Important Safety Information
Patients should not take AFINITOR® (everolimus) Tablets if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their healthcare provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).
AFINITOR can cause serious side effects, which 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 healthcare provider's instructions. Serious side effects include:
Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their healthcare provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.
Infections: AFINITOR may make patients 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 these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their healthcare provider right away if they 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.
Kidney Failure: Patients taking AFINITOR 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 healthcare 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 vaccine, ask your healthcare provider.
- Have other medical conditions
- Are pregnant or could become pregnant. It is not known if AFINITOR will harm your unborn baby. You should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment.
- Are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take AFINITOR or breastfeed. You should not do both.
Tell your healthcare 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 healthcare provider when you get a new medicine. Especially tell your healthcare 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
If you are taking any medicines for the conditions listed above, your healthcare provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your healthcare provider before you start taking any new medicine.
Common Side Effects: Common side effects include mouth ulcers. AFINITOR can cause mouth ulcers and sores. Tell your healthcare provider if you have pain, discomfort, or open sores in your mouth. Your healthcare provider may tell you to use a special mouthwash or gel that does not contain alcohol, peroxide, iodine, or thyme.
Other common side effects include:
- Nausea and vomiting
- Diarrhea and constipation
- Swelling of your hands, arms, legs, and feet
- Joint pain
- Skin problems (such as rash, acne, or dry skin)
- Feeling tired
- Anxiety, aggression, and other abnormal behaviors
- Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your healthcare provider if this happens
- Low red blood cells, white blood cells, or platelets
- Increased blood cholesterol level and certain other blood tests
- Increased blood sugar levels
- Decreased blood phosphate level
Tell your healthcare 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 healthcare 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 accompanying full Prescribing Information for AFINITOR, including Patient Information.
AFINITOR is a prescription medicine used to treat adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex (TSC), when their kidney tumor does not require surgery right away.
The effectiveness of AFINITOR in treating angiomyolipoma of the kidney is based on a study of patients treated over an average of 8.3 months. More information is needed to understand the long-term effects of treatment with AFINITOR.
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