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Important Safety Information

AFINITOR® (everolimus) Tablets can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can lead to death. Mouth ulcers and mouth sores are common side effects, occurring in up to 86% of patients taking AFINITOR. AFINITOR can affect blood cell counts, kidney and liver function, and blood sugar and cholesterol levels. Regular blood tests should be performed before starting AFINITOR and as needed during treatment to check blood cell count, kidney and liver function, and blood sugar and cholesterol levels.

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Important Safety Information.


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:

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
  • Tuberculosis
  • Seizures
  • 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:

  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath
  • Diarrhea and constipation
  • Rash, dry skin, and itching
  • Nausea and vomiting
  • Fever
  • Loss of appetite, weight loss
  • Swelling of arms, hands, feet, ankles, face or other parts of the body
  • Abnormal taste
  • Dry mouth
  • Inflammation of the lining of the digestive system
  • Headache
  • Nose bleeds
  • Pain in arms and legs, mouth and throat, back or joints
  • High blood glucose
  • High blood pressure
  • Difficulty sleeping
  • Hair loss
  • Muscle spasms
  • Feeling dizzy
  • Nail disorders

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 or call 1-800-FDA-1088.

Please see the 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 register marks of Novartis.


Advanced Pancreatic Neuroendocrine Tumors (PNET)

AFINITOR is a prescription medicine used to treat adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and cannot be treated with surgery. It is not known if AFINITOR is safe and effective in people with carcinoid tumors.