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Understanding Side Effects

AFINITOR® (everolimus) Tablets

Understanding Possible Side Effects of AFINITOR

It is important to tell your health care provider as soon as possible about any side effects you have while taking AFINITOR® (everolimus) Tablets.

AFINITOR can cause serious side effects that include the following:

You may develop lung or breathing problems. In some patients, 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 these infections may be severe and can even lead to death. You may need to be treated as soon as possible.

Tell your health care provider right away if you have a temperature of 100.5°F or above, have chills, or do not feel well.

Symptoms of hepatitis B or infection may include:

  • Fever
  • Chills
  • Skin rash
  • Joint pain and inflammation
  • Tiredness
  • Loss of appetite
  • Nausea
  • Pale stools or dark urine
  • Yellowing of the skin
  • Pain in the upper right side of the stomach

If you take an ACE inhibitor medicine during treatment with AFINITOR, you are at a possible increased risk for a type of an allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR if you are not sure if you take an angiotensin-converting enzyme (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.

If you have any of the serious side effects listed above, you may need to stop taking AFINITOR for a while or use a lower dose. Follow your health care provider's instructions.

Common AFINITOR Side Effects

Common side effects of AFINITOR in people with advanced PNET include:

  • Mouth ulcers. AFINITOR can cause mouth ulcers and sores. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme
  • 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

Other side effects that may occur with AFINITOR:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens.
  • AFINITOR may affect fertility in females and males, and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. 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.

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.