AFINITOR® (everolimus) Tablets is a prescription medicine used to treat advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer.
Important Safety Information
Patients should not take AFINITOR if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).
AFINITOR can cause serious side effects, some of which can be severe and can even lead to death. Your health care team may have ways to help manage side effects that do occur. It’s important to talk with your doctor or nurse about side effects you experience and the best ways to manage them. 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 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. 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, 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, 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.
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.
Kidney Failure: Patients taking AFINITOR may develop kidney failure. 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.
Before taking AFINITOR, tell your health care provider about all your medical conditions, including if you:
- Have or have had kidney problems
- Have or have had liver problems
- Have diabetes or high blood sugar
- Have high blood cholesterol levels
- Have any infections
- Previously had hepatitis B
- Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR. If you are not sure about the type of vaccine, ask your health care provider
- Are pregnant, could become pregnant, or have a partner who could become pregnant. AFINITOR can cause harm to your unborn baby. If you are a woman who is able to become pregnant, you should use effective birth control while using AFINITOR and for 8 weeks after your last dose. If you are a male with a woman partner, you should use effective birth control during treatment and for 4 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR
- Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose
- Are planning to have surgery or if you have had a recent surgery. You should stop taking AFINITOR at least 1 week before planned surgery
Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR with certain other medicines can cause serious side effects. Keep a list of medicines you take, and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John’s wort (Hypericum perforatum), medicines that weaken your immune system (your body’s ability to fight infections and other problems), or medicines for:
- Fungal infections
- Bacterial infections
- Heart conditions or high blood pressure
If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your health care provider before you start taking any new medicine.
Common Side Effects:
The most common side effect of AFINITOR is 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 mouth gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.
Other common side effects of AFINITOR include:
- Feeling weak or tired
- Swelling of arms, hands, feet, ankles, face or other parts of the body
- Stomach-area (abdominal) pain
- 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. 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.
Please see full Prescribing Information for AFINITOR, including Patient Information.
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