sumatriptan Nasal Spray \| Plan B \| Polytrim Solution \| Trocaine Throat Lozenges \| NiQuitin 4 mg Mint Gum \| Phospha 250 Neutral \| Milrinone \| Promixin 1 million International Units IU Powder for Solution for Injection \| Leader Allerhist \| pyridoxine \| Mastocytosis Medications

Systemic Sclerosis Medications

Definition of Systemic Sclerosis: A multisystem disorder of unknown aetiology. It is characterised by fibrosis (scarring) of the skin, blood vessels and internal organs. Involvement of the gastrointestinal tract, heart, kidneys and lungs is common.

Drugs associated with Systemic Sclerosis

The following drugs and medications are in some way related to, or used in the treatment of Systemic Sclerosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Systemic Sclerosis

Medical Encyclopedia:

Scleroderma

Harvard Health Guide:

Symptoms and treatment for Scleroderma
Drug List: Cytoxan Cytoxan-Lyophilized-Oral-Injection Deltasone Meticorten Neosar Sterapred Sterapred-Ds Trexall

Alkylating agents

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Alkylating agents are a class of chemotherapy drugs that bind to DNA and prevent proper DNA replication. They have chemical groups that can form permanent covalent bonds with nucleophilic substances in the DNA.

Alkylating agents are used as part of chemotherapy in different types of cancers.

Mental Retardation Medications

There are currently no drugs listed for "Mental Retardation".

Definition of Mental Retardation: Mental retardation is described as below-average general intellectual function with associated deficits in adaptive behavior that occurs before age 18.

Learn more about Mental Retardation

Medical Encyclopedia:

Fragile X syndromeKrabbe diseaseMental retardationPolydactylyPrader-Willi syndromeTrisomy 13Trisomy 18Tuberous sclerosis
Drug List:

Antipsoriatics

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Antipsoriatics are agents that are either taken orally or applied locally on the skin to treat psoriasis. Psoriasis is a chronic skin condition with itchy, dry scaly patches. These agents have different modes of action but in due course they work to control psoriasis.

Systemic Fungal Infection Medications

Drugs associated with Systemic Fungal Infection

The following drugs and medications are in some way related to, or used in the treatment of Systemic Fungal Infection. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Systemic Fungal Infection Aspergillosis (15 drugs in 5 topics) Blastomycosis (9 drugs) Fungal Endocarditis (4 drugs) Fungal Meningitis (21 drugs in 5 topics) Fungal Peritonitis (1 drug) Fungal Pneumonia (2 drugs) Fusariosis (1 drug) Gastrointestinal Candidiasis (15 drugs in 2 topics)
Drug List: Ancobon Vfend

Ampyra

Generic Name: dalfampridine (dal FAM pri deen)
Brand Names: Ampyra

What is dalfampridine?

Dalfampridine is a potassium channel blocker.

Dalfampridine is used to improve walking in patients with multiple sclerosis (MS).

Dalfampridine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dalfampridine? You should not use dalfampridine if you are allergic to it, or if you have moderate to severe kidney disease, if you have ever had a seizure (convulsions), or if you are also taking another multiple sclerosis drug called Fampridine.

Before you take dalfampridine, tell your doctor if you have kidney disease.

Do not take more than 2 tablets in a 24-hour period. Do not use a tablet that has been broken or crushed. A broken tablet can release too much of the drug at one time. This can increase your risk of having a seizure. Stop taking dalfampridine and call your doctor at once if you a seizure, pain or burning when you urinate, problems with your balance, numbness or tingly feeling, or a relapse of your MS symptoms. What should I discuss with my health care provider before taking dalfampridine? You should not use dalfampridine if you are allergic to it, or if you have:

moderate to severe kidney disease;

if you have ever had a seizure (convulsions); or

if you are also taking another MS drug called Fampridine (4-aminopyridine).

To make sure you can safely take dalfampridine, tell your doctor if you have kidney disease.

FDA pregnancy category C. It is not known whether dalfampridine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether dalfampridine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using dalfampridine. Do not give this medication to anyone under 18 years old without the advice of a doctor. How should I take dalfampridine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Dalfampridine is usually taken once every 12 hours. Follow your doctor's instructions.

Do not take more than 2 tablets in a 24-hour period.

Dalfampridine may be taken with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Do not dissolve the tablet in liquid. Breaking or dissolving the pill may cause too much of the drug to be released at one time. Do not use a dalfampridine tablet that has been accidentally crushed or broken. This can increase your risk of having a seizure. Store at room temperature away from moisture and heat.

Throw away any leftover medicine after the expiration date on the label has passed.

See also: Ampyra dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause confusion, problems with thinking or memory, tremors, sweating, or seizures.

What should I avoid while taking dalfampridine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Dalfampridine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking dalfampridine and call your doctor at once if you have a serious side effect such as:

seizure (convulsions);

pain or burning when you urinate;

problems with balance;

numbness, burning pain, or tingly feeling;

relapse or worsening of MS symptoms;

Less serious side effects may include:

headache, dizziness;

sleep problems (insomnia);

nausea, constipation, upset stomach;

weakness;

stuffy nose, sinus pain, sore throat; or

back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect dalfampridine?

There may be other drugs that can interact with dalfampridine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Ampyra resources Ampyra Side Effects (in more detail)Ampyra DosageAmpyra Use in Pregnancy & BreastfeedingAmpyra Drug InteractionsAmpyra Support Group17 Reviews for Ampyra - Add your own review/rating Ampyra Prescribing Information (FDA) Ampyra Monograph (AHFS DI) Ampyra Advanced Consumer (Micromedex) - Includes Dosage Information Ampyra Consumer Overview Ampyra MedFacts Consumer Leaflet (Wolters Kluwer) Dalfampridine Professional Patient Advice (Wolters Kluwer) Compare Ampyra with other medications Multiple Sclerosis Where can I get more information? Your pharmacist can provide more information about dalfampridine.

See also: Ampyra side effects (in more detail)

Glucocorticoids

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Glucocorticoids are one of the corticosteroids (adrenal cortical steroids) released from the adrenal gland. The physiological stimulus for glucocorticoid release is corticortiotropin (adrenocorticotropic hormone) from the anterior pituitary.

Glucocorticoids are synthesized and released as needed and bind to glucocorticoid receptors.

Glucocorticoids e.g. cortisol and cortisone, are essential for the utilization of carbohydrate, fat and protein by the body and for normal response to stress. Naturally occurring and synthetic glucocorticoids have very powerful anti-inflammatory effects and are used to treat conditions that involve inflammation. They also decrease the body

Prednisone

Pronunciation: PRED-ni-sone
Generic Name: Prednisone
Brand Name: Generic only. No brands available.
Prednisone is used for:

Treating severe allergies, arthritis, asthma, multiple sclerosis, and skin conditions. It may also be used for other conditions as determined by your doctor.

Prednisone is a corticosteroid. It works by decreasing or preventing tissues from responding to inflammation. It also modifies the body's response to certain immune stimulation.

Do NOT use Prednisone if: you are allergic to any ingredient in Prednisone you have a systemic fungal infection you are currently taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prednisone:

Some medical conditions may interact with Prednisone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are scheduled for a vaccination with a live virus vaccine (eg, smallpox) if you have an underactive thyroid, liver or kidney problems, diabetes, or ulcerative colitis if you have heart problems, esophagitis, gastritis, stomach obstruction or perforation, or an ulcer if you have a history of mental problems, such as depression if you have a herpes infection in your eye or any other type of infection (bacterial, fungal, or viral); have or recently had tuberculosis (TB) or tested positive for TB, measles, or chickenpox

Some MEDICINES MAY INTERACT with Prednisone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because the effectiveness of Prednisone may be decreased Clarithromycin azole antifungals (eg, ketoconazole), steroidal contraceptives (eg, desogestrel), or troleandomycin because side effects, such as weakness, confusion, muscle aches, joint pain, or low blood sugar, may occur Methotrexate or ritodrine because the actions and side effects of these medicines may be increased Hydantoins (eg, phenytoin), mifepristone, or live vaccines because the effectiveness of these medicines may be decreased Anticoagulants (eg, warfarin) or aspirin because the actions and side effects of these medicines may be increased or decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prednisone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prednisone:

Use Prednisone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prednisone by mouth with food. Prednisone comes as a dose pack with specific instructions as to when to take the medicine or how much to take each time. It is very important to follow these instructions as closely as possible. Do not miss any doses. If you miss a dose of Prednisone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prednisone.

Important safety information: Patients on long-term steroid therapy should carry an ID card at all times that says they take Prednisone. Prednisone makes you more susceptible to illnesses, especially if you take it for an extended period of time. Prevent infection by avoiding contact with people who have colds or other infections. If you are exposed to chickenpox, measles, or TB while taking Prednisone or within 12 months after stopping Prednisone, call your doctor. Report any injuries or signs of an infection (fever, sore throat, pain during urination, or muscle aches) that occur during treatment and within 12 months after stopping Prednisone. Your dose may need to be adjusted or you may need to start taking Prednisone again. Tell your doctor or dentist that you take Prednisone before you receive any medical or dental care, emergency care, or surgery. Prednisone may cause an elevation in blood pressure, salt and water retention, and increased potassium loss. You may need to restrict the use of salt and take a calcium supplement. Prednisone can cause calcium loss and promote the development of osteoporosis. Take adequate calcium and vitamin D supplements. Do not receive a live vaccine, especially smallpox, while you are taking Prednisone. Diabetes patients - Prednisone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests may be performed while you use Prednisone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Infants and CHILDREN on long-term therapy must be closely monitored by a health care provider. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Prednisone. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prednisone while you are pregnant. Prednisone is found in breast milk. If you are or will be breast-feeding while you use Prednisone, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Prednisone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Difficulty sleeping; feeling of a whirling motion; increased appetite; increased sweating; indigestion; mood changes; nervousness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite loss; black, tarry stools; changes in menstrual periods; convulsions; depression; diarrhea; dizziness; exaggerated sense of well-being; fever; general body discomfort; headache; increased pressure in the eye; joint or muscle pain; mood swings; muscle weakness; personality changes; prolonged sore throat, cold, or fever; puffing of the face; severe nausea or vomiting; swelling of feet or legs; unusual weight gain; vomiting material that looks like coffee grounds; weakness; weight loss.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prednisone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prednisone:

Store Prednisone at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prednisone out of the reach of children and away from pets.

