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AFINITOR®
(a-fin-it-or)
(everolimus) tablets

Read this Patient Information leaflet that comes with AFINITOR before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about 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 healthcare provider right away if you have any of these symptoms:

• New or worsening cough
• Shortness of breath
• Chest pain
• Difficulty breathing or wheezing

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 healthcare provider right away if you 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
• Pain in your upper right side

3. You may develop kidney failure. In some people this may be severe and can even lead to death. Your healthcare provider should do tests to check your kidney function before and during your treatment with AFINITOR.

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 healthcare provider's instructions.

What is AFINITOR?

AFINITOR is a prescription medicine used to treat:

• people with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET), that has progressed and can not be treated with surgery. It is not known if AFINITOR is safe and effective in people with carcinoid tumors.
• people with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked.
• people with the following types of tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC):
• a kidney tumor called angiomyolipoma, when their kidney tumor does not require surgery right away.
• a brain tumor called subependymal giant cell astrocytoma (SEGA).

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

Who should not take AFINITOR?

Do not take AFINITOR if you are allergic to AFINITOR or to any of its ingredients. See the end of this leaflet for a complete list of ingredients in AFINITOR. Talk to your healthcare provider before taking this medicine if you are allergic to:

• sirolimus (Rapamune®)
• temsirolimus (Torisel®)

Ask your healthcare provider if you do not know.

What should I tell my healthcare provider before taking AFINITOR?

Before taking AFINITOR, tell your healthcare provider about all of 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, ask your healthcare provider.
• Have other medical conditions.
• Are pregnant, or could become pregnant. It is not known if AFINITOR will harm your unborn baby. You should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment.
• Are breast-feeding or plan to breast-feed. It is not known if AFINITOR passes into your breast milk. 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 non-prescription medicines, vitamins, and herbal supplements.

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.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your healthcare provider if you take:

• St. John's Wort (Hypericum perforatum)
• Medicine for:
  • Fungal infections
  • Bacterial infections
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • Heart conditions or high blood pressure
• Medicines that suppress your immune system

Ask your healthcare 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 healthcare provider might need to prescribe a different medicine or your dose of AFINITOR may need to be changed. You should also tell your healthcare provider before you start taking any new medicine.

How should I take AFINITOR?

• Your healthcare provider will prescribe the dose of AFINITOR that is right for you.
• Take AFINITOR exactly as your healthcare provider tells you. Your healthcare provider may change your dose of AFINITOR if needed.
• Swallow AFINITOR tablets whole with a glass of water.
• If you cannot swallow AFINITOR tablets whole, you can stir them into a glass of water:
  • Put the prescribed number of tablets into a glass that contains about 2 Tablespoons (30 ml_) of water
  • Gently stir the contents until the tablets break apart and then drink the mixture right away
  • Add about 2 Tablespoons (30 ml_) of water to the glass and drink all of the water. This will help to make sure that you get the full dose of AFINITOR.
• Take AFINITOR one time every day, at about the same time every day.
• Take AFINITOR the same way each time, either with food or without food.
• You may use scissors to open the blister to avoid spillage.
• If you take too much AFINITOR contact your healthcare provider or go to the nearest hospital emergency department right away. Take the pack of AFINITOR with you.
• If you miss a dose of AFINITOR, you may still take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your AFINITOR, skip the dose for that day. The next day, take AFINITOR at your usual time. Do not take 2 doses to make up for the one that you missed. If you are not sure about what to do, call your healthcare provider.
• You should have regular blood tests before you start AFINITOR and as needed during your treatment. These will include tests to check your blood cell count, kidney and liver function, cholesterol, and blood sugar levels.
• If you take AFINITOR to treat SEGA, you will need to have regular blood tests to measure how much AFINITOR is in your blood. This will help your healthcare provider decide how much AFINITOR you need to take.

What should I avoid while taking AFINITOR?

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.

What are the possible side effects of AFINITOR?

AFINITOR can cause serious side effects.

• See "What is the most important information I should know about AFINITOR?"

Common side effects of AFINITOR in people with advanced pancreatic neuroendocrine tumors and patients with advanced kidney cancer 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 mouth gel that does not contain alcohol or peroxide.
• Feeling weak or tired
• Cough, shortness of breath
• Diarrhea
• Rash, dry skin, and itching
• Nausea and vomiting
• Fever
• Loss of appetite
• Swelling of arms, hands, feet, ankles, face or other parts of the body
• Abnormal taste
• Inflammation of lining of the digestive system
• Headache
• Nose bleeds
• Pain in arms and legs

Common side effects of AFINITOR in patients who have angiomyolipoma with TSC 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 mouth gel that does not contain alcohol or peroxide.
• Acne or eczema
• Nausea and vomiting
• Headache
• Cough
• Diarrhea
• Joint pain
• Swelling of your hands, arms, legs, and feet
• Stomach-area (abdomen) pain
• Respiratory tract infection
• Increased blood cholesterol level and certain other blood tests
• Decreased blood phosphate level
• Low red blood cells and white blood cells
• Increased blood sugar levels
• Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your healthcare provider if this happens.

Common side effects of AFINITOR in patients with SEGA include:

• Infections of the respiratory tract, sinuses and ears
• 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 mouth gel that does not contain alcohol or peroxide.
• 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; your healthcare provider will periodically check you for this problem)
• High levels of fats in the blood (raised triglycerides)

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 may report side effects to FDA at 1-800-FDA-1088.

How do I store AFINITOR?

• Store AFINITOR at room temperature, between 68°F to 77°F (20°C to 25°C)
• Keep AFINITOR in the package it comes in.
• Open the blister package just before taking AFINITOR.
• Keep the blister package and tablets dry prior to taking.
• Keep AFINITOR out of light.
• Throw away AFINITOR that is out of date or no longer needed.

Keep AFINITOR and all medicines out of the reach of children.

General information about AFINITOR

Medicines are sometimes prescribed for conditions that are not mentioned in a patient information leaflet. Do not use AFINITOR for a condition for which it was not prescribed. Do not give AFINITOR to other people, even if they have the same problem you have. It may harm them.

This leaflet summarizes the most important information about AFINITOR. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information written for healthcare professionals.

For more information call 1-888-423-4648 or go to www.AFINITOR.com.

What are the ingredients in AFINITOR?

Active ingredient: everolimus.

Inactive ingredients: butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone, and lactose anhydrous.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 5/7/2012
This monograph has been modified to include the generic and brand name in many instances.