About Everolimus

 

Healthcare providers, such as doctors and pharmacists, often refer to AFINITOR as everolimus. This is just the generic name for the same medicine.

Everolimus is part of a class of drugs called mTOR (mammalian target of rapamycin) inhibitors. It may slow the growth and spread of kidney cancer and pancreatic neuroendocrine tumors, and may reduce the size of SEGA brain tumors that are seen with tuberous sclerosis complex (TSC).1

What does AFINITOR treat?

AFINITOR® (everolimus) is Food and Drug Administration (FDA)-approved to treat:

Reference

1. AFINITOR [prescribing information]. East Hanover, NJ; Novartis Pharmaceuticals Corp; August 2012.

 
 

Important Safety Information

AFINITOR can cause serious side effects, including lung or breathing problems, infections, and kidney failure, which can lead to death. Mouth ulcers and mouth sores are common side effects, occurring in up to 86% 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, and 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.

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. It is not known if AFINITOR is safe and effective in people with carcinoid tumors
  • 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 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
 
 

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 healthcare provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).

AFINITOR can cause serious side effects, which 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 healthcare 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 healthcare 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 healthcare 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.

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

Tell your healthcare 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 healthcare provider when you get a new medicine. Especially tell your healthcare 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 healthcare provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. Tell your healthcare 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 healthcare provider if you have pain, discomfort, or open sores in your mouth. Your healthcare provider may tell you to use a special mouthwash or gel that does not contain alcohol, 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 healthcare 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 level and certain other blood tests
  • Decreased blood phosphate level
  • 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 healthcare 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 healthcare 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 and are not trademarks or registered trademarks 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. It is not known if AFINITOR is safe and effective in people with carcinoid tumors
  • 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