General information: If you have any questions about Prednisone, please talk with your doctor, pharmacist, or other health care provider. Prednisone is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prednisone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Prednisone resources Prednisone Side Effects (in more detail) Prednisone Use in Pregnancy & Breastfeeding Drug Images Prednisone Drug Interactions Prednisone Support Group 86 Reviews for Prednisone - Add your own review/rating Compare Prednisone with other medications Acute Lymphocytic Leukemia Adrenocortical Insufficiency Adrenogenital Syndrome Allergic Reactions Ankylosing Spondylitis Aspiration Pneumonia Asthma Atopic Dermatitis Autoimmune Hemolytic Anemia Berylliosis Bullous Pemphigoid Bursitis Chorioretinitis Cluster Headaches Cogan's Syndrome Conjunctivitis, Allergic Corneal Ulcer Dermatitis Herpetiformis Dermatomyositis Eczema Epicondylitis, Tennis Elbow Erythroblastopenia Fibromyalgia Gouty Arthritis Graft-versus-host disease Hay Fever Herpes Zoster Herpes Zoster Iridocyclitis Hypercalcemia of Malignancy Idiopathic Thrombocytopenic Purpura Immunosuppression Inflammatory Bowel Disease Inflammatory Conditions Iridocyclitis Iritis Juvenile Rheumatoid Arthritis Keratitis Leukemia Lichen Planus Lichen Sclerosus Loeffler's Syndrome Lymphoma Multiple Sclerosis Mycosis Fungoides Nephrotic Syndrome Neurosarcoidosis Osteoarthritis Pemphigoid Pemphigus Pharyngitis Polymyositis/Dermatomyositis Psoriasis Psoriatic Arthritis Rheumatoid Arthritis Sarcoidosis Seborrheic Dermatitis Sinusitis Skin Rash Synovitis Systemic Lupus Erythematosus Systemic Sclerosis Thrombocytopenia Toxic Epidermal Necrolysis Tuberculosis, Extrapulmonary Tuberculous Meningitis Ulcerative Colitis Uveitis, Posterior

Prednisone Concentrate

Pronunciation: PRED-ni-sone
Generic Name: Prednisone
Brand Name: Generics only. No brands available.
Prednisone Concentrate is used for:

Treating severe allergies, arthritis, asthma, multiple sclerosis, and skin conditions. It may also be used for other conditions as determined by your doctor.

Prednisone Concentrate is a corticosteroid. It works by decreasing or preventing tissues from responding to inflammation. It also modifies the body's response to certain immune stimulation.

Do NOT use Prednisone Concentrate if: you are allergic to any ingredient in Prednisone Concentrate you have a systemic fungal infection you are currently taking mifepristone or disulfiram

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prednisone Concentrate:

Some medical conditions may interact with Prednisone Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Prednisone Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because the effectiveness of Prednisone Concentrate may be decreased Clarithromycin, azole antifungals (eg, ketoconazole), steroidal contraceptives (eg, desogestrel), or troleandomycin because side effects, such as weakness, confusion, muscle aches, joint pain, or low blood sugar, may occur Methotrexate or ritodrine because the actions and side effects of these medicines may be increased Hydantoins (eg, phenytoin), mifepristone, or live vaccines because the effectiveness of these medicines may be decreased Anticoagulants (eg, warfarin) or aspirin because the actions and side effects of these medicines may be increased or decreased Certain cephalosporins (eg, cefotetan), disulfiram, fluorouracil, furazolidone, metronidazole and derivatives (eg, tinidazole), or sulfonylureas (eg, glipizide) because risk of side effects, such as flushing, headache, fast or irregular heartbeat, nausea, or vomiting, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prednisone Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prednisone Concentrate:

Use Prednisone Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prednisone Concentrate by mouth with food. Use the dropper that comes with Prednisone Concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Prednisone Concentrate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prednisone Concentrate.

Important safety information: Patients on long-term steroid therapy should carry an ID card at all times that says they are taking Prednisone Concentrate. Prednisone Concentrate makes you more susceptible to illnesses, especially if you take it for an extended period of time. Prevent infection by avoiding contact with people who have colds or other infections. If you are exposed to chickenpox, measles, or TB while taking Prednisone Concentrate or within 12 months after stopping Prednisone Concentrate, call your doctor. Report any injuries or signs of an infection (fever, sore throat, pain during urination, or muscle aches) that occur during treatment and within 12 months after stopping Prednisone Concentrate. Your dose may need to be adjusted or you may need to start taking Prednisone Concentrate again. Tell your doctor or dentist that you take Prednisone Concentrate before you receive any medical or dental care, emergency care, or surgery. Long-term use may cause cataracts, glaucoma, and eye infections. Prednisone Concentrate may cause an elevation in blood pressure, salt and water retention, and increased potassium loss. You may need to restrict the use of salt and take a calcium supplement. Prednisone Concentrate can cause calcium loss and promote the development of osteoporosis. Take adequate calcium and vitamin D supplements. If you are taking Prednisone Concentrate for a long period of time, do not suddenly stop taking it without checking with your doctor. Do not receive a live vaccine, especially smallpox, while you are taking Prednisone Concentrate. Talk with your doctor before you receive any vaccine. Diabetes patients - Prednisone Concentrate may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests may be performed while you use Prednisone Concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Infants and CHILDREN on long-term therapy must be closely monitored by a health care provider. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Prednisone Concentrate. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prednisone Concentrate while you are pregnant. Prednisone Concentrate is found in breast milk. If you are or will be breast-feeding while you use Prednisone Concentrate, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Prednisone Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Difficulty sleeping; feeling of a whirling motion; increased appetite; increased sweating; indigestion; mood changes; nervousness.

Seek medical attention right away if any of these SEVERE side effects occur:

See also: Prednisone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prednisone Concentrate:

Store Prednisone Concentrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prednisone Concentrate out of the reach of children and away from pets.

General information: If you have any questions about Prednisone Concentrate, please talk with your doctor, pharmacist, or other health care provider. Prednisone Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prednisone Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

interferon beta-1b

Generic Name: interferon beta-1b (in ter FEAR on BAY ta 1b)
Brand Names: Betaseron, Extavia

What is interferon beta-1b?

Interferon beta-1b is made from human proteins. Interferons help the body fight viral infections.

Interferon beta-1b is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Interferon beta-1b may also be used for other purposes other than those listed in this medication guide.

What is the most important information I should know about interferon beta-1b? This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1b if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using interferon beta-1b, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, a bleeding or blood-clotting disorder, anemia (low red blood cells), or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1b if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Interferon beta-1b is given as an injection under the skin, usually at bedtime every 48 hours (2 days). You may be given instructions on how to use your injections at home. You may be shown how to inject your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before using interferon beta-1b? Do not use this medication if you are allergic to interferons or human albumin. Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1b if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

liver disease;

a thyroid disorder;

epilepsy or other seizure disorder;

a bleeding or blood-clotting disorder, such as hemophilia;

anemia (lack of red blood cells); or

a history of depression or suicidal behavior.

FDA pregnancy category C. This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1b if you are pregnant. Tell your doctor if you become pregnant during treatment. It is not known whether interferon beta-1b passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Interferon beta-1b is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use interferon beta-1b?

Interferon beta-1b is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Interferon beta-1b is injected into a skin area of the thigh, stomach, buttocks, or back of the upper arm. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Interferon beta-1b is usually given as one injection at bedtime every 48 hours (2 days). Follow the directions on your prescription label. Try to use your injections at the same time each dosing day.

Interferon beta-1b is a powder that comes in a single-use vial (bottle) with a liquid (diluent) that must be mixed with the powder in the vial. Gently swirl but do not shake the vial after mixing the medicine. Allow any bubbles or foam to settle before drawing the medicine into a syringe.

If the medicine has changed colors or has any particles in it, call your doctor for a new prescription.

Do not draw your interferon beta-1b dose into a syringe until you are ready to give yourself an injection. Use a different place on your skin each time you inject this medication. Do not inject interferon beta-1b into the same skin area two times in a row.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Store interferon beta-1b vials at room temperature away from moisture and heat. After mixing the medicine you should use it right away, or within 3 hours after mixing if you store it in a refrigerator. Do not freeze. What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. Then wait at least 48 hours before using another injection, and restart your dosing schedule at that time. Do not use more than one injection every 48 hours (2 days).

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an interferon beta-1b overdose are not known. What should I avoid while using interferon beta-1b?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using interferon beta-1b.

Interferons can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Interferon beta-1b side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using interferon beta-1b and call your doctor at once if you have any of these serious side effects:

depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;

bruising, swelling, oozing, or skin changes where the injection was given;

weight changes, pounding heartbeats, feeling too hot or cold;

fever, chills, body aches, flu symptoms; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

weakness;

headache;

muscle pain or weakness;

sleep problems (insomnia);

stomach pain;

swelling in your hands or feet;

skin rash; or

irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Interferon beta-1b Dosing Information

Usual Adult Dose for Multiple Sclerosis:

Initial: 0.0625 mg subcutaneously every other day, and increased (by 25% increments) every 2 weeks, over a 6 week period, to maintenance dose
Maintenance: 0.25 mg subcutaneously every other day

Usual Adult Dose for Colorectal Cancer:

Phase II trials - advanced colorectal carcinoma (n=81)
9 million international units subcutaneously on days 1, 3, and 5, thereafter 3 times a week (in combination with fluorouracil)

Usual Pediatric Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy:

Case (n=1)
1.5 million international units subcutaneously twice a week for 1 week, then 3 million international units 3 times a week

Usual Pediatric Dose for Multiple Sclerosis:

Study (n=1)
Greater than 8.5 years: 8 million international units (0.25 mg) subcutaneously every other day

What other drugs will affect interferon beta-1b?

There may be other drugs that can affect interferon beta-1b. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More interferon beta-1b resources Interferon beta-1b Side Effects (in more detail) Interferon beta-1b Use in Pregnancy & Breastfeeding Interferon beta-1b Drug Interactions Interferon beta-1b Support Group 2 Reviews for Interferon beta-1b - Add your own review/rating interferon beta-1b Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Interferon Beta-1b Professional Patient Advice (Wolters Kluwer) Interferon Beta-1b Solution MedFacts Consumer Leaflet (Wolters Kluwer) Betaseron Prescribing Information (FDA) Betaseron Consumer Overview Extavia Prescribing Information (FDA) Extavia Consumer Overview Compare interferon beta-1b with other medications Chronic Inflammatory Demyelinating Polyradiculoneuropathy Colorectal Cancer Multiple Sclerosis Where can I get more information? Your pharmacist can provide more information about interferon beta-1b.

See also: interferon beta-1b side effects (in more detail)

Novantrone

Generic Name: Mitoxantrone (mye-toe-ZAN-trone)
Brand Name: Novantrone

Novantrone may cause severe blood disorders, such as bone marrow suppression (which decreases your body's ability to fight infection), or cause you bruise or bleed easily. Tell your doctor if you experience fever, chills, sore throat, or unusual bruising or bleeding. Novantrone may cause severe and life-threatening heart problems. Heart problems may occur during therapy or sometimes months to years after receiving Novantrone, and may occur even if you do not have any risk factors. Risk may increase with higher doses of Novantrone. Before using Novantrone, tell your doctor if you have a history of heart problems, radiation therapy, or treatment with anthracyclines (eg, doxorubicin), other similar medicines, or medicines that may cause heart problems. Talk to your doctor if you are unsure if any of your medicines may cause heart problems. Tell your doctor if you experience swelling of the hands or feet, shortness of breath, or sudden weight gain.

Complete blood counts and heart function tests may be performed to monitor for side effects.

Rarely, treatment with Novantrone may result in the development of a secondary cancer. Your risk may be increased if you are taking certain other cytotoxic medicines. Tell your doctor if you have a history of taking cytotoxic medicines.

