Torisel

Torisel is used for:

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Treating advanced kidney cancer. It may also be used for other conditions as determined by your doctor.

Torisel is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use Torisel if:

• you are allergic to any ingredient in Torisel , unless your doctor tells you otherwise
• you are taking St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using Torisel :

Some medical conditions may interact with Torisel . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are allergic to sirolimus, polysorbate 80, antihistamines (eg, diphenhydramine), rubber, or latex
• if you have diabetes, high cholesterol, liver problems, bone marrow problems, certain blood problems (eg, low white blood cell or platelet levels), or a weakened immune system
• if you have other cancers (eg, brain tumor), an infection, or a wound, or if you have recently had surgery

Some MEDICINES MAY INTERACT with Torisel . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of severe bleeding may be increased
• Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril) because a severe reaction that may include swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; or unusual hoarseness may occur
• Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, ritonavir), interferon alpha, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, serotonin specific reuptake inhibitors (SSRIs) (eg, fluvoxamine), sunitinib, telithromycin, or voriconazole because they may increase the risk of Torisel 's side effects
• Barbiturates (eg, phenobarbital), carbamazepine, dexamethasone, hydantoins (eg, phenytoin), rifabutin, rifampicin, rifampin, or St. John's wort because they may decrease Torisel 's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Torisel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Torisel :

Use Torisel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Torisel is usually given as an injection at your doctor's office, hospital, or clinic.
• Do not eat grapefruit or drink grapefruit juice while you use Torisel .
• You will receive an antihistamine (eg, diphenhydramine) about 30 minutes before Torisel to help decrease the risk of an allergic reaction. Tell your doctor before you receive Torisel if you miss your dose of the antihistamine.
• If you miss a dose of Torisel , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Torisel .

Important safety information:

• Tell your doctor or dentist that you take Torisel before you receive any medical or dental care, emergency care, or surgery.
• Contact your doctor if you have a wound that does not heal properly while you are using Torisel .
• Torisel may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Torisel . Avoid close contact with anyone who has recently received a live vaccine. Talk with your doctor before you receive any vaccine.
• Torisel may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Interstitial lung disease is a severe and possibly fatal reaction that may occur with the use of Torisel . Tell your doctor right away if you develop fever, shortness of breath, cough, or any other new or worsening breathing problems.
• If you may become pregnant, you must use an effective form of birth control while you use Torisel and for 3 months after you stop using it. If you have questions about effective birth control, talk with your doctor.
• Men who use Torisel should always use effective birth control when having sex with a woman who may become pregnant. Do this for as long as you use Torisel and for 3 months after you stop using it. If you have questions about effective birth control, talk with your doctor.
• Lab tests, including kidney function, blood cholesterol levels, blood glucose levels, and complete blood cell counts, may be performed while you use Torisel . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Torisel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Torisel may cause harm to the fetus. Do not become pregnant while you are using it and for 3 months after you stop Torisel . If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Torisel while you are pregnant. It is not known if Torisel is found in breast milk. Do not breast-feed while taking Torisel .

Possible side effects of Torisel :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; back pain; constipation; diarrhea; dry skin; fingernail or toenail changes; headache; joint or muscle pain; loss of appetite; mouth pain; nausea; nosebleed; runny nose; stomach pain or upset; taste changes; trouble sleeping; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; calf pain or tenderness; chest pain; cough; coughing blood; decreased, difficult, or painful urination; depression; eye pain, redness, or swelling; fast or irregular heartbeat; fever, chills, or sore throat; new or worsening shortness of breath or other breathing problems; severe or persistent headache; severe or persistent stomach pain or diarrhea; severe tiredness or weakness; swelling of the hands, feet, or ankles; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; unusual drowsiness); unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bloody or black, tarry stools; calf pain or tenderness; chest pain; coughing of blood; mental changes; seizures; severe abdominal pain; trouble breathing.

Torisel is usually handled and stored by a health care provider. If you are using Torisel at home, store Torisel as directed by your pharmacist or health care provider. Do not store in the bathroom. Keep Torisel out of the reach of children and away from pets.

General information:

• If you have any questions about Torisel , please talk with your doctor, pharmacist, or other health care provider.
• Torisel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Torisel . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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