Read this section and Side Effects, to learn about important information for patients taking TORISEL.
Important safety considerations
Before starting TORISEL, you should be aware of potentially serious side effects and other safety considerations. Some of these side effects may be easy to notice. Others may be impossible to recognize without special tests that your HCP may require. Patients should always ask their doctors for medical advice about adverse events.
Some patients in clinical studies had allergic reactions to TORISEL. For this reason, it is recommended that patients receive a medicine (antihistamine) before treatment with TORISEL to lower the chances of an allergic reaction.
You should not receive TORISEL if blood 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.
Increased blood sugar levels
You are likely to have raised blood sugar levels when getting TORISEL. This may require treatment with, or an increase in the dose of, a medicine that lowers blood sugar levels.
Increased cholesterol, triglycerides, or both
You are likely to have an increase in cholesterol, triglycerides, or both when getting TORISEL.
Problems with the immune system
Your immune system may not work normally while you are taking TORISEL. This means you may be at greater risk of getting an infection while receiving TORISEL. Your doctor will monitor you for signs of infection.
Some people may develop Pneumocystis jiroveci pneumonia (PJP). This is a type of fungal lung infection. And it can cause death. This fungal lung infection may be related to the use of TORISEL and corticosteroids or other medicines that suppress the immune system.
In some people, treatment with TORISEL has been associated with a lung disease that can lead to inflammation and scarring, including rare fatalities.
Some people who received TORISEL developed tears in the walls of their intestines.
Abnormal wound healing
During treatment with TORISEL, wounds may not heal properly.
Increased risk of bleeding in the brain
TORISEL may increase the risk of bleeding in the brain, which has, in some cases, been fatal. You may be at an increased risk if you have a central nervous system tumor (such as a brain tumor) or are taking medicine to keep your blood from clotting.
Treatment with TORISEL may be associated with a risk of kidney failure, sometimes fatal.
Some vaccines may be harmful or less effective when given during the course of treatment with TORISEL.
TORISEL can harm an unborn baby.
Concerns for people 65 or older
If you are 65 or older, you may be more likely to experience certain issues during TORISEL therapy, including:
Steps to take before and during TORISEL treatment
Before treatment with TORISEL begins, you may want to ask your HCP:
Your blood may be tested before you start TORISEL treatment and at other times over the course of therapy. Your HCP may tell you not to eat or drink before blood tests.
Read about TORISEL Side Effects.
TORISEL is indicated for the treatment of advanced renal cell carcinoma.
Patients should always ask their doctors for medical advice about adverse events.
You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.