Side Effects of AFINITOR
AFINITOR can cause serious side effects. These serious side effects include:
1. You may develop lung or breathing problems. 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
2. 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, have chills, or do not feel well.
Symptoms of hepatitis B or infection may include the following:
- Skin rash
- Joint pain and inflammation
- Loss of appetite
- Pale stools or dark urine
- Yellowing of the skin
- Pain in the upper right side of the stomach
3. You may have an allergic reaction called 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. You should get medical help right away if you have trouble breathing or develop swelling of the tongue, mouth, or throat during treatment with AFINITOR.
4. You may develop kidney failure. 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.
5. 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.
Common side effects of AFINITOR in patients who have angiomyolipoma with TSC include:
- Mouth ulcers. AFINITOR can cause mouth ulcers and sores. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme.
- Nausea and vomiting
- Diarrhea and constipation
- Swelling of your hands, arms, legs, and feet
- Joint pain
- Skin problems (such as rash, acne, or dry skin)
- Feeling tired
- Anxiety, aggression, and other abnormal behaviors
- Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your health care provider if this happens.
- Low red blood cells, white blood cells or platelets
- Increased blood cholesterol level and certain other blood levels
- Increased blood sugar levels
- Decreased blood phosphate level
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.
A NONSURGICAL TREATMENT FOR AML ASSOCIATED WITH TSC
AFINITOR® (everolimus) Tablets is a prescription medicine used to treat adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex (TSC), when their kidney tumor does not require surgery right away.
Important Safety Information
AFINITOR can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can lead to death. 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. AFINITOR can cause incisions to heal slowly or not heal well. Mouth ulcers and mouth sores are common side effects, occurring in up to 78% of patients taking AFINITOR. AFINITOR can affect blood cell counts, kidney and liver function, and blood sugar and cholesterol levels. Regular blood tests should be performed before starting AFINITOR and as needed during treatment to check blood cell count, kidney and liver function, blood sugar and cholesterol levels. For SEGA patients, blood tests to see how much AFINITOR is in the blood should also be performed.
Please see additional
Important Safety Information.
Please see full Prescribing Information for AFINITOR, including Patient Information.