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Understanding Side Effects

AFINITOR

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AFINITOR® (everolimus) Tablets may cause side effects in some individuals and every patient's experience with AFINITOR will be different. Some people will experience more side effects than other people. Remember to talk to your doctor about any side effects that may appear so that together you can work to find a way to try to manage them.

  • You may develop lung or breathing problems. In some people, lung or breathing problems may be severe and can even lead to death. You may need to stop AFINITOR for a while or use a lower dose. 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, 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, 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

 

  • You may develop angioedema. Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR are at a possible increased risk for a type of allergic reaction called angioedema. 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. Your doctor should do tests to check your kidney function before and during your treatment with AFINITOR.

 

  • You may have delayed wound healing. AFINITOR can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; you have blood, fluid, or pus in your incision; your incision opens up; or you have swelling of your incision.

 

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.

Some of the most common side effects of AFINITOR in people with advanced renal cell carcinoma 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 mouth gel that does not contain alcohol, 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
  • Pains 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.