Novantrone is used for:

Reducing disability and the number of relapses in certain patients with multiple sclerosis. It is used along with other medicine(s) to treat acute nonlymphotcytic leukemia or advanced prostate cancer in certain patients. It may also be used for other conditions as determined by your doctor.

Novantrone is an antineoplastic agent. How it works is not fully understood. It is thought to interfere with cell reproduction and growth, which helps reduce the number of cancer cells in the body.

Do NOT use Novantrone if: you are allergic to any ingredient in Novantrone you have multiple sclerosis along with certain heart problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Novantrone:

Some medical conditions may interact with Novantrone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have chickenpox, herpes, bone marrow depression, liver problems, heart problems, or gout if you have previously received chemotherapy or have received radiation therapy in the chest area

Some MEDICINES MAY INTERACT with Novantrone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cyclosporine because the risk of Novantrone's side effects may be increased Digoxin or hydantoins (eg, phenytoin) because their effectiveness may be decreased by Novantrone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Novantrone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Novantrone:

Use Novantrone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Novantrone is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Novantrone at home, carefully follow the injection procedures taught to you by your health care provider. If Novantrone contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it. Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal. If you miss a dose of Novantrone, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Novantrone.

Important safety information: Novantrone will turn your urine a blue-green color. It may also cause the whites of your eyes to turn a bluish color. This is normal and not a cause for concern. Novantrone may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills. Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Novantrone. Vaccinations may be less effective. Novantrone may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor. Some patients using Novantrone have developed a type of leukemia. Discuss any questions or concerns with your doctor. Lab tests, including complete blood cell counts, liver function tests, blood chemistry, pregnancy tests, uric acid levels, and heart function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. Novantrone is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: Novantrone has been shown to cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Novantrone during pregnancy. It is unknown if Novantrone is excreted in breast milk. Do not breast-feed while taking Novantrone. Possible side effects of Novantrone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; blue-green urine; bluish-colored whites of the eyes; constipation; cough; diarrhea; hair loss or thinning; loss of appetite; loss of menstrual period; menstrual changes; mouth pain; nausea; stomach pain or upset; stuffy nose; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark, pink, or bloody urine; fast or irregular heartbeat; fever, chills, sore throat, or persistent cough; increased, decreased, or painful urination; mental or mood changes (eg, anxiety, depression); mouth sores, inflammation, or severe pain; pain, swelling, or redness at the injection site; severe or persistent tiredness or weakness; shortness of breath; sinus infection; sudden, unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; vision changes.

See also: Novantrone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Novantrone:

Novantrone is usually handled and stored by a health care provider. If you are using Novantrone at home, store Novantrone as directed by your pharmacist or health care provider. Keep Novantrone out of the reach of children and away from pets.

General information: If you have any questions about Novantrone, please talk with your doctor, pharmacist, or other health care provider. Novantrone is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Novantrone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Novantrone resources Novantrone Side Effects (in more detail) Novantrone Use in Pregnancy & Breastfeeding Novantrone Drug Interactions Novantrone Support Group 1 Review for Novantrone - Add your own review/rating Compare Novantrone with other medications Acute Nonlymphocytic Leukemia Multiple Sclerosis Non-Hodgkin's Lymphoma Prostate Cancer

Talc

Class: Sclerosing Agents
CAS Number: 14807-96-6
Brands: Sclerosol

Introduction

Sclerosing agent;1 2 sterile, asbestos- and brucite-free, controlled-granule-size talc powder.1

Uses for Talc Pleural Effusions

Sclerosis of pleural serosal surfaces (pleurodesis) to decrease the risk of malignant pleural effusion recurrence in symptomatic patients with advanced stages of metastatic tumors.1 2 3 4 5 6 7 8 9 10

Safety and efficacy based on data from published literature.1 2 3 14

Absence of reaccumulation of the effusion (determined by clinical examination or chest radiograph) reported in about 93% of patients with recurrent, symptomatic malignant pleural effusions.3 14

Similar success rates with talc slurry or aerosol powder.3

May be at least as effective as intrapleural bleomycin,1 2 6 7 8 9 15 16 17 doxycycline,12 mustine,2 11 or tetracycline2 10 (no longer commercially available as a parenteral formulation in the US) and more effective than therapeutic thoracentesis.1 2 4 11

Talc Dosage and Administration Administration

Administer intrapleurally as a slurry instilled via a chest tube1 or by aerosol during thoracoscopy or open thoracotomy.2

Intrapleural Instillation via Chest Tube Preparation of Slurry

Prepare slurry in a laminar flow hood using aseptic technique.1

Attach 16-gauge needle to a 60-mL Leur-Lok syringe and draw up 50 mL of 0.9% sodium chloride injection into the syringe.1

Vent vial containing 5 g of talc with a needle; slowly inject syringe contents into the vial and swirl to disperse.1

Continue swirling vial to prevent settling; draw up 25 mL of slurry into each of 2 60-mL syringes.1

Draw up sufficient 0.9% sodium chloride injection into each syringe to total 50 mL; each syringe will contain a slurry of 2.5 g of talc per 50 mL of 0.9% sodium chloride injection.1

Draw air into each syringe to the 60-mL mark to provide 10 mL of space for mixing prior to administration.1

Appropriately label each syringe, including expiration date and time, identity of patient to receive the preparation, and the cautionary statements “For Pleurodesis Only–NOT FOR IV ADMINISTRATION” and “Shake Well Before Use.“ 1

Use slurry within 12 hours of preparation.1

Administration Procedure

Prior to administration, adequately drain the effusion from the pleural cavity.1 2 Success of treatment apparently is related to the completeness of pleural fluid drainage and to full reexpansion of the lung.1 2

Completely and continuously agitate the slurry-containing syringes to disperse and avoid settlement of the talc.1

Immediately prior to administration, vent the 10 mL of air (provided for mixing) from each syringe.1

Attach the adapter and place a syringe tip on the adapter; maintain continuous agitation of the syringes.1

Apply gentle pressure to syringe plunger to empty syringe contents through the chest tube into the chest cavity.1

Flush the chest tube with 10–25 mL of 0.9% sodium chloride solution to ensure complete dose delivery; clamp the drainage tube.1

Have the patient move from supine to alternating decubitus positions at 20- to 30-minute intervals over a period of about 2 hours to distribute the talc within the chest cavity;1 however, recent evidence suggests that this step may not be necessary.1

At the end of this period, unclamp the chest drainage tube and remove excess saline by routine continual external suction on the tube.1

Intrapleural Aerosol Administration Procedure

Shake aerosol canister well before use; securely attach actuator button with delivery tube (15 or 25 cm) to canister valve stem.2

Insert delivery tube through the pleural trocar; avoid placing the distal end of the tube adjacent to lung parenchyma or directly against the chest wall.2

For optimal distribution, always maintain canister in an upright position.2

Firmly hold the delivery tube and pleural trocar together in one hand, and gently press the actuator button on the canister.2

While pointing the distal end of the delivery tube in several different directions, administer short bursts to distribute talc equally and extensively on all visceral and parietal pleural surfaces.2

Discard the canister and delivery tube after application.2

The duration of chest tube drainage following sclerosis is dictated by the clinical situation.2

Rate of Administration

Commercially available spray canister delivers talc at a rate of 0.4 g per second but is not considered to be a metered-dose delivery system; dose delivered depends on the extent and duration of manual compression of the actuator button.2

Dosage Adults Pleural Effusions Intrapleural Instillation

5 g as slurry dispersed in 50–100 mL of 0.9% sodium chloride injection.1

Optimal dose is unknown; 5 g was most frequently reported dose in published literature.1

Intrapleural Aerosol

Usually 4–8 g (from 1–2 spray canisters) as a single dose.2

Special Populations

No special population dosage recommendations at this time.1 2

Cautions for Talc Contraindications

No known contraindications.1 2

Warnings/Precautions General Precautions Future Procedures

Prior to administration, consider the possible need for future diagnostic and therapeutic procedures involving the hemithorax.1 2 Sclerosis of pleural space may preclude subsequent diagnostic procedures of the pleura on the treated side and may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes.1 2

Potentially Curable Malignancies

Talc has no known antineoplastic activity; do not use alone for potentially curable malignancies (e.g., a malignant effusion secondary to a potentially curable lymphoma) when systemic antineoplastic therapy would be more appropriate.1 2

Pulmonary Complications

Acute pneumonitis and ARDS reported; 3 of 4 reports of ARDS occurred following relatively large dose (10 g) instilled intrapleurally via chest tube.1 2

IV administration causes pulmonary hypertension and lung parenchymal disease; not reported following intrapleural administration.2

Inhaled talc associated with pulmonary diseases (e.g., silicosis or asbestos-like disease, chronic bronchitis, bronchogenic carcinoma, pleural plaques).2

Aerosol Canister Pressure

The contents of the aerosol canister are under pressure; do not puncture or use near heat or open flame.2

Specific Populations Pregnancy

Category B.1 2

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 2

Geriatric Use

Safety and efficacy in geriatric patients not specifically evaluated.1 2

Estimated mean and median ages of patients receiving intrapleural talc slurry in clinical studies were 60 and 62 years, respectively.1 Mean and median ages of patients receiving talc intrapleural aerosol were 50–62 years.2

Common Adverse Effects

Fever, pain.1 2

Interactions for Talc Specific Drugs

Drug

Comments

Sclerosing agents

Unknown whether talc’s absorptive properties may diminish the effectiveness of subsequent therapy with a second sclerosing agent1 2

Talc Pharmacokinetics Absorption Bioavailability

Extent of absorption after intrapleural administration not determined; integrity of the pleural surface may affect systemic exposure.1 2

Special Populations

Systemic exposure may be increased when administered immediately following lung resection or biopsy.1 2

Stability Storage Intrapleural Powder

18–25°C.1 Protect from sunlight.1

Use slurry within 12 hours following preparation.1

Aerosol

15–30°C.2 Do not expose to temperatures >49°C (canister may rupture).2 Avoid freezing.2 Protect from sunlight.2

ActionsActions

Following intrapleural administration, talc induces inflammation that results in fibrosis and adherence of visceral to parietal pleura (pleurodesis), thereby obliterating the pleural space and reducing the chance of fluid reaccumulation.1 2 18 19 20

Advice to Patients

Importance of describing the intrapleural procedure to patients prior to administration of talc.

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Talc

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Intrapleural

Aerosol

4 g

Sclerosol Intrapleural Aerosol (with dichlorodifluoromethane [CFC-12] propellants)

Bryan

Powder

5 g

Sterile Talc Powder

Bryan

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bryan Corporation. Sterile talc powder prescribing information. Woburn, MA; undated.

