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AFINITOR is prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked.

For Healthcare Professionals For Patients/Caregivers
 
 
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Important Safety Information

Patients should not take AFINITOR® (everolimus) 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 that can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR for a while or use a lower dose. Patients should follow their health care provider's instructions. 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. In some people, 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, 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.

Kidney Failure: Patients taking AFINITOR 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.

Delayed Wound Healing: 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.

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
  • Have other medical conditions
  • Are pregnant or could become pregnant. AFINITOR or AFINITOR DISPERZ can cause harm to your unborn baby. You should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment. Talk to your health care provider about birth control options while taking AFINITOR or AFINITOR DISPERZ
  • Are breastfeeding or plan to breastfeed. You and your health care provider should decide if you will take AFINITOR or breastfeed. You should not do both

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
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • 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: Common side effects 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 gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects include:

  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath
  • Diarrhea and constipation
  • Skin problems (such as rash, acne, dry skin, or itching)
  • Nausea and vomiting
  • Fever
  • Loss of appetite, weight loss
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Abnormal taste or dry mouth
  • Inflammation of the lining of the digestive system
  • Headache
  • Nose bleeds
  • Absence of menstrual periods. You may miss one or more menstrual periods. Tell your health care provider if this happens
  • Pain in arms and legs, mouth and throat, back or joints, or stomach area (abdomen)
  • Low red blood cells, white blood cells, or platelets
  • Increased blood cholesterol levels and certain other blood levels
  • Decreased blood phosphate levels
  • Increased blood sugar levels
  • High blood pressure
  • Difficulty sleeping
  • Hair loss
  • Muscle spasms
  • Feeling dizzy
  • Nail disorders
  • Anxiety, aggression, and other abnormal behaviors
 

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 register marks of their respective owners and are not trademarks or register marks of Novartis.

Indications

AFINITOR 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
  • Adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and cannot be treated with surgery. AFINITOR is not for use in people with carcinoid tumors that actively produce hormones
  • Adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked
  • 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
    • The effectiveness of AFINITOR in treating angiomyolipoma of the kidney is based on a study of patients treated over an average of 8.3 months. More information is needed to understand the long-term effects of treatment with AFINITOR
  • Adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery
    • The effectiveness of AFINITOR is based on change in SEGA size. Improvement in disease-related symptoms or overall survival has not been shown
  • AFINITOR DISPERZ (everolimus tablets for oral suspension) is a prescription medicine used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.

    • The effectiveness of AFINITOR is based on change in SEGA size. Improvement in disease-related symptoms or overall survival has not been shown