Safety Considerations

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Read this section, in addition to TORISEL Side Effects, to learn about safety issues related to TORISEL.

You should not receive TORISEL if

  • Certain tests show that your liver function is moderately or severely impaired.1 [1K -- PI, p. 8-9]

TORISEL should be used with caution in

  • People who are allergic to temsirolimus, polysorbate 80, or any other component of TORISEL.1[1K -- PI, p. 8-9]
  • People who are allergic to antihistamines or people who cannot receive an antihistamine for other medical reasons.1[1K -- PI, p. 8-9]
  • Patients whose liver function is mildly impaired. TORISEL should be given at a reduced dose if it must be given to patients whose liver function is mildly impaired.1 [1K -- PI, p. 8-9]

Some medications and foods can interfere with TORISEL treatment

  • Before you begin treatment, tell your doctor or nurse about ALL MEDICINES you are taking, including:
    • Prescription medications, including but not limited to
      • Antibiotics
      • Antidepressants
      • Anticonvulsants
      • Antifungals
      • Antivirals
      • Blood pressure medications
      • Blood thinners
      • Dexamethasone
      • Vaccines
    • Nonprescription (over the counter) medications
    • Vitamins
    • Herbal supplements, including but not limited to St. John’s Wort
      • Do not take St. John’s Wort during the course of your treatment with TORISEL.1[1R -- PI, p. 6]
  • Avoid eating grapefruit or drinking grapefruit juice during the course of your treatment with TORISEL, including the time between treatments.1[1R -- PI, p. 6]

Other important safety information about treatment with TORISEL

  • Although TORISEL has not been studied in pregnant women, you should avoid becoming pregnant while receiving TORISEL, as it can harm the unborn baby.1[1F -- PI, p. 12]
    • Both men and women should use a reliable form of birth control during treatment with TORISEL and for 3 months after the last dose of TORISEL.
    • Tell your doctor before beginning treatment if you are pregnant or thinking of becoming pregnant.
  • Treatment with TORISEL may make you feel weak or sick.1[1F -- PI, p. 12]
    • For this reason, you may want to schedule someone to drive you to your weekly treatment appointments.
  • Some vaccines may be less effective when given during the course of treatment with TORISEL.
    • You should avoid the use of live vaccines and close contact with those who have recently received live vaccines.1 [1S -- PI, p. 11]
      • Ask your doctor or nurse if you are eligible to receive a flu shot.
      • Other live vaccines include measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines
  • Read about TORISEL Side Effects

Important Safety Information

  • You should not receive TORISEL if certain tests show that your liver function is moderately or severely impaired. TORISEL should be used with caution in patients whose liver function is mildly impaired and should be given at a reduced dose.
  • Before you begin treatment with TORISEL, your doctor may give you an antihistamine. It is possible to have a serious allergic reaction even after you receive an antihistamine. Tell your doctor or nurse if you are allergic to antihistamines or are unable to take antihistamines for any other medical reasons. Tell your doctor or nurse if you have any swelling around your face or difficulty breathing during or after treatment.
  • TORISEL can cause serious side effects. The most common side effects are
    • Rash
    • Weakness/fatigue
    • Mouth sores
    • Nausea
    • Swelling/fluid retention
    • Loss of appetite
  • Patients are likely to experience increased blood sugar levels. This may require treatment with or an increase in the dose of a medicine that lowers blood sugar levels. Tell your doctor or nurse if you are thirstier than usual or urinate more often than usual.
  • Patients are likely to experience an increase in cholesterol and/or triglycerides. This may require treatment with or an increase in the dose of a medicine that lowers cholesterol and/or triglycerides.
  • If you experience side effects that are too severe to tolerate, your health care professional may choose to delay your treatment, give you a lower dose of TORISEL, or discontinue treatment.
  • Before you begin treatment with TORISEL, tell your doctor or nurse about ALL MEDICINES you are taking, including
    • Prescription medications, including but not limited to antibiotics, anticonvulsants, antidepressants, antifungals, antivirals, blood pressure medications, blood thinners, dexamethasone, vaccines
    • Nonprescription (over the counter) medications
    • Vitamins
    • Herbal supplements, including but not limited to St. John’s Wort
  • Avoid eating grapefruit or drinking grapefruit juice during the course of your treatment with TORISEL, including the time between treatments.

Please see Important Safety Information continued on the next page.
  • Treatment with TORISEL may affect your immune system. You may be at greater risk of getting an infection while receiving TORISEL.



    Please see Important Safety Information continued on the next page.

    Please see accompanying full Prescribing Information.

  • Patients may get chronic inflammation of the lungs during treatment with TORISEL. Rare fatal cases have been reported. Tell your doctor or nurse right away if you have any trouble breathing, get a cough, or develop a fever.
  • TORISEL may cause bowel perforation. Rare fatal cases have been reported. Tell your doctor or nurse right away if you have any new or worsening stomach pain or blood in your stool.
  • Treatment with TORISEL may be associated with a risk of kidney failure, sometimes fatal.
  • During treatment with TORISEL, wounds may not heal properly. Tell your doctor or nurse if you are recovering or still have an unhealed wound from surgery. Tell your doctor or nurse if you plan to have surgery during treatment with TORISEL.
  • TORISEL may increase the risk of bleeding in the brain, which has, in rare cases, been fatal. You are at increased risk if
    • You have a central nervous system tumor, such as a brain tumor
    • You are taking medicine to keep your blood from clotting
  • Some vaccines may be less effective when given during the course of treatment with TORISEL. You should avoid the use of live vaccines and close contact with people who have recently received live vaccines. Ask your doctor or nurse if you are eligible to receive a flu shot.
  • Both men and women should use a reliable form of birth control during treatment and for 3 months after the last dose of TORISEL. TORISEL can harm an unborn baby. Tell your doctor or nurse before beginning treatment if you are pregnant or thinking of becoming pregnant.


Please see the full Prescribing Information for TORISEL.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


Reference:

  1. TORISEL® Kit (temsirolimus) Prescribing Information, Wyeth Pharmaceuticals Inc.

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TORISEL Clinical Trial

TORISEL has been proven to extend survival longer than interferon-alpha (another therapy) in patients with advanced RCC.1 [1A -- PI, p. 20]

Learn more about the effectiveness shown in the TORISEL Clinical Trial.

Learn more about TORISEL Side Effects.

Talk To Your Doctor

Doctor

Learn what information to share and what questions to ask when Talking To Your Doctor About TORISEL.