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HIV Infection Medications

Definition of HIV Infection: HIV infection is a viral infection caused by the human immunodeficiency virus (HIV) that gradually destroys the immune system, resulting in infections that are hard for the body to fight.

Drugs associated with HIV Infection

The following drugs and medications are in some way related to, or used in the treatment of HIV Infection. 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 HIV Infection

Micromedex Care Notes:

Human Immunodeficiency Virus And Acquired Immune Deficiency SyndromeSexually Transmitted DiseasesSexually Transmitted Diseases In Adolescents

Medical Encyclopedia:

AIDSHIV infection

Drugs.com Health Center:

HIV/AIDS Center
Drug List:Accesspak-For-Hiv-Pep-Basic Accesspak-For-Hiv-Pep-Expanded-With-Kaletra Accesspak-For-Hiv-Pep-Expanded-With-Viracept Agenerase Aptivus Atripla Carimune-Igiv Combivir Complera Crixivan Edurant Emtriva Epivir Epivir-Hbv Epzicom Flebogamma Fortovase Fuzeon Gamimune Gamimune-N-10-Igiv Gammagard Gammagard-S-D-Igiv Gammaplex-Igiv Gammar-Piv Hivid Intelence Invirase Isentress Iveegam-En-Igiv Kaletra Lexiva Norvir Octagam Panglobulin-Nf Polygam-S-D-Igiv Prezista Privigen Rescriptor Retrovir Reyataz Sandoglobulin-Igiv Selzentry Sustiva Trizivir Truvada Videx-Chewable-Dispersible-Buffered-Tablets Videx-Ec-Delayed-Release-Enteric-Coated-Capsules Viracept Viramune Viramune-Xr-Extended-Release-Tablets Viread Zerit Ziagen

Immune globulins

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.

In healthy individuals immune globulins are made by plasma cells when exposed by an immunogen such as a virus. Immune globulins act as antibodies against an infection. They are made up of different classes and subclasses of molecules.

The immune globulin used for therapeutic purposes is made from healthy human blood that has a high level of antibodies. Immune globulins are given to those with a weak immune system to strengthen or act as the body

octagam®10%

1. Name Of The Medicinal Product

OCTAGAM

solution for infusion

2. Qualitative And Quantitative Composition

2.1 Active ingredients

Human normal immunoglobulin (IVIg)

2.2 Quantitative composition:

1 ml solution contains:

Protein 100 mg of which IgA IgM

Distribution of IgG subclasses:

IgG1 ca. 60% IgG2 ca. 32% IgG3 ca. 7% IgG4 ca. 1%

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for infusion

The liquid preparation is clear to slightly opalescent and colourless to slightly yellow. The pH of the liquid preparation is 4.5 – 5.0, the osmolality is

4. Clinical Particulars 4.1 Therapeutic Indications

Replacement therapy in:

• Primary immunodeficiency syndromes such as:

- congenital agammaglobulinaemia and hypogammaglobulinaemia

- common variable immunodeficiency

- severe combined immunodeficiency

- Wiskott Aldrich syndrome

• Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

• Children with congenital AIDS and recurrent infections.

Immunomodulation

• Idiopathic thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

• Guillain Barr? syndrome

• Kawasaki disease

Allogeneic bone marrow transplantation

4.2 Posology And Method Of Administration

Posology

The dose and dosage regimen is dependent on the indication.

In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.

The following dosage regimens are given as a guideline:

Replacement therapy in primary immunodeficiency syndromes

• The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4 – 6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4 - 0.8 g/kg, followed by at least 0.2 g/kg every three weeks.

• The dose required to achieve a trough level of 6 g/l is of the order of 0.2 - 0.8 g/kg/month.

• The dosage interval when steady state has been reached, varies from 2 to 4 weeks.

• Trough levels should be measured in order to adjust the dose and dosage interval.

Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections:

• The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.

Idiopathic Thrombocytopenic Purpura:

• For the treatment of an acute episode, 0.8 - 1 g/kg on day one, which may be repeated once within 3 days, or 0.4 g/kg daily for two to five days.

• The treatment can be repeated if relapse occurs.

Guillain Barr? syndrome:

0.4 g/kg/day for 3 to 7 days. Experience in children is limited.

Kawasaki disease:

1.6 - 2 g/kg should be administered in divided doses over two to five days or 2 g/kg as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.

