Rapamune 1mg / ml Oral Solution


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Rapamune 1mg / ml Oral Solution


Rapamune 1mg/ml oral solution.


Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any other effects not mentioned in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What Rapamune is and what it is used for
2. Before you take Rapamune
3. How to take Rapamune
4. Possible side effects
5. How to store Rapamune
6. Further information

What Rapamune Is And What It Is Used For

Rapamune belongs to a group of medicines called immunosuppressants. It helps to control your body’s immune system after you have received an organ transplant. It is used to prevent your body from rejecting transplanted kidneys and is normally used with medicines called corticosteroids and initially with ciclosporin.

Before You Take Rapamune Do not take Rapamune if you are allergic (hypersensitive) to sirolimus or any of the other ingredients of Rapamune. Take special care with Rapamune if you have any liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive. immunosuppressive medicines may decrease your body’s ability to fight infection, and may increase the risk of developing cancer of the lymphoid tissues and skin.

Your doctor will perform tests to monitor the levels of Rapamune in your blood. Your doctor will also perform tests to monitor your kidney function, your blood fat (cholesterol and/or triglycerides) levels and, possibly, your liver function, during therapy with Rapamune.

Exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including those obtained without a prescription. Some medicines can interfere with the action of Rapamune. In particular, you should inform your doctor or pharmacist if you are taking any of the following:

any other immunosuppressive agents excluding ciclosporin or corticosteroids. antibiotics or antifungal medicines used to treat infection e.g. rifampicin, clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole, ketoconazole and voriconazole. high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem. anti-epileptic medicines including carbamazepine, phenobarbital, phenytoin. medicines used to treat-ulcers or other gastrointestinal disorders such as cisapride, cimetidine, metoclopramide. bromocriptine (used in the treatment of Parkinsons’ disease and various hormonal disorders), danazol (used in the treament of gynaecological disorders), or protease inhibitors (used in the treatment of HIV). St. John’s Wort (Hypericum perforatum).

The use of Rapamune may lead to increased blood concentrations of cholesterol and triglycerides that may require treatment. Medicines known as “statins” and “fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis). Please inform your doctor if you are taking drugs to lower your blood fats.

Taking Rapamune with food and drink

Rapamune should be taken consistently, either with or without food. Rapamune should be diluted only with water or orange juice. Do not take Rapamune with grapefruit juice.

Pregnancy and breast feeding

You must use effective contraception methods during treatment with Rapamune and for 12 weeks after treatment has stopped. If you are unsure, or think you may have become pregnant, talk to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Decreased sperm count has been associated with the use of Rapamune and usually resolves after discontinuation.

It is not known whether Rapamune passes into breast milk. Patients taking Rapamune should discontinue breast-feeding.

Use in children and adolescents

There is limited experience with the administration of Rapamune in children and adolescents.

Driving and using machines

No specific studies on the effects of Rapamune on the ability to drive and use machines have been conducted. Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor.

Important information about one of the ingredients of Rapamune

WARNING: This medicine contains 1.5% to 2.5% ethanol. Each 2 mg dose contains up to 50 mg of alcohol. Alcohol may be harmful for those suffering from alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. Alcohol may modify or increase the effect of other medicines.

How To Take Rapamune

Rapamune is for oral use only. Always take Rapamune exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide exactly what dose of Rapamune you must take and how often to take it. Follow your doctor’s instructions exactly and never change the dose yourself. Do not stop taking your medicine unless your doctor tells you to. If you stop taking your medicine, you risk losing your transplant.

Usually for an adult your doctor will give you an initial dose of 6 mg as soon as possible after the kidney transplant operation. Then you will need to take 2 mg of Rapamune each day, unless otherwise directed by your doctor. Your dose will be adjusted depending on the level of Rapamune in your blood. Your doctor will need to perform a blood test to measure Rapamune concentrations.

If you are also taking ciclosporin, then you must take the two medicines approximately 4 hours apart.

Instructions on how to dilute Rapamune

1. Remove the safety cap from the bottle by squeezing the tabs on the cap and twisting. Insert the syringe adapter into the bottle until it is flush with the top of the bottle. Do not attempt to remove the syringe adapter from the bottle once inserted.

2. With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter.

3. Withdraw the exact amount of Rapamune oral solution as prescribed by your doctor by gently pulling out the plunger of the dosing syringe until the bottom of the black line of the plunger is level with the appropriate mark on the dosing syringe. The bottle should remain in an upright position when withdrawing the solution. If bubbles form in the dosing syringe during withdrawal, empty the Rapamune solution back into the bottle and repeat the withdrawal procedure.

4. You may have been instructed to take your Rapamune oral solution at a particular time of day. If it is necessary to carry your medication with you, fill the dosing syringe to the appropriate mark and place a cap securely on it – the cap should snap into place. Then place the capped dosing syringe in the carrying case provided. Once in the syringe the medication may be kept at room temperature (not exceeding 25°C) or refrigerated and should be used within 24 hours.

Empty the contents of the dosing syringe into only a glass or plastic container holding at least 60 ml of water or orange juice. Stir well for one minute and drink immediately. Refill the glass with at least 120 ml of water or orange juice, stir well, and drink immediately. No other liquids, including grapefruit juice, should be used for dilution. The dosing syringe and cap are to be used once and then discarded.

When refrigerated the solution in the bottle may develop a slight haze. If this occurs, simply bring your Rapamune 1 mg/1 ml oral solution to room temperature and shake gently. The presence of this haze does not affect the quality of Rapamune.

