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. 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, and blood sugar levels.

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 fungal infections, bacterial infections, tuberculosis, seizures, 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 and 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 mouth ulcers; feeling weak or tired; cough and shortness of breath; diarrhea; skin problems (such as 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; and pain in arms and legs.

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 see full Prescribing Information for AFINITOR.

Sutent^®, Rapamune^® and Torisel^® are registered trademarks of Pfizer Inc.
Nexavar^® is a registered trademark of Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc.