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Understanding Side Effects

AFINITOR

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AFINITOR® (everolimus) Tablets can cause side effects in some individuals, and every patient's experience with AFINITOR will be different. Some people will experience more serious 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 patients, lung or breathing problems may be severe and can even lead to death. Consult with your health care provider before stopping, interrupting, or lowering your dose of AFINITOR. 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 patients who have had hepatitis B in the past. In some patients, 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; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

 

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 kidney cancer include:

  • Mouth ulcers: AFINITOR can cause mouth ulcers and sores. When you start treatment with AFINITOR, your health care provider may tell you to also start a prescription 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. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to restart this mouthwash or to use a special mouthwash or gel that does not contain alcohol, peroxide, iodine, or thyme
  • Infections
  • Diarrhea
  • Swelling of the arms, hands, feet, or ankles, or other parts of the body
  • Feeling weak or tired
  • Rash, dry skin, and itching
  • Cough, shortness of breath
  • Nausea
  • Fever
  • Weight loss or loss of appetite
  • Vomiting
  • Abnormal taste
  • Nose bleeds
  • High blood glucose

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 or call 1-888-669-6682.