If you take more Rapamune than you should

If you have taken more medicine than you were told contact a doctor or go to the nearest hospital emergency department straight away. Always take the labelled medicine bottle with you, even if it is empty.

If you forget to take Rapamune

If you forget to take Rapamune, take it as soon as you remember, but not within 4 hours of the next dose of ciclosporin. After that, continue to take your medicines as usual. Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart. If you miss a dose of Rapamune completely, you should inform your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Rapamune can cause side effects, although not everybody gets them. However, since Rapamune is taken in combination with other medicines, the side effects cannot always be attributed with absolute certainty to Rapamune. When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts with or without rash (thrombocytopenic purpura/haemolytic uraemic syndrome).

Immunosuppressants, including Rapamune, reduce your body’s own defence mechanisms to stop you rejecting your transplanted organ. Consequently your body will not be as good as normal at fighting infections. So if you are taking Rapamune you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.

Possible side effects of Rapamune are listed according to the following categories:

Very common: more than 1 per 10

Common: less than 1 per 10 but more than 1 per 100

Uncommon: less than 1 per 100 but more than 1 per 1000

Rare: less than 1 per 1000

Body as a whole:

Very common: Fluid collection around the kidney, swelling of the extremities, fever, pain

Common: Impaired healing (this may include separation of the layers of a surgical wound or suture line), swelling, infections (including life-threatening infections)

Nervous system disorders:

Very common: Headache

Cardiac disorders:

Common: Rapid heart rate

Uncommon: Fluid collection in the sac around the heart that, in some cases, may decrease the heart's ability to pump blood

Blood vessel disorders:

Very common: Increased blood pressure

Common: Blood clots in the legs

Uncommon: Blood clots in the lung

Gastrointestinal reactions

Very common: Abdominal pain, diarrhea, constipation, nausea

Common: Mouth sores, fluid collection in the abdomen

Uncommon: Inflammation of the pancreas

Blood and lymph disorders:

Very common: Low red blood cells, low blood platelets

Common: Kidney damage with low blood platelets and low red blood cell counts with or without rash (thrombocytopenic purpura/haemolytic uraemic syndrome), a reduced number of infection fighting cells in the blood (white blood cells), low levels of a type of white blood cells called neutrophils

Uncommon: Cancer of the lymph tissue (lymphoma/post-transplant lympho-proliferative disorder), combined lowering of red blood cells, white blood cells and blood platelets

Rare: Too much fluid collecting in the tissues due to irregular lymph function

Immune system disorders:

Rare: Allergic reactions including those that are life-threatening

Metabolism and nutrition disorders:

Very common: Elevated cholesterol, elevated blood sugar, elevated fat in the blood, low blood potassium, low blood phosphorus, elevated lactate dehydrogenase protein in the blood, elevated creatinine in the blood

Common: Diabetes, abnormal tests of liver function, elevated AST and/or ALT liver enzymes

Bone and joint disorders:

Very common: Joint pain

Common: Deterioration of bone

Respiratory tract disorders:

Common: Pneumonia and other causes of inflammation that may lead to lung damage, fluid around the lung, nose bleeds

Uncommon: Bleeding from the lung.

Rare: Protein build-up in the air sacs of the lungs that may interfere with breathing

Skin disorders:

Very common: Acne

Common: Skin cancer, rash

Kidney disorders:

Very common: Urinary tract infection

Common: Kidney infection; protein in the urine

Uncommon: Protein in the urine, occasionally severe and associated with side effects such as swelling

There is a general tendency for fluid to collect in various tissues.

Serious liver damage has also been reported.

Scarring in the kidney that may reduce kidney function has been reported.

The above side effects may require medical intervention and some may be life-threatening or fatal.

You should see your doctor immediately if you experience symptoms such as swollen face, tongue and/or pharynx (back of the mouth) and/or difficulties in breathing (angioedema), or a skin condition whereby the skin can peel off (exfoliative dermatitis). If you are concerned about any side effect or if you notice any other effects not mentioned in this leaflet, please inform your doctor or pharmacist.

How To Store Rapamune

Keep out of the reach and sight of children.

Do not use Rapamune after the expiry date which is stated on the carton after EXP:. The expiry date refers to the last day of that month.

Keep Rapamune oral solution in its original bottle in order to protect from light. Store in a refrigerator (2°C - 8°C). Once the bottle has been opened, the contents should be kept refrigerated and used within 30 days. If necessary, you may store the bottles at room temperature up to 25°C for a short period of time (no longer than 24 hours).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Rapamune contains

The active substance is sirolimus. Each ml of Rapamune contains 1 mg of sirolimus.

The other ingredients are:

Polysorbate 80 and phosal 50 PG (phosphatidylcholine, propylene glycol, monodiglycerides, ethanol (1.5% to 2.5%), soya fatty acids, and ascorbyl palmitate).

What Rapamune looks like and contents of the pack

Rapamune oral solution is supplied in 60 ml amber glass bottles.

Marketing authorisation holder: Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Manufacturer: Wyeth Medica Ireland Little Connell Newbridge Co. Kildare Ireland


Wyeth Pharmaceuticals New Lane Havant Hampshire PO9 2NG United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Wyeth Pharmaceuticals Tel:+44 1628 415330 Fax:+44 1628 414802

This leaflet was last approved in: 07/2010

Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.emea.europa.eu

Doc ID 61545 (Clean version of 61544)

Rapamune 1mg ml Oral Solution

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