How TORISEL Is Given

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  • TORISEL is given intravenously.1[1V – PI, p. 6]
    • An intravenous (IV) infusion is a common way of giving certain medicines. The medicine is contained in a bag or bottle hanging upside down. A thin tube connects the bag or bottle to your vein so that the medicine can enter your bloodstream directly.
  • Thirty minutes before you receive TORISEL, your doctor may give you an intravenous antihistamine,1[1V – PI, p. 6] like Benadryl®. This is a type of medicine that can help reduce the chances of an allergic reaction.
    • Even after you recieve an antihistamine, it is possible to have an allergic reaction or even a severe reaction called anaphylaxis, which may result in death. Common symptoms of anaphylaxis include abdominal cramps/pain, chest discomfort, diarrhea, and difficulty breathing.
    • Tell your doctor or nurse if you are allergic to this type of medicine.
    • During treatment, tell your doctor or nurse if you have any swelling around your face, difficulty breathing, chest pain, flushing, hives, itching, wheezing, crampy abdominal pain, diarrhea, vomiting, irregular heartbeat, light-headedness, anxiety, or weakness in your muscles.
  • You will receive treatment:
    • In a hospital, clinic, doctor's practice, or infusion center
    • Once a week1[1V – PI, p. 6]
    • Over a 30- to 60-minute period1[1V – PI, p. 6]
      • If your health care professional gives you an antihistamine, the total treatment time could take 60 to 90 minutes.
  • TORISEL is given to you by your doctor or nurse in a special room called an infusion suite. Infusion suites have comfortable chairs for you to sit in as you receive treatment. You may find that infusion sessions provide an opportunity to:
    • Read
    • Chat with friends or family members
    • Take a nap
  • Your blood may be tested before you begin treatment and at other times over the course of therapy
    • Your doctor or nurse may have you fast (not eat or drink) before blood tests

Connecting with your health care team during infusions

  • Your TORISEL infusion sessions will bring you into contact with members of your health care team on a weekly basis. This may provide you with regular opportunities to:
    • Learn more about RCC and management options
    • Ask your health care team questions about your care
    • Get updates about advanced RCC developments

Tip: Bring a notebook to your infusion appointment to write down questions you may have and record information discussed

Benadryl is a registered trademark of Johnson & Johnson Corporation.

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.
  • TORISEL can cause serious side effects. 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, your doctor may give you an antihistamine. It is possible to have a serious (including a life-threatening or fatal) 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 trouble breathing during or after treatment with TORISEL.
  • 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.
  • 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, as they may change the amount of TORISEL in your body.
  • Treatment with TORISEL may affect your immune system. You may be at greater risk of getting an infection while receiving TORISEL.
  • 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, or develop a cough or fever.
  • TORISEL may cause bowel perforation. 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 some 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.
  • Elderly patients may be more likely to experience certain side effects including diarrhea, edema and pneumonia.
  • The most common side effects are
    • Rash
    • Weakness/fatigue
    • Mouth sores
    • Nausea
    • Swelling/fluid retention
    • Loss of appetite


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, June 2011.

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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]While TORISEL has been shown to extend survival, it is not a cure for advanced RCC.1

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.