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.