2. Bryan Corporation. Sclerosol (sterile talc powder) intrapleural aerosol prescribing information. Woburn, MA; undated.

3. American Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000; 162:1987-2001. [PubMed 11069845]

4. Sorensen PG, Svendsen TL, Enk B. Treatment of malignant pleural effusion with drainage, with and without instillation of talc. Eur J Respir Dis. 1984; 65:131-5. [PubMed 6365578]

5. Aelony Y, King R, Boutin C. Thoracoscopic talc poudrage pleurodesis for chronic recurrent pleural effusions. Ann Intern Med. 1991; 115:778-82. [IDIS 288492] [PubMed 1929026]

6. Hamed H, Fentiman IS, Chaudary MA et al. Comparison of intracavitary bleomycin and talc for control of pleural effusions secondary to carcinoma of the breast. Br J Surg. 1989; 76:1266-7. [PubMed 2481558]

7. Ong KC, Indumathi V, Raghuram J et.al. A comparative study of pleurodesis using talc slurry and bleomycin in the management of malignant pleural effusions. Respirology. 2000; 5:99-103. [PubMed 10894097]

8. Zimmer PW, Hill M, Casey K et al. Prospective randomized trial of talc slurry vs bleomycin in pleurodesis for symptomatic malignant pleural effusions. Chest. 1997; 112:430-4. [IDIS 392697] [PubMed 9266880]

9. Noppen M, Degreve J, Mignolet M et al. A prospective, randomised study comparing the efficacy of talc slurry and bleomycin in the treatment of malignant pleural effusions. Acta Clin Belg. 1997; 52:258-62. [PubMed 9489119]

10. Fentiman IS, Rubens RD, Hayward JL. A comparison of intracavitary talc and tetracycline for the control of pleural effusions secondary to breast cancer. Eur J Cancer Clin Oncol. 1986; 22:1079-81. [PubMed 3536525]

11. Fentiman IS, Rubens RD, Hayward JL. Control of pleural effusions in patients with breast cancer. A randomized trial. Cancer. 1983; 52:737-9. [IDIS 173650] [PubMed 6190551]

12. Kuzdzal J, Sladek K, Wasowski D et al. Talc powder vs doxycycline in the control of malignant pleural effusion: a prospective, randomized trial. Med Sci Monit. 2003; 9:PI72-9. [PubMed 12824959]

13. Yim AP, Chan AT, Lee TW et al. Thoracoscopic talc insufflation versus talc slurry for symptomatic malignant pleural effusion. Ann Thorac Surg. 1996; 62:1655-8. [IDIS 377654] [PubMed 8957368]

14. Walker-Renard PB, Vaughan LM, Sahn SA. Chemical pleurodesis for malignant pleural effusions. Ann Intern Med. 1994; 120:56-64. [IDIS 323067] [PubMed 8250457]

15. Noppen M, Degreve J, Mignolet M et al. A prospective, randomised study comparing the efficacy of talc slurry and bleomycin in the treatment of malignant pleural effusions. Acta Clin Belg. 1997; 52:258-62. [PubMed 9489119]

16. Zimmer PW, Hill M, Casey K et al. Prospective randomized trial of talc slurry vs bleomycin in pleurodesis for symptomatic malignant pleural effusions. Chest. 1997; 112:430-4. [IDIS 392697] [PubMed 9266880]

17. Hamed H, Fentiman IS, Chaudary MA et al. Comparison of intracavitary bleomycin and talc for control of pleural effusions secondary to carcinoma of the breast. Br J Surg. 1989; 76:1266-7. [PubMed 2481558]

18. Ruckdeschel JC. Management of malignant pleural effusion: an overview. Semin Oncol. 1988; 15(Suppl 3):24-8. [PubMed 3293215]

19. Andrews CO, Gora ML. Pleural effusions: pathophysiology and management. Ann Pharmacother. 1994; 28:894-903. [IDIS 334463] [PubMed 7524816]

20. Hausheer FH, Yarbro JW. Diagnosis and treatment of malignant pleural effusion. Semin Oncol. 1985; 12:54-75. [PubMed 2579439]

More Talc resources Talc Side Effects (in more detail) Talc Support Group 0 Reviews · Be the first to review/rate this drug

fingolimod

Generic Name: fingolimod (fin GOE li mod)
Brand Names: Gilenya

What is fingolimod?

Fingolimod is an immunosuppressant. It works by keeping immune cells trapped in your lymph nodes so they can't reach the central nervous system (brain and spinal cord).

Fingolimod is used to treat relapsing multiple sclerosis (MS) in adults. This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Fingolimod may also be used for purposes not listed in this medication guide.

What is the most important information I should know about fingolimod?

Before you take fingolimod, tell your doctor if you have an infection, a very slow heart rate, low blood pressure or a history of fainting, high blood pressure, diabetes, liver or kidney disease, asthma or other breathing disorder, congestive heart failure, heart rhythm disorder, a serious heart condition, or if you have ever had an eye condition called uveitis.

Also tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking fingolimod.

You will receive your first dose of fingolimod in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects. Your heart rate will be constantly monitored for at least 6 hours after your first dose of fingolimod. To be sure this medication is not causing harmful effects, your blood cells, blood pressure, liver function, and lung function will need to be tested often. You may also need to eye exams. Fingolimod can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood tests or eye exams.

Tell your doctor if you use any heart or blood pressure medications. Do not receive a "live" vaccine while using fingolimod.

Do not stop taking fingolimod without first talking to your doctor. Stopping suddenly may make your condition worse. If you stop taking fingolimod for 2 weeks or longer, do not start taking it again without asking your doctor. You will need to restart the medication in a hospital setting under observation. What should I discuss with my healthcare provider before taking fingolimod? You should not use fingolimod if you are allergic to it.

Before you take fingolimod, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking fingolimod.

To make sure you can safely take fingolimod, tell your doctor if you have any of these other conditions:

an active or chronic infection;

a very slow heart rate (fewer than 55 beats per minute);

low blood pressure or a history of fainting;

high blood pressure, heart disease, congestive heart failure;

a serious heart condition such as "sick sinus syndrome," second-degree heart block or "AV block";

a history of "Long QT syndrome";

diabetes;

liver or kidney disease;

asthma or other breathing disorder; or

history of an eye condition called uveitis.

FDA pregnancy category C. It is not known whether fingolimod will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Use effective birth control while you are using this medication and for at least 2 months after your treatment ends. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of fingolimod on the baby. Fingolimod can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using fingolimod. Do not give this medication to anyone under 18 years old without medical advice. How should I take fingolimod?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Before you start taking fingolimod, your blood will need to be tested. Your heart function will also need to be checked using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

You may take fingolimod with or without food.

Fingolimod can increase you risk of infection for up to 2 months after you stop taking the medicine. Call your doctor if you develop any signs of a new infection.

To be sure this medication is not causing harmful effects, your blood cells, blood pressure, liver function, and lung function will need to be tested often. You may also need to eye exams. Fingolimod can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood tests or eye exams. Do not stop taking this medication without first talking to your doctor. Stopping suddenly may make your condition worse.

If you stop taking fingolimod for 2 weeks or longer, do not start taking it again without asking your doctor. You will need to restart the medication in a hospital setting under observation.

Store in original package at room temperature away from moisture and heat.

See also: Fingolimod dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest tightness.

What should I avoid while taking fingolimod? Do not receive a "live" vaccine while using fingolimod. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Gu?rin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine. Fingolimod side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

slow heart rate, dizziness, feeling very weak or tired;

chest pain, pounding heartbeats or fluttering in your chest;

sudden numbness or weakness, severe headache, problems with speech or walking;

wheezing, chest tightness, trouble breathing, cough with yellow or green mucus;

fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;

swelling, warmth, redness, oozing, itchy rash, or other signs of skin infection;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

vision problems, blurred vision, eye pain, increased sensitivity to light, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking fingolimod).

Less serious side effects may include:

headache, tired feeling;

back pain;

diarrhea; or

stuffy nose, sinus pain, or cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fingolimod Dosing Information

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 0.5 mg orally once daily.

What other drugs will affect fingolimod?

Tell your doctor if you use any heart or blood pressure medications, such as:

a heart rhythm medication such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), ibutilide (Corvert), or sotalol (Betapace)

a heart rhythm medication such as quinidine (Quin-G), procainamide (Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others;

a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

a calcium channel blocker such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

Tell your doctor about all other medicines you use, especially:

ketoconazole (Nizoral); or

drugs that weaken the immune system, such as cancer medicine, steroids, medicines to prevent rejection of a transplanted organ, and other drugs to treat MS.

This list is not complete and other drugs may interact with fingolimod. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More fingolimod resources Fingolimod Side Effects (in more detail) Fingolimod Dosage Fingolimod Use in Pregnancy & Breastfeeding Fingolimod Drug Interactions Fingolimod Support Group 16 Reviews for Fingolimod - Add your own review/rating fingolimod Advanced Consumer (Micromedex) - Includes Dosage Information Fingolimod MedFacts Consumer Leaflet (Wolters Kluwer) Fingolimod Hydrochloride Monograph (AHFS DI) Gilenya Prescribing Information (FDA) Gilenya Consumer Overview Compare fingolimod with other medications Multiple Sclerosis Where can I get more information? Your pharmacist can provide more information about fingolimod.

See also: fingolimod side effects (in more detail)

Sclerosol

sterile talc
Dosage Form: Powder

Prescribing Information

For Intrapleural Administration Only

Shake Well Immediately Before Using

Sclerosol Description

Sclerosol® Intrapleural Aerosol (sterile talc powder 4 g) is a sclerosing agent for intrapleural administration supplied as a single-use, pressurized spray canister with two delivery tubes of 15 cm and 25 cm in length. Each canister contains 4.0 g of talc, either white or off-white to light grey, asbestos-free, and brucite-free grade of talc of controlled granulometry. The composition of the talc is ? 95% talc as hydrated magnesium silicate. The empirical formula is Mg3 Si4 O10 (OH)2 with molecular weight of 379.3. Associated naturally occurring minerals include chlorite (hydrated aluminum and magnesium silicate), dolomite (calcium and magnesium carbonite), calcite (calcium carbonate) and quartz. Talc is practically insoluble in water, and in dilute solutions of acids and alkali hydroxides. The canister and delivery tubes have been sterilized by gamma irradiation. The aerosol propellant contained in Sclerosol® Intrapleural Aerosol is dichlorodifluoromethane (CFC-12) with 26 g present per canister. The canister delivers 0.4 g of talc per second through the valve and the product contains no other excipients.

Sclerosol - Clinical Pharmacology Mechanism of Action:

The therapeutic action of talc instilled into the pleural cavity is believed to result from induction of an inflammatory reaction. This reaction promotes adherence of the visceral to the parietal pleura, obliterating the pleural space and preventing reaccumulation of pleural fluid. The extent of talc systemically absorbed after intrapleural administration has not been adequately studied. Systemic exposure could be affected by the integrity of the visceral pleura, and therefore could be increased if talc is administered immediately following lung resection or biopsy.

Clinical Studies

The data demonstrating safety and efficacy of talc in the treatment of malignant pleural effusions are derived from the published medical literature. The following four trials were prospective, randomized studies of talc vs. a concurrent control, and provide sufficient detail for evaluation, including a clear, readily determined definition of response (no fluid reaccumulation by chest roentgenogram at one month or greater) and information allowing an analysis of all patients randomized. Talc was statistically significantly superior to the control arms in evaluable patients across the studies.