Allogeneic Bone Marrow Transplantation:

• Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant. For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored.

• The starting dose is normally 0.5 g/kg/week, starting seven days before transplantation and for up to 3 months after transplantation.

• In the case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal.

The dosage recommendations are summarised in the following table:

Indication

Dose

Frequency of injection

Replacement therapy in primary immunodeficiency

- Starting dose:

0.4 - 0.8 g/kg

- Thereafter:

0.2 - 0.8 g/kg

every 2 - 4 weeks to obtain IgG trough level of at least 4 - 6 g/l

Replacement therapy in secondary immunodeficiency

0.2 - 0.4 g/kg

every 3 - 4 weeks to obtain IgG trough level of at least 4 - 6 g/l

Children with AIDS

0.2 – 0.4 g/kg

every 3 - 4 weeks

Immunomodulation:

Idiopathic Thrombocytopenic Purpura

0.8 - 1 g/kg

on day 1, possibly repeated once within 3 days

0.4 g/kg/day

for 2-5 days

Guillain Barr? syndrome

0.4 g/kg/day

for 3-7 days

Kawasaki syndrome

1.6 - 2 g/kg

in several doses for 2 - 5 days in association with acetylsalicylic acid

2 g/kg

in one dose in association with acetylsalicylic acid

Allogeneic bone marrow transplantation:

- treatment of infections and prophylaxis of graft versus host disease

0.5 g/kg

every week from day -7 up to 3 months after transplantation

- Persistent lack of antibody production

0.5 g/kg

every month until IgG levels return to normal

Method of administration

Octagam 10% should be infused intravenously at an initial rate of 0.01 to 0.02 mL/kg body weight per minute for 30 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.12 mL/kg/ body weight per minute.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients of Octagam 10% .

Hypersensitivity to homologous immunoglobulins, especially in the very rare cases of IgA deficiency when the patient has antibodies against IgA.

4.4 Special Warnings And Precautions For Use

Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under “4.2 Method of administration" must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.

Certain adverse reactions may occur more frequently:

• in case of high rate of infusion

• in patients with hypo- or agammaglobulinaemia, with or without IgA deficiency

• in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion

True hypersensitivity reactions are rare. They can occur in very seldom cases of IgA deficiency with anti-IgA antibodies.

Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.

Potential complications can often be avoided by ensuring:

• that patients are not sensitive to human normal immunoglobulin by initially injecting the product slowly (0.01 to 0.02 mL/kg body weight per minute);

• that patients are carefully monitored for any symptoms throughout the infusion period; in particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product to Octagam 10% or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.

There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients. Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with diseases which increase blood viscosity).

Cases of acute renal failure have been reported in patients receiving IVIg therapy. In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65.

In case of renal impairment, IVIg discontinuation should be considered. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products containing various excipients such as sucrose, glucose and maltose, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number. In patients at risk, the use of IVIg products not containing such excipients may be considered.

In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.

In all patients, IVIg administration requires:

• adequate hydration prior to the infusion of IVIg

• monitoring of urine output

• monitoring of serum creatinine levels

• avoidance of concomitant use of loop diuretics

In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the side effect.

In case of shock, standard medical treatment for shock should be implemented.

Some types of blood glucose testing systems may falsely interpret the maltose (90 mg/ml) contained in Octagam 10% as glucose. This may result in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin and cases of true hypoglycaemia may go untreated if the hypoglycaemic state is masked by falsely elevated glucose readings. For further details see Section 4.5.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV.

The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.

There is a reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.

It is strongly recommended that every time that Octagam 10% is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In order to infuse any product that may remain in the infusion tubing at the end of the infusion the tubing may be flushed with either 0.9% saline or 5% dextrose solution.

Live attenuated virus vaccines

Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore, patients receiving measles vaccine should have their antibody status checked.

Interference with serological testing

After injection of immunoglobulin the transitory rise of various passively transferred antibodies in the patients blood may result in misleading positive results in serological testing.

Passive transmission of antibodies to erythrocyte antigens, e.g. A, B or D may interfere with some serological tests for red cell allo-antibodies, for example the antiglobulin test (e.g. Coombs Test).

