temsirolimus

Generic Name: temsirolimus (TEM sir OH li mus)
Brand Name: Torisel

What is temsirolimus?

Temsirolimus is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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

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

What is the most important information I should know about temsirolimus?

You should not use this medication if you are allergic to temsirolimus or if you have severe liver disease.

Do not use temsirolimus 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 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 temsirolimus.

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Before you receive temsirolimus, 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.

What should I discuss with my doctor before receiving temsirolimus?

You should not use this medication if you are allergic to temsirolimus or if you have severe liver disease.

To make sure you can safely receive temsirolimus, tell your doctor if you have any of these other conditions:

  • liver 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 temsirolimus if you are pregnant. It could harm the unborn baby. Use effective 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 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 temsirolimus.

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 temsirolimus.

How is temsirolimus given?

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

Temsirolimus 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 temsirolimus infusion. These medications will help prevent certain side effects.

Temsirolimus can lower 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. Your blood may need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

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

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while receiving temsirolimus?

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

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 temsirolimus, 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), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Grapefruit and grapefruit juice may interact with temsirolimus and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Temsirolimus side effects

Some people receiving a temsirolimus injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, warm, tingly, light-headed, short of breath, or have chest pain or trouble breathing during the injection.

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

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

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

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

  • drowsiness, confusion, mood changes, swelling, rapid weight gain;

  • loss of movement on one side of your body;

  • urinating less than usual or not at all;

  • pain or burning when you urinate;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

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

  • any wound that will not heal; or

  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects include mild skin rash

  • acne, dry skin, mild itching or rash;

  • nausea, vomiting, loss of appetite;

  • diarrhea, constipation;

  • hair loss;

  • muscle or joint pain, back pain;

  • headache, dizziness, problems with coordination;

  • pain, warmth, swelling, redness, itching, or irritation around the IV needle.

  • runny or stuffy nose, sinus pain;

  • depression, memory problems, sleep problems (insomnia), feeling weak or tired;

  • decreased sense of taste; or

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)

Temsirolimus 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 other drugs will affect temsirolimus?

Tell your doctor about all other medicines you use, especially:

  • conivaptan;

  • dexamethasone;

  • imatinib;

  • isoniazid (for treating tuberculosis);

  • St. John's wort;

  • sunitinib;

  • a blood thinner such as warfarin;

  • insulin or oral diabetes medications;

  • an antibiotic such as clarithromycin, erythromycin, rifabutin, rifampin, or telithromycin;

  • an antidepressant such as citalopram, escitalopram, fluoxetine, fluvoxamine, nefazodone, paroxetine, or sertraline;

  • antifungal medication such as itraconazole, ketoconazole, miconazole, or voriconazole;

  • heart or blood pressure medication such as nicardipine or quinidine;

  • HIV/AIDS medicine such as atazanavir, delavirdine, indinavir, nelfinavir, saquinavir or ritonavir; or

  • seizure medication such as carbamazepine, phenytoin, or phenobarbital.

This list is not complete and 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.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about temsirolimus.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision Date: 2013-07-09, 11:44:30 AM.

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