REFERENCE TREATMENT TUMOR RESPONSE RATE IN
EVALUABLE PTS
p value: Fisher's Exact* RESPONSE RATE IN
ALL PATIENTS
p value: Fisher's Exact* MINIMUM
DURATION OF
RESPONSE

*p values are two-sided

Sorenson et al.
Eur J Respir Dis.
1984; 65:131 Talc slurry
vs
Chest tube drainage Variety 100% (9/9)
vs
58% (7/12)
p=0.022 64% (9/14)
vs
41% (7/17)
p=0.285 3 months Fentiman et al .
Eur J Cancer Clin
Oncol 1986;
22:1079 Talc poudrage
vs
Tetracycline solution Breast 92% (11/12)
vs
48% (10/21)
p=0.022 61% (11/18)
vs
43% (10/23)
p=0.345 12 months Fentiman et al .
Cancer 1983;
52:737 Talc poudrage
vs
Mustine solution Breast 90% (18/20)
vs
53% (9/17)
p=0.023 78% (18/23)
vs
39% (9/23)
p=0.016 6 months Hamed et al .
Br. J. Surg
1989; 76:1266 Talc poudrage
vs
Bleomycin solution Breast 100% (10/10 procedures)
vs
33% (5/15 procedures)
p=0.001 (unclear; results reported as procedures, not patients) ?1 months

In other studies, greater than 1000 patients with malignant pleural effusions have been reported (with varying degrees of detail and durations of response) to have had successful pleurodesis with talc.

Indications and Usage for Sclerosol

Sclerosol® Intrapleural Aerosol, administered by aerosol during thoracoscopy or open thoracotomy, is indicated to prevent recurrence of malignant pleural effusions in symptomatic patients.

Contraindications

None known.

Warnings

None.

Precautions General:

1)Future procedures. The possibility of future diagnostic and therapeutic procedures involving the hemithorax to be treated must be considered prior to administering Sclerosol® Intrapleural Aerosol. Sclerosis of the pleural space may preclude subsequent diagnostic procedures of the pleura on the treated side. Talc sclerosis may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes.

2)Use in potentially curable disease. Talc has no known antineoplastic activity and should not be used for potentially curable malignancies where systemic therapy would be more appropriate, e.g., a malignant effusion secondary to a potentially curable lymphoma.

3)Potential pulmonary complications. Acute pneumonitis or acute respiratory distress syndrome (ARDS) have rarely been reported in association with intrapleural talc administration. Whether these were causally related to talc is unclear. In none of the reported cases was talc applied thoracoscopically or by insufflation. Three of four case reports of ARDS have occurred after treatment with 10 g of talc administered via intrapleural chest tube instillation. One patient died one month post treatment and two patients recovered without further sequelae.

Intravenous administration of talc is a well-recognized cause of pulmonary hypertension and pulmonary lung parenchymal disease, but these complications have not been reported after intrapleural administration. Pulmonary diseases, e.g., silicosis or asbestosis-like diseases, chronic bronchitis, bronchogenic carcinoma, and pleural plaques have been reported in association with inhaled talc.

4)Contents under pressure. The contents of the Sclerosol® Intrapleural Aerosol (sterile talc powder) canister are under pressure. The canister must not be punctured and should not be used or stored near heat or open flame.

Drug Interactions: It is not known whether the effectiveness of a second sclerosing agent after prior talc pleurodesis would be diminished by the absorptive properties of talc.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies on the carcinogenicity of talc have been performed using non-standard designs, which prevent firm conclusions on its carcinogenicity. With single intraperitoneal administration to mice at 20 mg and observation for at least 6 months, or 4 weekly doses administered intraperitoneally at 25 mg/dose to rats with observation for at least 84 weeks, tumor incidence was not increased. In these studies, the talc and its asbestos content were not characterized. Genotoxicity was assessed in cultures of rat pleural mesothelial cells (RPMC), as unscheduled DNA syntheses (UDS) and sister chromatid exchanges (SCEs). None of the talc samples (which were asbestos free) enhanced UDS or SCEs in treated cultures. No information is available on impairment of fertility in animals by talc.

Pregnancy: Pregnancy category B. An oral administration study has been performed in the rabbit at 900 mg/kg, approximately 5-fold higher than the human dose on mg/m2 basis, and has revealed no evidence of teratogenicity due to talc. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless it is clearly needed.

Pediatric Use: The safety and efficacy of Sclerosol Intrapleural Aerosol® (sterile talc powder) in pediatric patients have not been established.

Geriatric Use: The mean and median ages of patients treated with talc in the clinical studies table were 50-62 years. No analyses to specifically evaluate the safety and efficacy in the geriatric population have been reported.

Adverse Reactions

Talc administration has been described in more than 1500 patients reported in the medical literature. Patients with malignant pleural effusions were treated with talc via poudrage or slurry. In general, with respect to reported adverse experiences, it is difficult to distinguish the effects of talc from the effects of the procedure(s) associated with its administration. The most reported common adverse experiences were fever and pain. Almost all of the cases of fever, and over half of the cases of pain, were in patients who received diagnostic biopsies at the time of talc administration.

Infections: Empyema was a rare complication of talc administration and/or the procedure. Biopsies had been obtained prior to onset in over half the reported cases.

Respiratory: Rare instances of pneumonia, ARDS, dyspnea, bronchopleural fistula, hemoptysis, and pulmonary emboli have been reported.

Cardiovascular: Tachycardia, myocardial infarction, hypotension, hypovolemia, and asystolic arrest associated with surgery and/or anesthesia have been rarely reported.

Delivery Procedure: Adverse reactions due to the delivery procedure and the chest tube may include: infection at the site of thoracostomy or thoracoscopy, localized bleeding, and subcutaneous emphysema.

Chronic Toxicity: Lange et al. (Thorax 1988;43:559) reported on 114 consecutive cases of idiopathic spontaneous pneumothorax treated with talc poudrage (60 patients), or simple drainage (54 patients) via an intercostal tube. Pulmonary function tests (FEV1, VC, TLC, and RV) 22 go 35 years after treatment, showed no significant differences in the incidence of pleural changes between the two groups. Two patients treated with talc poudrage had more extensive pleural thickening with calcification. The mean total lung capacities were 89% of predicted in the talc group and 96% in the drainage only group. Fourteen patients (12 lifelong heavy smokers, 2 non-smokers) had airflow limitation (5 severe). Source and purity of the talc used was not reported. No cases of mesothelioma were reported. One case report noted the occurrence of adenocarcinoma of the chest wall two years after pleurodesis following 10 g of 1% iodized talc (administered for recurrent pneumothorax).

Overdosage

Overdosages have not been reported. See PRECAUTIONS: 3) Potential pulmonary complications.

Sclerosol Dosage and Administration

Sclerosol® Intrapleural Aerosol (sterile talc powder) is administered after adequate drainage of the effusion. It has been suggested that success of the pleurodesis is related to the completeness of the drainage of the pleural fluid, as well as full reexpansion of the lung, both of which will promote symphysis of the pleural surfaces.

The usual dosage of Sclerosol® Intrapleural Aerosol (sterile talc powder) is a single 4-8 g dose delivered intrapleurally from the spray canister (1-2 cans), which delivers talc at a rate of 0.4 g per second.

ADMINISTRATION PROCEDURE

Shake canister will before usage. Remove protective cap and securely attach actuator button with its delivery tube (either 15 cm or 25 cm) to the valve stem of canister.

Insert delivery tube through pleural trocar, taking care not to place the distal end of the delivery tube adjacent to the lung parenchyma or directly against the chest wall. While firmly holding the delivery tube and pleural trocar together in one hand, gently apply pressure to the actuator button on the canister. Sclerosol Intrapleural Aerosol® is not delivered by metered dose, but depends on the extent and duration of manual compression of the actuator button on the canister. The distal end of the delivery tube should be pointed in several different directions, while short bursts are administered in order to distribute the talc powder equally and extensively on all visceral and parietal pleural surfaces. For optimal distribution, always maintain the Sclerosol Intrapleural Aerosol® (sterile talc powder) canister in the upright position. After application, discard the canister and delivery tube. The duration of chest tube drainage following talc sclerosis is dictated by the clinical situation.

How is Sclerosol Supplied

NDC 63256-100-30: Sclerosol® Intrapleural Aerosol (sterile talc powder) contains 4.0 g of talc suspended in 26 g of inert propellant in a single-use aluminum canister. The canister if fitted with a continuous spray valve which delivers approximately 0.4 g of talc per second. This canister, attached to an actuator button, and two delivery tubes of 15 cm and 25 cm length, are supplied in a sterile, flexible plastic peel pack.

STORAGE: Warning: Contents under pressure. Do not puncture or incinerate container. Store between 59°F - 86°F (15°C - 30°C). Protect against sunlight and do not expose to a temperature above 120° F (49° C), or the canister may rupture. Avoid freezing. Shake well before using.

NOTE: The indented statement below is required by the Federal Government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs).

Warning: Contains CFC-12, a substance which harms public health and environment by destroying ozone in the upper atmosphere.

DISTRIBUTED BY: Bryan Corporation, Woburn MA 01801

Sclerosol
talc aerosol, powder Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63256-100 Route of Administration INTRAPLEURAL DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength Talc (Talc) Active 4.0 GRAM In 1 CANISTER Dichlorodifluromethane (CFC-12) Inactive Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63256-100-30 1 CANISTER In 1 CANISTER None
Revised: 10/2006Bryan Corporation More Sclerosol resources Sclerosol Side Effects (in more detail) Sclerosol Support Group 0 Reviews · Be the first to review/rate this drug Sclerosol Monograph (AHFS DI)

Actemra

Generic Name: tocilizumab (TOE si LIZ oo mab)
Brand Names: Actemra

What is tocilizumab?

Tocilizumab reduces the effects of a substance in the body that can cause inflammation.

Tocilizumab is used to treat moderate to severe rheumatoid arthritis in adults. It is sometimes given together with other arthritis medications.

Tocilizumab is also used to treat systemic juvenile idiopathic arthrits (or "Still disease") in children who are at least 2 years old. It is sometimes given together with methotrexate (Rheumatrex, Trexall).

Tocilizumab is usually given after other medications have been tried without successful treatment of symptoms.

Tocilizumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about tocilizumab? Serious and sometimes fatal infections may occur during treatment with tocilizumab. Contact your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, cough, sweating, feeling short of breath, diarrhea, weight loss, sores on your skin, painful urination, or feeling very tired.

Before you start treatment with tocilizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Tell your doctor if you have an active or recent infection, liver disease or hepatitis B, diabetes, diverticulitis, stomach ulcer or bleeding, high cholesterol, multiple sclerosis, HIV/AIDS, a weak immune system, or a history of cancer.

Tocilizumab can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections.

Do not receive a "live" vaccine while you are being treated with tocilizumab.

Treatment with tocilizumab may increase your risk of developing certain types of cancer. Talk to your doctor about your specific risk.

What should I discuss with my healthcare provider before I receive tocilizumab? Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure you can safely use tocilizumab, tell your doctor if you have any of these other conditions:

an active or recent infection (such as herpes, pneumonia, or yeast infection);

signs of infection such as fever, chills, cough, body aches, diarrhea, weight loss, painful urination, or coughing up blood;

open sores or skin wounds;

liver disease;

diverticulitis, stomach ulcer, or a history of stomach or intestinal bleeding;

diabetes;

a weak immune system;

high cholesterol;

hepatitis B (or if you are a carrier of the virus);

a nerve-muscle disease such as multiple sclerosis;

HIV or AIDS;

a history of cancer; or

if you are scheduled to receive any vaccines.