Blood Glucose Testing

Some types of blood glucose testing systems (for example, those based on the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods) falsely interpret the maltose (90 mg/ml) contained in Octagam 10% as glucose. This may result in falsely elevated glucose readings during an infusion and for a period of about 15 hours after the end of the infusion and, consequently, in the inappropriate administration of insulin, resulting in life-threatening or even fatal hypoglycemia. Also, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings. Accordingly, when administering Octagam 10% or other parenteral maltose- containing products, the measurement of blood glucose must be done with a glucose-specific method.

The product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose- containing parenteral products.

4.6 Pregnancy And Lactation

The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

In general, various allergic and hypersensitivity type of reactions and headache, chills, back pain, chest pain, fever, cutaneous reactions, vomiting, arthralgia, low blood pressure and nausea may occasionally occur. Reactions to intravenous immunoglobulins tend to be related to the dose and the rate of infusion.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

MedDRA 8.1 Coded

Common

> 1% - <10%

Uncommon

> 0.1% - <1%

Very Rare

< 0.01%

Blood and lymphatic system disorders

leukopenia;

haemolytic anaemia

Immune system disorders

hypersensitivity

anaphylactic shock;

anaphylactic reaction;

anaphylactoid reaction;

angioneurotic oedema;

face oedema

Psychiatric disorders

agitation

Nervous system disorders

headache

cerebrovascular accident;

meningitis aseptic;

migraine;

dizziness;

paraesthesia

Cardiac disorders

myocardial infarction;

tachycardia;

palpitations;

cyanosis

Vascular disorders

thrombosis;

peripheral circulatory failure;

hypotension;

hypertension

Respiratory, thoracic and mediastinal disorders

respiratory failure;

pulmonary embolism;

pulmonary oedema;

bronchospasm;

dyspnoea;

cough

Gastrointestinal disorders

nausea

vomiting;

diarrhoea;

abdominal pain

Skin and subcutaneous tissue disorders

eczema;

urticaria;

rash;

rash erythematous;

dermatitis;

pruritus;

alopecia

Musculoskeletal and connective tissue disorders

back pain

arthralgia;

myalgia

Renal and urinary disorders

renal failure acute

General disorders and administration site conditions

fever;

fatigue;

injection site reaction

chills;

chest pain

hot flush;

flushing;

hyperhidrosis;

malaise

Investigations

hepatic enzymes increased;

blood glucose false positive

Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/haemolysis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin.

Increase in serum creatinine level and/or acute renal failure have been observed.

Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.

Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.

Standard measures are taken to prevent infections resulting from the use of medicinal products prepared from human blood or plasma. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens. For safety with respect to transmissible agents, see 4.4.

4.9 Overdose

Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration,

ATC-Code: J06B A02

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.

Human normal immunoglobulin contains the IgG antibodies present in the normal population.

It is prepared from pooled plasma from not fewer than 3500 donations. It has a distribution of immunoglobulin G-subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low Immunoglobulin G level to the normal range.

The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

Clinical Studies

In a prospective, open-label, multicentre phase III trial, the efficacy and safety of Octagam 10% was studied in patients suffering from idiopathic (immune) thrombocytopenic purpura (ITP). Octagam 10% was infused on 2 consecutive days at a dose of 1 gram/kg/day, and patients were observed for a period of 21 days and at a follow-up visit on Day 63 post-infusion. Haematology parameters were assessed on Days 2 to 7, 14 and 21.

A total of 31 subjects were included in the analysis; 15 were subjects with chronic ITP, 15 were newly-diagnosed, and 1 subject was incorrectly enrolled in the study (had no ITP) and was therefore excluded from the efficacy analysis.

In total, 25 subjects (83%) showed a clinical response. A higher clinical response rate was seen in the newly-diagnosed cohort (93%) than in the chronic ITP cohort (73%). In subjects with a response, the median time to platelet response was 2 days, with a range of 1 to 5 days.

In 24 subjects (77%), Octagam 10% was given at the maximum allowed infusion rate of 0.06 mL/kg/min. Following a Protocol Amendment, 2 patients of the presented analysis received the product at a rate of 0.08 mL/kg/min which was uneventful in both cases. In the continuation of this on-going study, 22 subjects have been treated with the maximum allowed infusion rate of 0.12 mL/kg/min.

