Important Safety Information
Do not take AFINITOR® (everolimus) Tablets if you have had a severe allergic reaction to everolimus. Talk to your health care provider before taking this medicine if you are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®). Ask your health care provider if you do not know.
AFINITOR can cause serious side effects, including the following:
You may develop lung or breathing problems: In some people, lung or breathing problems may be severe and can 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.
You may be more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections 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 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 swelling, 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: 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 an 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.
Mouth ulcers: AFINITOR can cause mouth ulcers and sores. When you start treatment with AFINITOR, your health care provider may also prescribe a 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 gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.
You may develop kidney failure: In some people, this may be severe and can lead to death. Your health care provider should do tests to check your kidney function before and during your 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 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.
Worsening side effects from radiation treatment can sometimes be severe. Tell your health care provider if you have had or are planning to receive radiation therapy.
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 immunization or vaccine received, ask your health care provider. For children with TSC and SEGA, or certain types of seizures, work with your health care provider to complete the recommended childhood series of vaccines before your child starts treatment with AFINITOR
- Are pregnant, or could become pregnant, or have a partner who could become pregnant. AFINITOR can cause harm to your unborn baby. For females who are able to become pregnant, your health care provider will give you a pregnancy test before you start treatment with AFINITOR. You should use effective birth control during treatment and for 8 weeks after your last dose of AFINITOR or AFINITOR DISPERZ. Males with a female partner should use effective birth control during treatment and for 4 weeks after your last dose of AFINITOR or AFINITOR DISPERZ
- 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
- Have received radiation therapy or are planning to receive radiation therapy in the future
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 the following:
- St John’s wort (Hypericum perforatum)
- Medicine for:
- Fungal infections
- Bacterial infections
- Heart conditions or high blood pressure
- Medicines that weaken the immune system (your body’s ability to fight infections and other diseases)
Ask your health care provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. 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.
You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR. It may make the amount of AFINITOR in your blood increase to a harmful level.
The most common side effect of AFINITOR in people who have renal angiomyolipoma is respiratory tract infection.
Other side effects that may occur with AFINITOR:
- Absence of menstrual periods (menstruation). You may miss 1 or more menstrual period. 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.
The brands listed are the trademarks or registered trademarks of their respective owners.
AFINITOR 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.
It is not known if AFINITOR is safe and effective in children to treat kidney tumors called angiomyolipoma, which can happen in children with TSC.