FDA pregnancy category C. It is not known whether tocilizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication..

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of tocilizumab on the baby.

It is not known whether tocilizumab passes into breast milk. You should not breast-feed while you are using tocilizumab.

Treatment with tocilizumab may increase your risk of developing certain types of cancer. Talk to your doctor about your specific risk.

How is tocilizumab given?

Before you start treatment with tocilizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Tocilizumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Tocilizumab must be given slowly, and the IV infusion can take 1 hour to complete.

This medication is usually given every 4 weeks.

Tocilizumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood need to be tested often. Visit your doctor regularly.

Contact your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, cough, sweating, feeling short of breath, diarrhea, weight loss, sores on your skin, painful urination, or feeling very tired.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment. If you need to have surgery, tell the surgeon ahead of time that you are using tocilizumab.

You may be treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your tocilizumab injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while receiving tocilizumab? Do not receive a "live" vaccine while using tocilizumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Gu?rin), and nasal flu vaccine.

Avoid being near people who are sick or have infections.

Tocilizumab side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Serious and sometimes fatal infections may occur during treatment with tocilizumab. Call your doctor right away if you have signs of infection such as:

fever, flu symptoms, mouth and throat ulcers, weight loss, feeling very tired;

sores in your mouth and throat or on your skin;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

purple or red pinpoint spots under your skin;

cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

pain or burning when you urinate.

Call your doctor at once if you have any of these other serious side effects:

severe stomach pain with constipation;

bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

painful blistering skin rash with burning, itching, or tingly feeling; or

upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

runny or stuffy nose, sinus pain, sore throat;

headache, dizziness;

itching; or

mild stomach cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tocilizumab?

Tell your doctor about all other medications you use, especially:

birth control pills;

a blood thinner such as warfarin (Coumadin);

cyclosporine (Gengraf, Neoral, Sandimmune);

digoxin (digitalis, Lanoxin, Lanoxicaps);

omeprazole (Prilosec);

sirolimus (Rapamune) or tacrolimus (Prograf);

theophylline (Elixophyllin, Theo-24, Uniphyl);

abatacept (Orencia), adalimumab (Humira), anakinra (Kineret) certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), or rituximab (Rituxan);

atorvastatin (Lipitor), lovastatin (Mevacor) and other cholesterol-lowering medications;

seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene);

a heart rhythm medication such as disopyramide (Norpace), procainamide (Pronestyl), or quinidine (Quin-G);

other drugs that weaken your immune system (such as cancer medicine or steroids); or

any other pain or arthritis medications (both prescription and over-the-counter) including methotrexate (Rheumatrex), aspirin, or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

This list is not complete and many other drugs may interact with tocilizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. More Actemra resources Actemra Side Effects (in more detail) Actemra Use in Pregnancy & Breastfeeding Actemra Drug Interactions Actemra Support Group 0 Reviews for Actemra - Add your own review/rating Actemra Prescribing Information (FDA) Actemra Monograph (AHFS DI) Actemra Advanced Consumer (Micromedex) - Includes Dosage Information Actemra Consumer Overview Actemra MedFacts Consumer Leaflet (Wolters Kluwer) Tocilizumab Professional Patient Advice (Wolters Kluwer) Compare Actemra with other medications Juvenile Idiopathic Arthritis Rheumatoid Arthritis Where can I get more information? Your doctor or pharmacist can provide more information about tocilizumab.

See also: Actemra side effects (in more detail)

Avonex Prefilled Syringes

Pronunciation: IN-ter-FEER-on BAY-ta
Generic Name: Interferon Beta-1a
Brand Name: Avonex
Avonex Prefilled Syringes are used for:

Treating relapsing forms of multiple sclerosis (MS) to reduce the number of flare-ups and to slow down the development of physical disability associated with MS.

Avonex Prefilled Syringes are a protein identical to one found in the body. Exactly how it works is not known. It is thought to interfere with other chemicals in the body that cause flare-ups of MS.

Do NOT use Avonex Prefilled Syringes if: you are allergic to any ingredient in Avonex Prefilled Syringes

Contact your doctor or health care provider right away if any of these apply to you.

Before using Avonex Prefilled Syringes:

Some medical conditions may interact with Avonex Prefilled Syringes. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Avonex Prefilled Syringes. Tell your health care provider if you are taking any other medicines, especially any of the following:

Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of side effects on the liver may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Avonex Prefilled Syringes may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Avonex Prefilled Syringes:

Use Avonex Prefilled Syringes as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Avonex Prefilled Syringes comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Avonex Prefilled Syringes refilled. Avonex Prefilled Syringes are usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Avonex Prefilled Syringes at home, a health care provider will teach you how to use it. Be sure you understand how to use Avonex Prefilled Syringes. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Avonex Prefilled Syringes if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Remove Avonex Prefilled Syringes from the refrigerator and allow it to warm to room temperature (about 30 minutes) before you use a dose. Do not use external heat sources (eg, hot water) to warm Avonex Prefilled Syringes. Avonex Prefilled Syringes are for injection into a muscle. Use the proper technique taught to you by your doctor. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Avonex Prefilled Syringes, use it as soon as possible and skip your dose the following day. Do not take Avonex Prefilled Syringes on 2 consecutive days. Return to your regular dosing schedule the following week. If you accidentally take Avonex Prefilled Syringes on 2 consecutive days or use more than your prescribed dose, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Avonex Prefilled Syringes.

Important safety information: Some patients become depressed or suicidal while taking Avonex Prefilled Syringes. If you begin to feel depressed or suicidal, contact your doctor. Avonex Prefilled Syringes may harm your liver. Your risk may be greater if you drink alcohol while you are using Avonex Prefilled Syringes. Talk to your doctor before drinking alcohol while you are using Avonex Prefilled Syringes. Avonex Prefilled Syringes commonly causes flu-like symptoms. Talk to your doctor about whether you should take a nonprescription medicine for pain or fever reduction before or after taking Avonex Prefilled Syringes. Lab tests, including complete blood cell counts, liver function tests, and thyroid function tests, may be performed while you use Avonex Prefilled Syringes. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Avonex Prefilled Syringes with caution in the ELDERLY; they may be more sensitive to its effects. Avonex Prefilled Syringes should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Avonex Prefilled Syringes may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Avonex Prefilled Syringes while you are pregnant. It is not known if Avonex Prefilled Syringes are found in breast milk. If you are or will be breast-feeding while you use Avonex Prefilled Syringes, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Avonex Prefilled Syringes:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; flu-like symptoms (eg, headache, tiredness, fever, chills, back pain, muscle aches, weakness); pain, redness, or swelling at the injection site; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in vision; chest pain; dark urine; depression; easy bruising or bleeding; extreme tiredness or weakness; fast or irregular heartbeat; feeling cold or hot all the time; increased urination at night; infection at the injection site; seizures; shortness of breath; suicidal thoughts or behaviors; swollen ankles; unexplained change in weight; yellowing of the eyes or skin.

See also: Avonex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Avonex Prefilled Syringes:

Store Avonex Prefilled Syringes in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If refrigeration is not available, Avonex Prefilled Syringes can be stored at or below 77 degrees F (26 degrees C) for up to 7 days. Protect from light. Keep Avonex Prefilled Syringes, as well as needles and syringes, out of the reach of children and away from pets.

General information: If you have any questions about Avonex Prefilled Syringes, please talk with your doctor, pharmacist, or other health care provider. Avonex Prefilled Syringes are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Avonex Prefilled Syringes. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Avonex resources Avonex Side Effects (in more detail) Avonex Use in Pregnancy & Breastfeeding Avonex Drug Interactions Avonex Support Group 14 Reviews for Avonex - Add your own review/rating Compare Avonex with other medications Multiple Sclerosis Neuritis

Interferon Beta-1a Prefilled Syringes

Pronunciation: IN-ter-FEER-on BAY-ta
Generic Name: Interferon Beta-1a
Brand Name: Avonex
Interferon Beta-1a Prefilled Syringes are used for:

Treating relapsing forms of multiple sclerosis (MS) to reduce the number of flare-ups and to slow down the development of physical disability associated with MS.

Interferon Beta-1a Prefilled Syringes are a protein identical to one found in the body. Exactly how it works is not known. It is thought to interfere with other chemicals in the body that cause flare-ups of MS.

Do NOT use Interferon Beta-1a Prefilled Syringes if: you are allergic to any ingredient in Interferon Beta-1a Prefilled Syringes

Contact your doctor or health care provider right away if any of these apply to you.

Before using Interferon Beta-1a Prefilled Syringes:

Some medical conditions may interact with Interferon Beta-1a Prefilled Syringes. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Interferon Beta-1a Prefilled Syringes. Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Interferon Beta-1a Prefilled Syringes may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Interferon Beta-1a Prefilled Syringes:

Use Interferon Beta-1a Prefilled Syringes as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Interferon Beta-1a Prefilled Syringes comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Interferon Beta-1a Prefilled Syringes refilled. Interferon Beta-1a Prefilled Syringes are usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Interferon Beta-1a Prefilled Syringes at home, a health care provider will teach you how to use it. Be sure you understand how to use Interferon Beta-1a Prefilled Syringes. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Interferon Beta-1a Prefilled Syringes if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Remove Interferon Beta-1a Prefilled Syringes from the refrigerator and allow it to warm to room temperature (about 30 minutes) before you use a dose. Do not use external heat sources (eg, hot water) to warm Interferon Beta-1a Prefilled Syringes. Interferon Beta-1a Prefilled Syringes are for injection into a muscle. Use the proper technique taught to you by your doctor. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Interferon Beta-1a Prefilled Syringes, use it as soon as possible and skip your dose the following day. Do not take Interferon Beta-1a Prefilled Syringes on 2 consecutive days. Return to your regular dosing schedule the following week. If you accidentally take Interferon Beta-1a Prefilled Syringes on 2 consecutive days or use more than your prescribed dose, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Interferon Beta-1a Prefilled Syringes.

Important safety information: Some patients become depressed or suicidal while taking Interferon Beta-1a Prefilled Syringes. If you begin to feel depressed or suicidal, contact your doctor. Interferon Beta-1a Prefilled Syringes may harm your liver. Your risk may be greater if you drink alcohol while you are using Interferon Beta-1a Prefilled Syringes. Talk to your doctor before drinking alcohol while you are using Interferon Beta-1a Prefilled Syringes. Interferon Beta-1a Prefilled Syringes commonly causes flu-like symptoms. Talk to your doctor about whether you should take a nonprescription medicine for pain or fever reduction before or after taking Interferon Beta-1a Prefilled Syringes. Lab tests, including complete blood cell counts, liver function tests, and thyroid function tests, may be performed while you use Interferon Beta-1a Prefilled Syringes. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Interferon Beta-1a Prefilled Syringes with caution in the ELDERLY; they may be more sensitive to its effects. Interferon Beta-1a Prefilled Syringes should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Interferon Beta-1a Prefilled Syringes may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Interferon Beta-1a Prefilled Syringes while you are pregnant. It is not known if Interferon Beta-1a Prefilled Syringes are found in breast milk. If you are or will be breast-feeding while you use Interferon Beta-1a Prefilled Syringes, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Interferon Beta-1a Prefilled Syringes:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; flu-like symptoms (eg, headache, tiredness, fever, chills, back pain, muscle aches, weakness); pain, redness, or swelling at the injection site; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

See also: Interferon Beta-1a side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Interferon Beta-1a Prefilled Syringes:

Store Interferon Beta-1a Prefilled Syringes in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If refrigeration is not available, Interferon Beta-1a Prefilled Syringes can be stored at or below 77 degrees F (26 degrees C) for up to 7 days. Protect from light. Keep Interferon Beta-1a Prefilled Syringes, as well as needles and syringes, out of the reach of children and away from pets.