In 9 of 62 infusions (14.5%) treatment-related infusional AE were observed. The most common drug-related AE was headache, followed by tachycardia and pyrexia. There was no case of haemolysis related to the study drug. Pre-treatment to alleviate infusion-related intolerability was not given.

5.2 Pharmacokinetic Properties

Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.

Human normal immunoglobulin has an average half life ranging from 26 to 41 days, as measured in immunodeficient patients. This half-life may vary from patient to patient, in particular in primary immunodeficiency.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical Safety Data

Immunoglobulins are normal constituents of the human body. In animals, acute toxicity testing is of no relevance because of the excessive dose required. Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable. Effects of the product on the immune system of the newborn have not been studied.

Virus inactivation by solvent/detergent treatment is carried out with Tri-n-butyl phosphate (TNBP) and Octoxynol (Triton X-100). The maximum permitted amounts in the final product are 1 µg/ml TNBP and 5 µg/ml Octoxynol. In the doses in which Octagam 10% is administered, these substances have been found to have no toxic effects in animal tests concerning acute and chronic toxicity, teratogenicity and embryotoxicity.

Since clinical experience provides no hint for tumorigenic or mutagenic effects of immunoglobulins, experimental studies, particularly in heterogolous species, are not considered necessary.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Maltose

Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store in a refrigerator (2°C – 8°C).

Keep the container in the outer carton in order to protect from light.

Do not freeze.

Do not use after expiry date.

Because of the possibility of bacterial contamination, any remaining contents must be discarded.

Within its shelf-life, the product may be stored below 25 °C for up to 3 months, without being refrigerated again during this period, and must be withdrawn if not used after this.

6.5 Nature And Contents Of Container

Package size

Contents

Container

Octagam 20 ml

2 g

30 ml injection vial

Octagam 50 ml

5 g

70 ml infusion bottle

Octagam 100 ml

10 g

100 ml infusion bottle

Octagam 200 ml

20 g

250 ml infusion bottle

Not all pack sizes may be marketed.

The primary container is made of type II glass closed with bromobutyl rubber stopper.

Components used in the packaging of Octagam 10% are latex-free.

6.6 Special Precautions For Disposal And Other Handling

The product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent.

Do not use solutions that are cloudy or have deposits.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Octapharma Ltd, The Zenith Building, 26 Spring Gardens, Manchester, M2 1AB, United Kingdom.

8. Marketing Authorisation Number(S)

PL 10673/0028

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation/Renewal of the Authorisation: 20/05/2008

10. Date Of Revision Of The Text

20/05/2008

Gammagard IGIV

Generic Name: immune globulin (intravenous) (IGIV) (im MYOON GLOB yoo lin)
Brand Names: Carimune, Flebogamma, Gammagard (obsolete), Gammagard S/D, Gammaplex, Gammar-P I.V., Gamunex, Octagam, Polygam S/D, Privigen, Sandoglobulin

What is immune globulin intravenous (IVIG)?

Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin is used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.

Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

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

What is the most important information I should know about immune globulin?

Immune globulin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using immune globulin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before using immune globulin intravenous, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using immune globulin? You should not use this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

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

kidney disease;

diabetes (especially if you use insulin);

a history of stroke or blood clot;

heart disease or high blood pressure;

a condition called paraproteinemia; or

if you are over 65 years old.

FDA pregnancy category C. It is not known whether immune globulin 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 if immune globulin 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.

How is immune globulin intravenous given?

Immune globulin intravenous is injected into a vein through an IV. You may be shown how to use an IV 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, IV tubing, and other items used to inject the medicine.

IVIG should not be injected into a muscle or under the skin.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Throw away any unused medicine that is left over after injecting your dose.

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.

IVIG is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Some brands of immune globulin should be stored in a refrigerator, while others can be kept at room temperature. Follow the directions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze. What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

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 using immune globulin? Do not receive a "live" vaccine while using IVIG. 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), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Gu?rin), and nasal flu vaccine. Immune globulin 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. Call your doctor at once if you have a serious side effect such as:

urinating less than usual or not at all;

drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

swelling, weight gain, feeling short of breath;

wheezing, chest tightness;

feeling like you might pass out;

fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or

pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Less serious side effects may include:

mild headache;

dizziness;

tired feeling;

back pain, muscle cramps;

minor chest pain; or

flushing (warmth, redness, or tingly feeling).

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 immune globulin?

