torisel

Torisel(temsirolimus) is a cancer medication 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.

Important information

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.

If a man fathers a child while using Torisel, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using this medicine.

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.

Torisel 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 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.

You should not use Torisel if you are allergic to temsirolimus, or if you have:

• severe liver disease.

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

• liver disease;

• kidney disease;

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

• diabetes;

• a history of head injury, stroke, or brain tumor; or

• if you are allergic to sirolimus (Rapamune).

FDA pregnancy category D. Do not use Torisel if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 3 months after your treatment ends.

See also: Pregnancy and breastfeeding warnings (in more detail)

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using Torisel.

Use birth control to prevent pregnancy while you are receiving Torisel, whether you are a man or a woman. Torisel use by either parent may cause birth defects.

It is not known whether temsirolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.

How is Torisel given?

Torisel is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. The infusion must be given slowly, and can take up to 60 minutes to complete.

Torisel is usually given once each week unless your cancer progresses or you have serious side effects from this medicine.

You may be given medication to prevent certain side effects while you are receiving Torisel.

Torisel can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your kidney function may also need to be tested. Your cancer treatments may be delayed based on the results of these tests.

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

Torisel dosing information

Usual Adult Dose for Renal Cell Carcinoma:

Initial dose: 25 mg infused over a 30 to 60 minute period once a week

Treatment may continue until disease progression or unacceptable toxicity.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while receiving Torisel?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

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

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). 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. Patients and caregivers should wear rubber gloves while cleaning up 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.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Do not receive a "live" vaccine while using Torisel, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Torisel side effects

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

Get emergency medical help if you have any of these signs of an allergic reaction to Torisel: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• signs of infection - fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

• low potassium - confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, 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:

• mild itching or rash;

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

• swelling, rapid weight gain;

• mouth sores or ulcers, decreased sense of taste;

• headache, joint pain;

• cold symptoms such as stuffy nose, sneezing, cough;

• fever, weakness, flu symptoms; or

• abnormal liver or kidney function 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.

See also: Side effects (in more detail)

What other drugs will affect Torisel?

Many drugs can interact with temsirolimus. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Torisel, especially:

• St. John"s Wort;

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

• an antibiotic - clarithromycin, erythromycin, rifampicin, rifabutin;

• antifungal medicine - itraconazole, ketoconazole, voriconazole;

• an antidepressant - citalopram, escitalopram, fluoxetine (Prozac), nefazodone, paroxetine, sertraline;

• the hepatitis C medications boceprevir or telaprevir;

• HIV or AIDS medications - atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, tenofovir, and others; or

• seizure medicine - carbamazepine, phenobarbital, phenytoin.

This list is not complete and many other drugs can interact with temsirolimus. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.