Torisel

Generic Name: temsirolimus (TEM sir OH li mus)

What is Torisel?

Torisel is a cancer medication. It slows 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 other purposes not listed in this medication guide.

Important information about Torisel

FDA pregnancy category D. Torisel can cause harm to an unborn baby. Do not receive this medication without telling your doctor if you are pregnant. 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 Torisel.

Torisel can lower the blood cells that help your body fight infections. Avoid contact with people who have colds, the flu, or other contagious illnesses. Do not receive any vaccines. Contact your doctor immediately if you develop signs of infection.

Before receiving Torisel

You should not use Torisel if you are allergic to temsirolimus.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

high cholesterol or triglycerides;

diabetes;

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

if you are allergic to sirolimus (Rapamune).

FDA pregnancy category D. Torisel can cause harm to an unborn baby. Do not receive Torisel without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using Torisel and for at least 3 months after your treatment ends.

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.

It is not known whether temsirolimus passes into breast milk or if it could harm a nursing baby. Do not receive Torisel without telling your doctor if you are breast-feeding a baby.

How is Torisel given?

Torisel is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 1 hour to complete.

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

You may receive other medications before your Torisel infusion. These medications will help prevent certain side effects.

Torisel can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using Torisel. Temsirolimus can make it harder for wounds to heal, and you may need to stop using the medicine for a short time.

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 if you think you have received too much of this medicine.

Overdose symptoms may include black or bloody stools, severe stomach pain, confusion, unusual thoughts or behavior, sudden numbness or weakness, sudden headache, problems with vision or speech, pain or swelling in one or both legs, or seizure (convulsions).

What should I avoid while receiving Torisel?

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not receive a “live” vaccine while you are being treated with 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.

Grapefruit and grapefruit juice may interact with Torisel and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Torisel side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Torisel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

chest pain;

cough, feeling short of breath;

warmth, redness, or tingly feeling under your skin;

increased thirst, hunger, or urination;

black, bloody, or tarry stools;

fever, severe stomach pain;

urinating less than usual or not at all;

drowsiness, confusion, mood changes, loss of appetite, nausea and vomiting;

swelling, weight gain; or

pale skin, easy bruising or bleeding, weakness.

Less serious Torisel side effects include:

minor skin rash; or

white patches or sores inside your mouth or on your lips.

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.

What other drugs will affect Torisel?

Before receiving Torisel, tell your doctor if you are using any of the following drugs:

dexamethasone (Decadron, Hexadrol);

rifabutin (Mycobutin);

rifampin (Rifadin, Rimactane, Rifater);

St. John’s wort;

sunitinib (Sutent);

a blood thinner such as warfarin (Coumadin);

insulin or diabetes medications you take by mouth;

an antibiotic such as clarithromycin (Biaxin), telithromycin (Ketek) and others;

an antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

HIV/AIDS medicine such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), or saquinavir (Invirase, Fortovase); or

seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs not listed that can affect Torisel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.