Who Is Afinitor Right for?

Afinitor is for use in patients with subependymal giant cell astrocytoma (SEGA) associated with Tuberous Sclerosis (TS) who need treatment but are not candidates for curative surgery. The efficacy of Afinitor is based on change in SEGA size. Improvement in disease-related symptoms or increase in survival has not been shown.

Before Afinitor, there have been no FDA-approved therapies to treat SEGAs associated with TS. For SEGA patients in whom curative surgery is not possible, Afinitor is a therapeutic option. The efficacy of Afinitor is based on change in SEGA size. It's important to note that clinical benefits, like improvement in disease-related symptoms or increase in overall survival have not been shown.

It is not known if Afinitor is safe and effective in children under 3 years of age with SEGA.

Tuberous Sclerosis is a genetic disease that causes nonmalignant tumors to form in many organs, including the brain. SEGAs are benign tumors that form in the brains of about 5% to 20% of TS patients.

Afinitor is available by prescription only.

Afinitor should not be used by patients who are:

  • Allergic to Afinitor or any of its ingredients. Talk to your doctor before taking Afinitor if you are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®)*
  • Pregnant, as it is not known if Afinitor will harm your unborn baby. You should use effective birth control while taking Afinitor and for 8 weeks after stopping treatment

Tell your doctor:

  • About all of your medical conditions, including if you have or have had kidney problems, liver problems, diabetes or high blood sugar, high cholesterol levels, infections, or hepatitis B
  • If you are pregnant or could become pregnant
  • If you are breastfeeding or plan to breastfeed. It is not known if Afinitor passes into your breast milk. You and your doctor should decide if you will take Afinitor or breastfeed. You should not do both
  • About all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements such as St. John's Wort and medicines for fungal infections, bacterial infections, tuberculosis, seizures, HIV/AIDS, heart conditions, high blood pressure, and medicines that suppress your immune system. Do not drink grapefruit juice, or eat grapefruit, during your treatment with Afinitor. You should tell your doctor before you start taking any new medicine
  • If you are scheduled to receive any vaccines. You should not receive a live vaccine or be around people who have recently received a live vaccine
  • If you have any side effect that bothers you or does not go away. Afinitor can cause serious side effects. Common side effects of Afinitor include infections of the respiratory tract, sinuses and ears; mouth ulcers; diarrhea and constipation; vomiting; stomach pain; fever; seizure; headache; dizziness; skin problems (such as rash, acne, dry skin, or scratching of the skin); cough; stuffy or runny nose; change in personality; low white blood cells (a type of blood cell that fights infections; your doctor will periodically check), and high levels of fats in the blood (raised triglycerides). These are not all the possible side effects of Afinitor. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Talk to your doctor to find out if Afinitor is the right treatment option for you or someone you care about.

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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 86% of SEGA 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 levels and how much AFINITOR is in their blood.

Please click here for additional Important Safety Information.

AFINITOR is used to treat people with subependymal giant cell astrocytoma (SEGA), a brain tumor seen with a genetic condition called tuberous sclerosis (TS), who need treatment but are not candidates for curative surgery.

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

AFINITOR is available by prescription only.

Important Safety Information

Patients should not take AFINITOR 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 including lung or breathing problems, infections and kidney failure, 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.

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, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stool or dark urine, yellowing of the skin, or pain in the upper right side.

Kidney Failure: AFINITOR may cause 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.

Mouth ulcers: AFINITOR can cause mouth ulcers and sores. In patients taking AFINITOR for SEGAs, 86% of patients developed mouth ulcers/sores. Patients should tell their healthcare provider if they have pain, discomfort, or open sores in their mouth. Their healthcare provider may tell them to use a special mouthwash or mouth gel that does not contain alcohol or peroxide.

Blood tests: Patients will have regular blood tests before they start AFINITOR and as needed during their treatment. These will include tests to check the patient's blood cell count, kidney and liver function, blood sugar levels, and how much AFINITOR is in their blood to help the doctor decide how much AFINITOR they need to take.

Other medicines/food and AFINITOR: AFINITOR may affect the way other medicines work, and other medicines can affect how AFINITOR works. Using AFINITOR with other medicines can cause serious side effects. Patients should tell their healthcare provider about all of the medicines they take, including prescription and non-prescription medicines, vitamins, and herbal supplements such as: St. John's Wort and medicine for seizures, fungal infections, bacterial infections, tuberculosis, HIV/AIDS, heart conditions or high blood pressure, and medicines that suppress their immune system. Patients should not drink grapefruit juice or eat grapefruit during their treatment with AFINITOR as it may make the amount of AFINITOR in their blood increase to a harmful level.

Patients should not take AFINITOR tablets which are broken or crushed. Patients should not chew or crush the tablets.

Liver Problems & Other Medical Conditions: The amount of AFINITOR in the blood was increased in patients who had liver problems. Patients should tell their healthcare provider about all their medical conditions including if they have or have had liver problems, diabetes or high blood sugar, high cholesterol levels, infections, hepatitis B, or other medical conditions.

Vaccinations: Patients should tell their healthcare provider if they are scheduled to receive any vaccinations. Patients should not receive a live vaccine or be around people who have recently received a live vaccine during treatment with AFINITOR.

Use in pregnancy: It is not known if AFINITOR will harm an unborn baby. Women should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment.

Common side effects: Common side effects of AFINITOR include infections of the respiratory tract, sinuses and ears; mouth ulcers; diarrhea and constipation; vomiting; stomach pain; fever; seizure; headache; dizziness; skin problems (such as rash, acne, dry skin, or scratching of the skin); cough; stuffy or runny nose; change in personality; low white blood cells (a type of blood cell that fights infection); high levels of fats in the blood (raised triglycerides).

Patients should tell their healthcare provider if they have any side effect that bothers them or does not go away.

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 click here for full Prescribing Information for AFINITOR.

Rapamune® and Torisel® are registered trademarks of Pfizer Inc.