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Understanding Side Effects

AFINITOR

What Are the Possible Side Effects of AFINITOR When Treating My Progressive Lung NET?

It is important to tell your doctor as soon as possible about any side effects you have while taking AFINITOR® (everolimus) Tablets for progressive lung neuroendocrine tumors (lung NET).

 

AFINITOR can cause serious side effects that include the following:

In some people 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

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 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 the following:

  • 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

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.

In people who take an angiotensin-converting enzyme (ACE) inhibitor, a type of blood pressure medication, during treatment with AFINITOR® (everolimus) Tablets. 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.

In some people this may be severe and can even lead to death. Your health care provider should do tests to check your kidney function before and during your treatment with AFINITOR.

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.

Your health care provider should do blood tests to check your fasting blood sugar, cholesterol, and triglyceride levels in the blood before you start and during treatment with AFINITOR.

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.

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.

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.

Learn About Mouth Sores, the Most Common Side Effect of AFINITOR When Used for Your Progressive Lung NET

Different people react differently to AFINITOR and its possible side effects. It's good to know that your doctor can help you take a proactive role in managing a common side effect called stomatitis, or mouth ulcers and sores.

 

Mouth sores can cause oral pain, redness, and changes in taste. They can sometimes be severe and can appear within the first 8 weeks of treatment, or they can occur at any time. Stay on the lookout for these signs:

 

AFINITOR and Mouth Sores or Ulcers

 

Other common side effects of AFINITOR include the following:

 

  • Infections
  • Rash
  • Feeling weak or tired
  • Diarrhea
  • Swelling of arms, hands, feet, ankles, face or other parts of the body
  • Stomach-area (abdominal) pain
  • Nausea
  • Fever
  • Cough
  • Headache
  • Decreased appetite

 

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.