Understanding Side Effects

AFINITOR® (everolimus) Tablets

MOST SERIOUS SIDE EFFECTS

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 health care 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® (everolimus) Tablets 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 (adults and children), 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 health care 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.

 

Severe allergic reactions. Severe allergic reactions can happen in people who take AFINITOR. 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 a type of allergic reaction called angioedema, in people who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR. Talk with your health care provider before taking AFINITOR 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.

 

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.

 

  • Delayed wound healing. AFINITOR can cause incisions to heal slowly or not heal well. Call your health care provider right away if you have any of the following symptoms: your incision is red, warm or painful; blood, fluid, or pus in your incision; your incision opens up; and/or swelling of your incision
  • Increased blood sugar and fat (cholesterol and triglyceride) levels in the 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
  • Decreased blood cell counts. AFINITOR 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

  

 

COMMON SIDE EFFECTS

The most common side effects of AFINITOR in people who have renal angiomyolipoma:

 

Common side effects include mouth ulcers. AFINITOR can cause mouth ulcers and sores and respiratory tract infections.

 

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. 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.