Immune globulin can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

lithium (Lithobid);

methotrexate (Rheumatrex, Trexall);

pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;

medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and other drugs may interact with immune globulin. 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 Gammagard resources Gammagard Side Effects (in more detail) Gammagard Use in Pregnancy & Breastfeeding Gammagard Drug Interactions Gammagard Support Group 0 Reviews for Gammagard - Add your own review/rating Compare Gammagard with other medications Autoimmune Neutropenia Bone Marrow Transplantation Chronic Lymphocytic Leukemia Evan's Syndrome HIV Infection Idiopathic Thrombocytopenic Purpura Kawasaki Disease Polymyositis/Dermatomyositis Primary Immunodeficiency Syndrome Where can I get more information? Your pharmacist can provide more information about immune globulin intravenous.

See also: Gammagard side effects (in more detail)

Gammar-P I.V. IGIV

What is immune globulin intravenous (IVIG)?

Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

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

What is the most important information I should know about immune globulin?

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

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

kidney disease;

diabetes (especially if you use insulin);

a history of stroke or blood clot;

heart disease or high blood pressure;

a condition called paraproteinemia; or

if you are over 65 years old.

How is immune globulin intravenous given?

IVIG should not be injected into a muscle or under the skin.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Throw away any unused medicine that is left over after injecting your dose.

IVIG is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Call your doctor for instructions if you miss a dose of this medication.

urinating less than usual or not at all;

drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

swelling, weight gain, feeling short of breath;

wheezing, chest tightness;

feeling like you might pass out;

fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or

pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Less serious side effects may include:

mild headache;

dizziness;

tired feeling;

back pain, muscle cramps;

minor chest pain; or

flushing (warmth, redness, or tingly feeling).

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 immune globulin?

Immune globulin can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

lithium (Lithobid);

methotrexate (Rheumatrex, Trexall);

medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

More Gammar-P I.V. resources Gammar-P I.V. Side Effects (in more detail) Gammar-P I.V. Use in Pregnancy & Breastfeeding Gammar-P I.V. Drug Interactions Gammar-P I.V. Support Group 0 Reviews for Gammar-P I.V. - Add your own review/rating Compare Gammar-P I.V. with other medications Autoimmune Neutropenia Bone Marrow Transplantation Chronic Lymphocytic Leukemia Evan's Syndrome HIV Infection Idiopathic Thrombocytopenic Purpura Kawasaki Disease Polymyositis/Dermatomyositis Primary Immunodeficiency Syndrome Where can I get more information? Your pharmacist can provide more information about immune globulin intravenous.

See also: Gammar-P I.V. side effects (in more detail)

Privigen IGIV

What is immune globulin intravenous (IVIG)?

Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

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

What is the most important information I should know about immune globulin?

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

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

kidney disease;

diabetes (especially if you use insulin);

a history of stroke or blood clot;

heart disease or high blood pressure;

a condition called paraproteinemia; or

if you are over 65 years old.

How is immune globulin intravenous given?

IVIG should not be injected into a muscle or under the skin.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Throw away any unused medicine that is left over after injecting your dose.

IVIG is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Call your doctor for instructions if you miss a dose of this medication.

urinating less than usual or not at all;

drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

swelling, weight gain, feeling short of breath;

wheezing, chest tightness;

feeling like you might pass out;

fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or

pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Less serious side effects may include:

mild headache;

dizziness;

tired feeling;

back pain, muscle cramps;

minor chest pain; or

flushing (warmth, redness, or tingly feeling).

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 immune globulin?

Immune globulin can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

lithium (Lithobid);

methotrexate (Rheumatrex, Trexall);

medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

More Privigen resources Privigen Side Effects (in more detail) Privigen Use in Pregnancy & Breastfeeding Privigen Drug Interactions Privigen Support Group 0 Reviews for Privigen - Add your own review/rating Compare Privigen with other medications Autoimmune Neutropenia Bone Marrow Transplantation Chronic Lymphocytic Leukemia Evan's Syndrome HIV Infection Idiopathic Thrombocytopenic Purpura Kawasaki Disease Polymyositis/Dermatomyositis Primary Immunodeficiency Syndrome Where can I get more information? Your pharmacist can provide more information about immune globulin intravenous.

See also: Privigen side effects (in more detail)

Privigen IGIV

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