Torisel is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Torisel is used to treat cancer of the kidneys, also called renal cell carcinoma.

Torisel may also be used for purposes not listed in this medication guide.

You should not use Torisel if you are allergic to temsirolimus or if you have severe liver disease. Do not use Torisel if you are pregnant. It could harm the unborn baby. Use an effective form of birth control while you are using this medication and for at least 3 months after your treatment ends.

Before you receive Torisel, tell your doctor if you have liver disease, high cholesterol, diabetes, an allergy to sirolimus (Rapamune), or a history of head injury, stroke, or brain tumor.

Temsirolimus can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Do not receive a live vaccine. Tell your doctor at once if you develop signs of infection.

There are many other drugs that can interact with temsirolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

There are many other drugs that can interact with Torisel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Before taking this medicine

You should not use Torisel if you have severe liver disease.

To make sure Torisel is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• high cholesterol or triglycerides (a type of fat in the blood);

• diabetes;

• a head injury or brain tumor; or

• an allergy to temsirolimus or sirolimus (Rapamune).

Both men and women using this medicine should use effective birth control to prevent pregnancy. Temsirolimus can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 3 months after your last dose of Torisel. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Torisel.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because temsirolimus can harm an unborn baby.

You should not breastfeed while using this medicine and for at least 3 weeks after your last dose.

Torisel is given as an infusion into a vein. A healthcare provider will give you this injection.

Torisel is usually given once each week unless your cancer progresses or you have serious side effects from this medicine. This medicine must be given slowly, and the infusion can take up to 60 minutes to complete.

You may be given other medication to prevent an allergic reaction to Torisel.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

If you need surgery, tell the surgeon ahead of time that you are using Torisel.

Usual Adult Dose for Renal Cell Carcinoma:

25 mg IV infusion over a 30 to 60 minute period once a week
Duration of therapy: Treat until disease progression or unacceptable toxicity

Comments: IV diphenhydramine 25 to 50 mg (or similar antihistamine) should be given approximately 30 minutes before the start of each dose

Use: Advanced renal cell carcinoma

You should not use Torisel if you have severe liver disease.

To make sure Torisel is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• high cholesterol or triglycerides (a type of fat in the blood);

• diabetes;

• a head injury or brain tumor; or

• an allergy to temsirolimus or sirolimus (Rapamune).

Both men and women using this medicine should use effective birth control to prevent pregnancy. Temsirolimus can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 3 months after your last dose of Torisel. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Torisel.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because temsirolimus can harm an unborn baby.

You should not breastfeed while using this medicine and for at least 3 weeks after your last dose.

Call your doctor if you miss an appointment for your Torisel injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include breathing problems, confusion, seizure, or bloody stools.

Grapefruit may interact with temsirolimus and lead to unwanted side effects. Avoid the use of grapefruit products.

Do not receive a "live" vaccine while using Torisel. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Temsirolimus can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Torisel (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, warm, tingly, light-headed, or short of breath.

Call your doctor at once if you have:

• cough, chest pain, wheezing, trouble breathing;

• stomach pain, bloody or tarry stools;

• pain or burning when you urinate, blood in your urine;

• a surgical incision that will not heal;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• kidney problems - little or no urination, puffy eyes, swelling in your feet or ankles, weight gain, urine that looks foamy; or

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Side effects such as diarrhea, swelling, and breathing problems may be more likely in older adults.

Common Torisel side effects may include:

• low blood cell counts;

• feeling weak or tired;

• mouth sores or ulcers;

• nausea, vomiting, stomach pain, loss of appetite;

• swelling;

• headache, joint pain;

• rash; or

• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with temsirolimus, especially:

• sunitinib;

• St. John's Wort;

• an antibiotic or antifungal medicine;

• an antidepressant;

• antiviral medicine to treat hepatitis C or HIV/AIDS;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medicine, especially an ACE inhibitor or calcium channel blocker (such as amlodipine, benazepril, diltiazem, ramipril, verapamil, and many others);

• insulin or oral diabetes medicine; or

• seizure medicine.

This list is not complete and many other drugs may affect Torisel. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.