Product Details

What you need to know before you take Rapamune

Do not take Rapamune: – if you are allergic to sirolimus or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking 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 and may result in your having additional blood tests. Page 2 of 7 − Rapamune, like other 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. − If you have a body mass index (BMI) greater than 30 kg/m2 , you may be at increased risk of abnormal wound healing. − If you are considered to be at high risk for kidney rejection, such as if you had a previous transplant that was lost to rejection. 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 treatment with Rapamune. Exposure to sunlight and UV light should be limited by covering your skin with clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer. Children and adolescents There is limited experience on the use of Rapamune in children and adolescents less than 18 years of age. The use of Rapamune is not recommended in this population. Other medicines and Rapamune Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can interfere with the action of Rapamune and, therefore, dose adjustment of Rapamune may be required. In particular, you should inform your doctor or pharmacist if you are taking any of the following: − any other immunosuppressant medicines. − antibiotics or antifungal medicines used to treat infection e.g. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole. It is not recommended that Rapamune be taken with rifampicin, ketoconazole or voriconazole. − any 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 Parkinson’s disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (e.g., for HIV and hepatitis C such as ritonavir, indinavir, boceprevir, and telaprevir). − St. John’s Wort (Hypericum perforatum). − letermovir (an antiviral medicine to prevent getting ill from cytomegalovirus). The use of live vaccines should be avoided with the use of Rapamune. Before vaccinations, please inform your doctor or pharmacist that you are receiving Rapamune. The use of Rapamune may lead to increased levels of cholesterol and triglycerides (blood fats) in your blood 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 medicines to lower your blood fats. The combined use of Rapamune with angiotensin-converting enzyme (ACE) inhibitors (a type of medicine used to lower blood pressure) may result in allergic reactions. Please inform your doctor if you are taking any of these medicines. Rapamune with food and drink Page 3 of 7 Rapamune should be taken consistently, either with or without food. If you prefer to take Rapamune with food, then you should always take it with food. If you prefer to take Rapamune without food, then you should always take it without food. Food can affect the amount of medicine that gets into your bloodstream, and taking your medicine in a consistent way means that the blood levels of Rapamune remain more stable. Rapamune should not be taken with grapefruit juice. Pregnancy, breast-feeding and fertility Rapamune should not be used during pregnancy unless clearly necessary. You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not known whether Rapamune passes into breast milk. Patients taking Rapamune should discontinue breast-feeding. Decreased sperm count has been associated with the use of Rapamune and usually returns to normal once treatment is stopped. Driving and using machines Although Rapamune treatment is not expected to affect your ability to drive, if you have any concerns please consult your doctor. Rapamune contains lactose and sucrose Rapamune contains 86.4 mg of lactose and up to 215.8 mg of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.