AFINITOR is an mTOR inhibitor
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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.
- Risk of wound healing problems. Wounds may not heal properly during treatment with AFINITOR. Tell your health care provider if you plan to have any surgery before starting or during treatment with AFINITOR. You should stop taking AFINITOR at least 1 week before planned surgery. Your health care provider should tell you when you may start taking AFINITOR again after surgery
- Increased blood sugar and fat (cholesterol and triglyceride) levels in 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.
Find answers to common questions about AFINITOR and its use in treating TSC‑associated renal angiomyolipoma