Understanding Side Effects

AFINITOR Tablets and AFINITOR DISPERZ 

THE MOST SERIOUS SIDE EFFECTS

AFINITOR® (everolimus) Tablets and AFINITOR DISPERZ® (everolimus tablets for oral suspension) can cause serious side effects. These serious side effects include:

 

  • You may develop lung or breathing problems: In some people, lung or breathing problems may be severe and can 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 active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people (including adults and children), these infections may be severe and can 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, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, have chills, skin rash, joint pain and swelling, 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: 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 an allergic reaction called angioedema in people who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ. Talk with your health care provider before taking AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ.

 

  • Mouth ulcers and sores: Mouth ulcers and sores are common during treatment with AFINITOR or AFINITOR DISPERZ and can be severe. When you start treatment with AFINITOR or AFINITOR DISPERZ, your health care provider may also prescribe a 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. If you develop pain, discomfort, or open sores in your mouth, tell your health care provider. Your health care provider may tell you to restart this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme.

  • You may develop kidney failure: In some people, this may be severe and can lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR or AFINITOR DISPERZ.

 

  • Risk of wound healing problems: Wounds may not heal properly during treatment with AFINITOR or AFINITOR DISPERZ. Tell your health care provider if you plan to have any surgery before starting or during treatment with AFINITOR or AFINITOR DISPERZ. You should stop taking AFINITOR or AFINITOR DISPERZ at least 1 week before planned surgery. Your health care provider should tell you when you may start taking AFINITOR or AFINITOR DISPERZ after surgery.

 

  • Increased blood sugar and fat (cholesterol and triglyceride) levels in 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 or AFINITOR DISPERZ.

 

  • Decreased blood cell counts: AFINITOR and AFINITOR DISPERZ 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 or AFINITOR DISPERZ.

 

  • Worsening side effects from radiation treatment can sometimes be severe. Tell your health care provider if you have had or are planning to receive radiation therapy.

 

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

COMMON SIDE EFFECTS

Common side effects include mouth ulcers and respiratory tract infection. AFINITOR or AFINITOR DISPERZ can cause mouth ulcers and sores. Your doctor may refer to this as stomatitis.

 

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

 

Other side effects that may occur with AFINITOR or AFINITOR DISPERZ:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual period. Tell your health care provider if this happens
  • AFINITOR or AFINITOR DISPERZ 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 or AFINITOR DISPERZ. 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-1088blobid0.png.