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.
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.
- Even after you receive 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 HCP if you are allergic to TORISEL or antihistamine or if you cannot take antihistamines for any other reason.
- During treatment, tell your HCP 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 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.
- Tell your HCP if you are thirstier than normal, urinating more than normal, feeling
hungrier, gaining or losing weight, or feeling tired or irritated.
Increased cholesterol, triglycerides, or both
You are likely to
have an increase in cholesterol, triglycerides, or both when getting TORISEL.
- This may require treatment with, or an increase in the dose of, a medicine that
lowers cholesterol, triglycerides, or both.
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.
In some people, treatment with TORISEL has been associated
with a lung disease that can lead to inflammation and scarring, including rare fatalities.
- Tell your HCP right away if you have any trouble with breathing, coughing, or wheezing. Also tell your HCP if you feel pain in your chest or develop a fever.
- Your doctor may perform tests before and during TORISEL therapy to make sure you don’t have or develop serious lung issues.
Some people who received TORISEL developed tears
in the walls of their intestines.
- Fatal cases have been reported (one fatal case was reported in the main TORISEL trial).
- Tell your HCP right away if you have any new or worsening stomach pain, blood in your stool, chills, nausea, or vomiting.
Abnormal wound healing
During treatment with TORISEL, wounds may
not heal properly.
- Tell your HCP if you are recovering from surgery or have an unhealed wound.
- Tell your HCP if you plan to have surgery during treatment with TORISEL.
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.
- You should avoid the use of live vaccines and close contact with those who have recently received live vaccines.
- Ask your HCP if you can receive a flu shot.
TORISEL can harm an unborn baby.
- Both men and women should use a reliable form of birth control during and for 3 months after the last dose of TORISEL.
- Tell your HCP before beginning treatment if you or your partner are pregnant or thinking of becoming pregnant.
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:
- Edema (swelling)
- Before you start treatment with TORISEL, it’s important to tell your health care
provider (HCP) about ALL MEDICINES you are taking.
- Prescription medicines, especially, but not limited to, antibiotics, antiseizure
medicines, antidepressants, antifungals, antivirals, blood thinners, steroids such
as dexamethasone, vaccines, and blood pressure medicines
- Nonprescription (over-the-counter) medicines
- Herbal supplements, including, but not limited to, St. John’s Wort
- Other cancer treatments
- Tell your HCP if you are pregnant, if you plan to become pregnant, or if you have a partner
who may become pregnant.
- Tell your HCP if you are allergic to TORISEL or antihistamines.
- Tell your HCP if you have any swelling around your face or difficulty breathing
during or after treatment.
- Avoid eating grapefruit or drinking grapefruit juice. It may change the amount of
TORISEL in your body.
Before treatment with TORISEL begins, you may want to ask your HCP:
- If it’s okay to eat before getting TORISEL
- If you can get TORISEL after taking other medicines earlier in the day
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