How TORISEL Is Given

TORISEL is given intravenously.

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• TORISEL is given once a week as an IV infusion lasting 30-60 minutes.
  
• 30 minutes before you get TORISEL, your health care provider (HCP) is likely to give you an IV antihistamine. This is to decrease the risk of an allergic reaction.
  • It is possible to have an allergic reaction even after you receive an antihistamine.
  • It is even possible to have a severe reaction called anaphylaxis. This may result in death.
• Tell your doctor if you are allergic to TORISEL or antihistamines or if you cannot take antihistamines for any other reasons.
  
• During treatment, tell your doctor if you don't feel well or if you have any of the following:
  • swelling around your face
  • difficulty breathing
  • chest pain
  • flushing
  • hives
  • itching
  • wheezing
  • crampy abdominal pain
  • diarrhea
  • vomiting
  • irregular heartbeat
  • light headedness
  • anxiety
  • weakness in your muscles

Where TORISEL is given

TORISEL is given to you by your HCP in a special room called an infusion suite. Infusion suites can be found at:

• hospitals
• clinics
• your HCP's office
• infusion centers

Infusion suites have comfortable chairs for you to sit in as you get treatment. You may find that infusion sessions give you an opportunity to:

• read
• chat with friends or family members
• take a nap

Connecting with your health care team during infusions

Your TORISEL infusion sessions will bring you in contact with members of your health care team on a weekly basis. This may give you regular opportunities to:

• Learn more about RCC and management options
• Ask your health care team questions about your care

Preparing for TORISEL treatment

• Tell all your HCPs you are receiving TORISEL.
• Arrange for a friend or family member to drive you to and from your weekly appointment.
  • Treatment with TORISEL may make you feel weak or sick.
• Maintain good oral hygiene.
  • Basic oral care may help make mouth sores less severe. Mouth sores can be a side effect of TORISEL.
• Talk to your HCP about diet and exercise.
• Tell your HCP about any changes in the way you look or feel during treatment.
  • These may be signs of side effects or a change in your disease.

Learn more about TORISEL Side Effects

Get tips on Talking to Your Doctor About TORISEL

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intravenously: also called IV, a common way to give certain medicines. The medicine is contained in a bag or bottle. A thin tube connects the bag or bottle to a needle. The needle goes into a vein to supply the medicine directly to the bloodstream.

antihistamine: a medicine that can help lower the chance of an allergic reaction. Benadryl^® is an example of a common antihistamine.

anaphylaxis: a severe type of allergic reaction. Common symptoms include abdominal cramps/pain, chest discomfort, diarrhea, and difficulty breathing. It may result in death.

infusion centers: facilities that specialize in giving people IV medications

Indication

TORISEL is indicated for the treatment of advanced renal cell carcinoma.

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 from surgery or have an unhealed wound. 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

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