Patients should not take AFINITOR® (everolimus) 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, have 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:
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:
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:
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 full Prescribing Information for AFINITOR including Patient Information.
The brands listed are the trademarks or registered trademarks of their respective owners and are not trademarks or registered trademarks of Novartis.
AFINITOR is a prescription medicine used to treat:
AFINITOR DISPERZ (everolimus tablets for oral suspension) is a prescription medicine used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.