General information: If you have any questions about Interferon Beta-1a Prefilled Syringes, please talk with your doctor, pharmacist, or other health care provider. Interferon Beta-1a Prefilled Syringes are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Interferon Beta-1a Prefilled Syringes. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Interferon Beta-1a resources Interferon Beta-1a Side Effects (in more detail) Interferon Beta-1a Use in Pregnancy & Breastfeeding Interferon Beta-1a Drug Interactions Interferon Beta-1a Support Group 27 Reviews for Interferon Beta-1a - Add your own review/rating Compare Interferon Beta-1a with other medications Multiple Sclerosis Neuritis

Sterile Talc

Prescribing Information
NDC 63256-200-05
Cat. # 1690

For Intrapleural Administration Only

Sterile Talc Description

Sterile Talc Powder is a sclerosing agent intended for intrapleural administration supplied in a single use 100 mL brown glass bottle, sealed with a gray, 20 mm stopper and covered with a flip-off seal. Each bottle contains a minimum of 5.0 g of Talc USP (Ultra 2000 Talc), either white or off-white to light gray, asbestos-free and brucite-free grade of talc of controlled particle size. The composition of the talc is ? 95% talc as hydrated magnesium silicate. The empirical formula of talc is Mg3 Si4 010 (OH)2 with a molecular weight of 379.3. Associated naturally occurring minerals include chlorite (hydrated aluminum and magnesium silicate.), dolomite (calcium and magnesium carbonate), calcite (calcium carbonate) and quartz. Talc is practically insoluble in water and in dilute solutions of acids and alkali hydroxides. The finished product has been sterilized by gamma irradiation.

Sterile Talc - Clinical Pharmacology Mechanism of Action

The extent of systemic absorption of talc after intrapleural administration has not been adequately studied. Systemic exposure could be affected by the integrity of the pleural surface, and therefore could be increased if talc is administered immediately following lung resection or biopsy.

Clinical Studies

The data demonstrating safety and efficacy of talc slurry administered via chest tube for the treatment of patients with malignant pleural effusions are from the published medical literature. The following prospective, randomized studies were designed to evaluate the risk of recurrence of malignant pleural effusions in patients with a variety of solid tumors. The studies compared talc slurry, instilled into the pleural cavity via chest tube, versus a concurrent control. In all studies, after maximal drainage of the pleural effusion, the investigator administered talc slurry via chest tube. Chest films documented response (defined as lack of recurrence of fluid for a period of time). Studies differed on the timing of the efficacy assessment. Zimmer et al. did not specify the time required evaluations. Ong et al. specified the assessment at one month. Sorensen et al. specified the assessment at 3-4 months. The remaining studies assessed response at the completion of the follow-up period.

Randomized Controlled Trials Using Talc Slurry as a Sclerosing Agent

* Two-sided p-value based on Fisher's exact test

a Patients were evaluable if chest x-rays were done to assess response per protocol.

The Sorensen study excluded patients if incomplete lung re-expansion was noted post drainage.

b Data per procedure (33 procedures in 29 evaluable patients, 3 patients with bilateral effusions).

c Plus lidocaine 1%, 20 mL.

d Plus lidocaine 1%, 10 mL.

REFERENCE TREATMENT RESPONSE RATE EVALUABLE PTS*
p value* RESPONSE RATE ALL PTS*
p value* Sorensen et al.
Eur J Respir Dis. 1984:
65(2):131-5 Talc Slurry
10g /250ml NS
vs.
Chest tube drainage alone 100% (9/9)
vs.
58% (7/12)
p=0.04 64% (9/14)
vs.
41% (7/17)
p=0.29 Noppen et al.
Acta Clin Belg 1997; 52(4):258-62 Talc Slurry
5g/50-ml NS
vs.
Bleomycin 1mg/kg/50ml NS 79% (11/14)
vs.
75% (9/12)
p=1.00 79% (11/14)
vs.
75% (9/12)
p=1.00 Zimmer PW et al.
Chest 1997;
112(2):430-434 Talc Slurry
5g/50 ml NSc
vs.
Bleomycin 60U/50 ml NSc 90% (17/19b)
vs.
79% (11/14 b)
p=0.63
Not Given Ong KC et al. Respirology 2000;
5:99-103 Talc Slurry
5g/150ml NSd
vs.
Bleomycin 1U/kg/150 ml NSd 89% (16/18)
vs.
70% (14/20)
p=0.24 64% (16/25)
vs.
56% (14/25)
p=0.77 Yim AP et al.
Ann Thorax Surg 1996; 62:1655-8 Talc Slurry 5g/50ml NS, lidocaine 2% 10 ml
vs. Talc Insufflation 5g powder 90%(26/29)
vs.
96% (27/28)
p=0.61 90% (26/29)
vs.
96% (27/28)
p=0.61

In single-arm studies of malignant pleural effusions from the published literature, variously defined "success" rates using talc slurry pleurodesis ranged from 75% to 100%.

Indications and Usage for Sterile Talc

Sterile Talc Powder, administered intrapleurally via chest tube, is indicated as a sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients.

Contraindications

None known

Warnings

None

Precautions

1. Future procedures: The possibility of the future diagnostic and therapeutic procedures involving the hemithorax to be treated must be considered prior to administering Sterile Talc Powder. Sclerosis of the pleural space may preclude subsequent diagnostic procedures of the pleura on the treated side. Talc sclerosis may complicate or preclude future ipsilateral lung resective surgery, including pneumonectomy for transplantation purposes.

2. Use in potentially curable disease: Talc has no known antineoplastic activity and should not be used alone for potentially curable malignancies where systemic therapy would be more appropriate, e.g., a malignant effusion secondary to a potentially curable lymphoma.

3. Pulmonary complications: Acute Pneumonitis and Acute Respiratory Distress Syndrome (ARDS) have been reported in association with intrapleural talc administration. Three of the case reports of ARDS have occurred after treatment with a relatively large talc dose (10 g) administered via intrapleural chest tube instillation. One patient died one month post treatment and two patients recovered without further sequelae.

DRUG INTERACTIONS

It is not known whether the effectiveness of a second sclerosing agent after prior talc pleurodesis would be diminished by the absorptive properties of talc.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies on the carcinogenicity of talc have been performed using non-standard designs which prevent firm conclusions on its carcinogenicity. With single intraperitoneal administration to mice at 20 mg and observation for at least 6 months or 4 weekly doses administered intraperitoneally at 25 mg/dose to rats with observation for at least 84 weeks, tumor incidence was not increased. In these studies the talc and its asbestos content were not characterized.

Genotoxicity was tested in cultures of rat pleural mesothelial cells (RPMC) as unscheduled DNA synthesis (UDS) and sister chromatid exchanges (SCEs). None of the talc samples (which were asbestos-free) induced enhancement of UDS or SCEs in treated cultures. No information is available on impairment of fertility in animals by talc.

Pregnancy: Pregnancy Category B. An oral administration study has been performed in the rabbit at 900 mg/kg. Approximately 5 fold higher than a human dose on mg/m2 basis, and has revealed no evidence of teratogenicity due to talc. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless the benefit outweighs the risk.

Pediatric Use: The safety and efficacy of Sterile Talc Powder in pediatric patients have not been established.

Geriatric use: The estimated mean and median ages of patients treated with talc slurry from clinical studies (single-arm or randomized) were 60 and 62 years, respectively. No analyses to specifically evaluate the safety and efficacy in the geriatric population have been reported.

Adverse Reactions

Intrathoracic administration of talc slurry has been described in medical literature reports involving more that 2000 patients. Patients with malignant pleural effusions were treated with talc via poudrage or slurry. In general, with respect to reported adverse experiences, it is difficult to distinguish the effects of talc from the effects of the procedure(s) associated with its administration. The most often reported adverse experiences to intrapleurally-administered talc were fever and pain.

Infection: Complications reported include empyema.

Respiratory: Complications reported include hypoxemia, dyspnea, unilateral pulmonary edema, pneumonia, ARDS, brochopleural fistula, hemoptysis and pulmonary emboli.

Cardiovascular: Complications reported included tachycardia, myocardial infarction, hypotension, hypovolemia and asystolic arrest

Delivery Procedure: Adverse reactions due to the delivery procedure and the chest tube may include: pain, infection at the site of thoracostomy or thoracoscopy, localized bleeding, and subcutaneous emphysema.

Chronic Toxicity: Since patients in clinical studies had a limited life expectancy, data on chronic toxicity are limited

Overdosage

No definite relationship between dose and toxicity has been established. Excessive talc may be partially removed with saline lavage.

Sterile Talc Dosage and Administration

Sterile Talc Powder should be administered after adequate drainage of the effusion. The success of the pleurodesis appears to be related to the completeness of the drainage of the pleural fluid, as well as the full re-expansion of the lung, both of which will promote symphysis of the pleural surfaces.

The recommended dose is 5 g, dissolved in 50 - 100 ml Sodium Chloride Injection, USP. Although the optimal dose for effective pleurodesis is unknown, 5 g was the dose most frequently reported in the published literature.

Talc Preparation

Prepare the talc slurry using aseptic technique in an appropriate laminar flow hood. Remove talc container from packaging. Remove protective flip-off seal.

Each brown bottle contains 5 g of Sterilized Talc Powder. To dispense the contents:

Using a 16 gauge needle attached to a 60-mL LuerLok syringe, measure and draw up 50 mL of Sodium Chloride Injection, USP. Vent the talc bottle using a needle. Slowing inject the 50 mL of Sodium Chloride Injection, USP into the bottle. For doses more than 5 g, repeat this procedure with a second bottle. Swirl the bottle(s) to disperse the talc powder and continue swirling to avoid settling of the talc in the slurry. Each bottle will contain 5 g Sterile Talc Powder dispersed in 50 mL of Sodium Chloride Injection, USP. Divide the content of each bottle into two 60 mL irrigation syringes by withdrawing 25 mL of the slurry into each syringe with continuous swirling. QS each syringe with Sodium Chloride Injection, USP to a total volume of 50 mL in each syringe. Draw air into each syringe to the 60 mL mark to serve as a headspace for mixing prior to administration. When appropriately labeled, each syringe contains 2.5 g of Sterile Talc in 50 mL of Sodium Chloride Injection, USP with an air headspace of 10 mL. Once the slurry has been made, use within 12 hours or discard and prepare fresh slurry. Label the syringes appropriately noting the expiration date and time, with the statement “For Pleurodesis Only – NOT FOR IV ADMINISTRATION,” the identity of the patient intended to receive this material and a cautionary statement to SHAKE WELL before use. Prior to administration, completely and continuously agitate the syringes to evenly redisperse the talc and avoid settlement. Immediately prior to administration, vent the 10mL air headspace from each syringe. Attach the adapter and place a syringe tip on the adapter. Maintain continuous agitation of the syringes.

