Temsirolimus

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

Temsirolimus is used for:

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

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

Do NOT use temsirolimus if:

  • you are allergic to any ingredient in temsirolimus, unless your doctor tells you otherwise
  • if you have high blood bilirubin levels
  • you are taking St. John's wort

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

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Before using temsirolimus:

Some medical conditions may interact with temsirolimus. 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 or triglyceride levels, liver problems, bone marrow problems, certain blood problems (eg, low white blood cell or platelet levels), or a weakened immune system
  • if you have a certain type of tumor (eg, brain tumor), other cancers, an infection, or a wound, or if you have recently had or will be having surgery

Some MEDICINES MAY INTERACT with temsirolimus. 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, voriconazole), hepatitis C virus (HCV) protease inhibitors (eg, boceprevir), HIV protease inhibitors (eg, ritonavir), interferon alpha, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluvoxamine), sunitinib, or telithromycin because they may increase the risk of temsirolimus's side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, dexamethasone, hydantoins (eg, phenytoin), rifamycins (eg, rifabutin, rifampin), or St. John's wort because they may decrease temsirolimus's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if temsirolimus 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 temsirolimus:

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

  • Temsirolimus 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 temsirolimus.
  • You will receive an antihistamine (eg, diphenhydramine) about 30 minutes before temsirolimus to help decrease the risk of an allergic reaction. Tell your doctor before you receive temsirolimus if you miss your dose of the antihistamine.
  • If you miss a dose of temsirolimus, contact your doctor right away.

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

Important safety information:

  • Severe and sometimes fatal infusion reactions have occurred with the use of temsirolimus. These reactions may occur during the first infusion or during subsequent infusions. Your health care provider will monitor you closely for an infusion reaction while you receive temsirolimus. Tell your doctor immediately if you experience chest pain; fainting; flushing; hives; itching; rash; severe dizziness or light-headedness; shortness of breath or trouble breathing; swelling of the mouth, face, lips, or tongue; tightness in the chest; unusual hoarseness; or wheezing.
  • Tell your doctor or dentist that you take temsirolimus 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 temsirolimus.
  • Temsirolimus 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 temsirolimus. Avoid close contact with anyone who has recently received a live vaccine. Talk with your doctor before you receive any vaccine.
  • Temsirolimus 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 temsirolimus. 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 temsirolimus and for 3 months after you stop using it. If you have questions about effective birth control, talk with your doctor.
  • Men who use temsirolimus should always use effective birth control when having sex with a woman who may become pregnant. Do this for as long as you use temsirolimus 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, lung CT scan or chest x-rays, blood cholesterol and triglyceride levels, blood glucose levels, and complete blood cell counts, may be performed while you use temsirolimus. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use temsirolimus with caution in the ELDERLY; they may be more sensitive to its effects, especially diarrhea, pneumonia, or swelling (edema).
  • Temsirolimus should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Temsirolimus may cause harm to the fetus. Do not become pregnant while you are using it and for 3 months after you stop temsirolimus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using temsirolimus while you are pregnant. It is not known if temsirolimus is found in breast milk. Do not breast-feed while taking temsirolimus.

Possible side effects of temsirolimus:

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 or sores; nausea; nosebleed; runny nose; stomach pain or upset; taste changes; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

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 or leg pain, swelling, redness, 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; pain, redness, swelling, or warmth at the injection site; red, swollen, blistered, or peeling skin; severe or persistent dizziness or 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bloody or black, tarry stools; calf or leg pain, swelling, redness, or tenderness; chest pain; coughing up blood; mental or mood changes; seizures; severe stomach pain; trouble breathing.

Proper storage of temsirolimus:

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

General information:

  • If you have any questions about temsirolimus, please talk with your doctor, pharmacist, or other health care provider.
  • Temsirolimus 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take temsirolimus or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about temsirolimus. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to temsirolimus. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using temsirolimus.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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