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Understanding Side Effects

AFINITOR® (everolimus) Tablets

What You Can Expect From AFINITOR

It’s common to be concerned about side effects before starting a new treatment. AFINITOR® (everolimus) Tablets may cause some side effects you are not familiar with. That’s why it’s important to learn everything you can so you’re prepared to work closely with your doctor or nurse if a side effect does occur.

The Most Serious Side Effects of AFINITOR

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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. 

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 the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools, 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.

Possible increased risk for a type of allergic reaction called angiodema 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.

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 your 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 these serious side effects, you may need to stop taking AFINITOR for a while or use a lower dose. Always follow your health care provider’s instructions.

Learn About Mouth Sores, the Most Common Side Effect of AFINITOR

Different people react differently to AFINITOR and its possible side effects. It's good to know that you can 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 as early as within 2 weeks of treatment, or they can occur at any time. Stay on the lookout for these signs:

If you develop pain, discomfort, or open sores in your mouth, tell your health care provider. Your health care provider may tell you to re-start this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other Common Side Effects of AFINITOR

Other common side effects of AFINITOR include: 

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

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

 

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.