NOTICE: Shake well before installation. Each 25 ml of prepared slurry in the syringe contains 1.25 g of talc. NOT FOR IV ADMINISTRATION.

Administration

Administer the talc slurry through the chest tube by gently applying pressure to syringe plunger and empty the contents of the syringe into the chest cavity. After application, discard the empty syringe according to general hospital procedures. After the talc slurry has been administered through the chest tube into the pleural cavity, the chest tube may be flushed with 10- 25 mL sodium chloride solution to ensure that the complete dose of talc is delivered.

Following introduction of the talc slurry, the chest drainage tube is clamped, and the patient is asked to move, at 20 to 30 minute intervals, from supine to alternating decubitus positions, so that over a period of about 2 hours the talc is distributed within the chest cavity. Recent evidence suggests that this step may not be necessary.

At the end of this period, the chest drainage tube is unclamped, and the excess saline is removed by the routine continual external suction on the tube.

How is Sterile Talc Supplied

NDC 63256-200-05 Sterile Talc Powder is supplied in a 100 mL brown glass bottle containing 5 g of talc. The sterile bottle is closed with a gray stopper and covered with a flip-off seal.

Storage: Store at Room Temperature (18-25°C). Protect against sunlight.

DISTRIBUTED BY: Bryan Corporation. Woburn, MA 01801

Version: Original Sep 2003

TALC
talc aerosol, powder Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63256-200 Route of Administration INTRAPLEURAL DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength Talc (Talc) Active 5 GRAM In 1 CANISTER Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63256-200-05 1 CANISTER In 1 CANISTER None
Revised: 10/2006Bryan Corporation More Sterile Talc resources Sterile Talc Side Effects (in more detail)Sterile Talc Support Group0 Reviews · Be the first to review/rate this drug Sclerosol Monograph (AHFS DI)

Tysabri

Generic Name: natalizumab (nat ta LIZ yoo mab)
Brand Names: Tysabri

What is natalizumab?

Natalizumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Natalizumab is used in to treat relapsing forms of multiple sclerosis.

Natalizumab is also used to treat moderate to severe Crohn's disease in adults. It is usually given after other Crohn's disease medications have been tried without successful treatment of this condition.

Natalizumab may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about natalizumab? Natalizumab may cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you any change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Natalizumab is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

During your natalizumab treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you develop any symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

You should also call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.

What should I discuss with my healthcare provider before receiving natalizumab? Natalizumab may cause a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.

You should not receive natalizumab if you are allergic to it, or if you have ever had a brain infection called progressive multifocal leukoencephalopathy.

If you have any of these other conditions, you may need a dose adjustment or special tests:

HIV or AIDS;

herpes or shingles;

leukemia, lymphoma;

if you have had a recent organ transplant; or

if you are being treated with chemotherapy or radiation.

FDA pregnancy category C. It is not known whether natalizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Natalizumab can pass into breast milk and may harm a nursing baby. You should not breast-feed while receiving natalizumab. How is natalizumab given?

Natalizumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting every 4 weeks. Natalizumab must be given slowly, and the IV infusion can take up to 1 hour to complete.

Before you receive your first dose of natalizumab, your doctor may want you to have an MRI to make sure you do not have any signs of a brain infection.

After you receive natalizumab, your caregivers may want to watch you for at least 1 hour in case you have any type of reaction to the medication. An allergic reaction can occur up to 2 hours after your infusion.

During your treatment, it is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Your doctor may also want to check you for several weeks after you stop using natalizumab. Do not miss any scheduled visits to your doctor.

Natalizumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your natalizumab injection.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while receiving natalizumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Natalizumab side effects Get emergency medical help if you have any of these signs of an allergic reaction: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting. Call your doctor at once if you have a serious side effect such as:

change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);

upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

pain or burning when you urinate;

cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

flu symptoms, sores or white patches in your mouth or on your lips;

vaginal itching or discharge;

tooth pain, gum pain or swelling; or

flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).

Less serious side effects may include:

headache;

tired feeling;

joint or muscle pain;

stomach pain, diarrhea;

mild skin rash;

depression;

painful menstrual cramps; or

cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect natalizumab?

Tell your doctor about all other medicines you use, especially drugs that may affect the immune system such as:

drugs that weaken your immune system (such as cancer medicine or steroids);

cyclosporine (Neoral, Sandimmune, Gengraf);

mercaptopurine (Purinethol);

methotrexate (Rheumatrex, Trexall);

mycophenolate mofetil (CellCept);

azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel);

basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);

interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif, Betaseron, or Actimmune); or

sirolimus (Rapamune), tacrolimus (Prograf).

This list is not complete and other drugs may interact with natalizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Tysabri resources Tysabri Side Effects (in more detail) Tysabri Use in Pregnancy & Breastfeeding Tysabri Drug Interactions Tysabri Support Group 24 Reviews for Tysabri - Add your own review/rating Tysabri Prescribing Information (FDA) Tysabri Monograph (AHFS DI) Tysabri Advanced Consumer (Micromedex) - Includes Dosage Information Tysabri Consumer Overview Tysabri MedFacts Consumer Leaflet (Wolters Kluwer) Natalizumab Professional Patient Advice (Wolters Kluwer) Compare Tysabri with other medications Crohn's Disease, Maintenance Multiple Sclerosis Where can I get more information? Your doctor or pharmacist can provide more information about natalizumab.

See also: Tysabri side effects (in more detail)

Laxido Orange, powder for oral solution, sugar-free

1. Name Of The Medicinal Product

Laxido Orange, powder for oral solution.

2. Qualitative And Quantitative Composition

Each sachet contains the following quantitative composition of active ingredients:

Macrogol 3350 13.125g

Sodium Chloride 350.7mg

Sodium Hydrogen Carbonate 178.5mg

Potassium Chloride 46.6mg

The content of electrolyte ions per sachet following reconstitution in 125ml of water is equivalent to:

Sodium 65mmol/l

Chloride 53mmol/l

Hydrogen Carbonate (Bicarbonate) 17mmol/l

Potassium 5.4mmol/l

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for oral solution. Single-dose sachet containing a free flowing white powder.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of chronic constipation. Laxido Orange is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

4.2 Posology And Method Of Administration

Laxido Orange is for oral use.

Chronic Constipation:

A course of treatment for chronic constipation with Laxido Orange does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's Disease, or induced by regular constipating medication in particular opioids and antimuscarinics.

Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily.

Children below 12 years old: Not recommended.

Faecal Impaction:

A course of treatment for faecal impaction with Laxido Orange does not normally exceed 3 days.

Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period.

Children below 12 years old: Not recommended.

Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than 2 sachets are taken in any one hour.

Patients with renal insufficiency: No dosage change is necessary for the treatment of constipation or faecal impaction.

Administration:

Each sachet should be dissolved in 125 ml water. For use in faecal impaction, 8 sachets may be dissolved in 1 litre of water.

4.3 Contraindications

Laxido Orange is contraindicated in intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract (e.g. ulcerative colitis, Crohn's disease and toxic megacolon).

Hypersensitivity to the active substances or any of the excipients.

4.4 Special Warnings And Precautions For Use

The faecal impaction diagnosis should be confirmed by appropriate physical or radiological examination of the rectum and abdomen.

Mild adverse drug reactions are possible as indicated in Section 4.8. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Laxido Orange should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interactions of Laxido Orange with other medicinal products. However, macrogol 3350 raises the solubility of medicinal products that are soluble in alcohol and mainly insoluble in water. It is a theoretical possibility that absorption of these drugs could be reduced transiently. Therefore, other medicines should not be taken orally for one hour before and for one hour after taking Laxido Orange.

4.6 Pregnancy And Lactation

There is no experience with the use of Laxido Orange during pregnancy and lactation and it should not be used during pregnancy and lactation unless clearly necessary.

4.7 Effects On Ability To Drive And Use Machines

Laxido Orange has no influence on the ability to drive and use machines.

4.8 Undesirable Effects

Immune System Disorders:

Allergic reactions are possible.

Gastro-intestinal Disorders:

Potential gastro-intestinal effects that may occur include abdominal distension and pain, borborygmi and nausea. Mild diarrhoea may also occur, but normally resolves after dose reduction.

4.9 Overdose

Severe distension or pain can be treated using nasogastric aspiration. Vomiting or diarrhoea may induce extensive fluid loss, possibly leading to electrolyte disturbances that should be treated appropriately.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

Macrogol 3350 induces a laxative effect through its osmotic action in the gut. This product also contains electrolytes to ensure that there is no overall gain or loss of water, potassium or sodium.

Clinical studies using the listed active substances for the treatment of chronic constipation have shown that the dose required to produce normally formed stools tends to decrease over time. For most patients, the maintenance dose will be one to two sachets per day (adjusted according to individual response).

Comparative studies in faecal impaction using active controls (e.g. enemas) have not been performed. However, results from a non-comparative study have shown that, from a population of 27 adult patients, the listed combination of active substances cleared faecal impaction in 12/27 (44%) patients after one day's treatment, increasing to 23/27 (85%) following two days' treatment and 24/27 (89%) recovered at the end of three days.

5.2 Pharmacokinetic Properties

Macrogol 3350 is virtually unabsorbed from the gastro-intestinal tract and is excreted, unaltered, in faeces. Any macrogol 3350 that enters the systemic circulation is excreted in urine.

5.3 Preclinical Safety Data

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, although no tests of its effects on reproduction or genotoxicity have been conducted.

There are no long-term animal toxicity or carcinogenicity studies involving macrogol 3350, although there are toxicity studies using high levels of orally administered high-molecular weight macrogols that provide evidence of safety at the recommended therapeutic dose.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Acesulfame Potassium (E950)

Orange Flavour

(Orange flavour contains the following constituents: natural flavouring substances and preparations, maltodextrin and propylene glycol [E1520])

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Sachet: Two years.

Reconstituted solution: Six hours.

6.4 Special Precautions For Storage

Sachet: Store below 25°C.

Reconstituted solution: Store covered in a refrigerator (2°C to 8°C).

6.5 Nature And Contents Of Container

The sachet is composed of paper, low density polyethylene and aluminium.

Sachets are packed in cartons of 2, 8, 10, 20, 30, 50 and 100.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Galen Limited

Seagoe Industrial Estate

Craigavon

BT63 5UA

8. Marketing Authorisation Number(S)

PL 21590/0087.

9. Date Of First Authorisation/Renewal Of The Authorisation

01 May 2008.

10. Date Of Revision Of The Text

10 February 2010

Laxido Orange, powder for oral solution, sugar-free
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