Patients should not take AFINITOR if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).
AFINITOR can cause serious side effects that can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR for a while or use a lower dose. Patients should follow their health care provider’s instructions. Please be aware of the following:
You may develop lung or breathing problems. In some people, lung or breathing problems may be severe and can even lead to death. Tell your health care provider right away if you have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.
You may be more likely to develop an infection such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people (including adults and children), these infections may be severe and can even lead to death. You may need to be treated as soon as possible. You should tell your health care provider right away if you have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.
Severe allergic reactions. Severe allergic reactions can happen in people who take AFINITOR. Call your health care provider or get medical help right away if you get signs and symptoms of a severe allergic reaction including: rash, itching, hives, flushing, trouble breathing or swallowing, chest pain, or dizziness.
Possible increased risk for a type of allergic reaction called angioedema, in people who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR. Talk with your health care provider before taking AFINITOR if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR.
You may develop kidney failure. In some people, this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR.
Before taking AFINITOR, tell your health care provider about all your medical conditions, including if you:
- Have or have had kidney problems
- Have or have had liver problems
- Have diabetes or high blood sugar
- Have high blood cholesterol levels
- Have any infections
- Previously had hepatitis B
- Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR. If you are not sure about the type of immunization or vaccine received, ask your health care provider. For children with TSC and SEGA, or certain types of seizures, work with your health care provider to complete the recommended childhood series of vaccines before your child starts treatment with AFINITOR
- Are pregnant, or could become pregnant, or have a partner who could become pregnant. AFINITOR can cause harm to your unborn baby. If you are a woman who is able to become pregnant, you should use effective birth control while using AFINITOR and for 8 weeks after your last dose. If you are a male with a woman partner, you should use effective birth control during treatment and for 4 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR
- Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose
- Are about to have surgery, if you have had a recent surgery, or if you have an unhealed wound
Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John’s wort (Hypericum perforatum), medicines that weaken your immune system (your body’s ability to fight infections and other problems), or medicines for:
- Fungal infections
- Bacterial infections
- Heart conditions or high blood pressure
Ask your health care provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your health care provider before you start taking any new medicine.
You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR. It may make the amount of AFINITOR in your blood increase to a harmful level.
Possible Side Effects of AFINITOR:
AFINITOR can cause serious side effects.
- Delayed wound healing. AFINITOR can cause incisions to heal slowly or not heal well. Call your health care provider right away if you have any of the following symptoms: your incision is red, warm or painful; blood, fluid, or pus in your incision; your incision opens up; and/or swelling of your incision
- Increased blood sugar and fat (cholesterol and triglyceride) levels in the blood. Your health care provider should do blood tests to check your fasting blood sugar, cholesterol, and triglyceride levels in your blood before you start and during treatment with AFINITOR
- Decreased blood cell counts. AFINITOR can cause you to have decreased red blood cells, white blood cells, and platelets. Your health care provider should do blood tests to check your blood cell counts before you start and during treatment with AFINITOR
The most common side effects of AFINITOR in people who have renal angiomyolipoma:
- Mouth ulcers: AFINITOR can cause mouth ulcers and sores. When you start treatment with AFINITOR, your health care provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your health care provider’s instructions on how to use this prescription mouthwash. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to restart this mouthwash or to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme
- Respiratory tract infection
Other side effects that may occur with AFINITOR:
- Absence of menstrual periods (menstruation). Women may miss 1 or more menstrual periods. Tell your health care provider if this happens
- Fertility may be affected in women and may affect the ability to become pregnant. Talk to your health care provider if this is a concern for you
- Fertility may be affected in men and may affect the ability to father a child. Talk to your health care provider if this is a concern for you
Tell your health care provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of AFINITOR. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information for AFINITOR, including Patient Information.
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