TORISEL Side Effects
Like all medicines, TORISEL can cause side effects, some of which can be serious. Be sure to tell your health care professional about any changes in the way you look or feel during treatment.
Take advantage of your weekly visits to the doctor’s office
If you experience any side effects between visits — don’t wait.
Call and tell your doctor or nurse right away!
Common TORISEL side effects
The most common side effects (occurring in 30% or more of patients) observed with TORISEL in clinical studies were1[1F, 1G, 1I -- PI, p. 12, 13, 14]:
- Rash
- Weakness/fatigue (asthenia)
- Mouth sores (mucositis)
- Nausea
- Swelling/fluid retention (edema)
- Loss of appetite (anorexia)
Some common abnormalities found in blood tests1[1H -- PI, p. 15]
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Increased blood sugar levels (hyperglycemia)
- 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 normal or urinate more than usual
-
Increased cholesterol and/or triglycerides
- This may require treatment with, or an increase in the dose of, a medicine that lowers cholesterol and/or triglycerides
-
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
If you experience any of these side effects, discuss with your health care team the best ways to manage them.
Additional information on TORISEL side effects
These side effects may be serious.
Allergic reactions1[1K -- PI, p. 8-9]
- Some patients in clinical studies had allergic reactions to TORISEL.
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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 if you get an antihistamine before treatment, you may still have an allergic reaction.
- Let your doctor know if you are allergic to antihistamines or cannot receive them for other medical reasons.
- Tell your doctor or nurse if you have any swelling around your face or difficulty breathing during or after treatment.
Infections1[1L -- PI, p. 9]
- Treatment with TORISEL may affect your immune system, and you may be at greater risk of getting an infection while receiving TORISEL.
- Your doctor and nurse should keep a close watch for any signs of infection while you are on TORISEL so that if you do get an infection, it can be treated right away.
Bowel perforation1[1M -- PI, p. 10]
- TORISEL may cause bowel perforation (a tear in the wall of the intestines). Rare 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.
Chronic inflammation of the lungs1[1N -- PI, p. 9]
- Some 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, get a cough, or develop a fever.
Kidney failure1[1O -- PI, p. 10]
- Treatment with TORISEL may be associated with a risk of kidney failure, sometimes fatal.
- Tell your doctor or nurse if you have any kidney conditions other than cancer.
Abnormal wound healing1[1P -- PI, p. 10]
- 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.
Bleeding in the brain1[1Q -- PI, p. 10]
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TORISEL may increase the risk of bleeding in the brain, which has, in rare 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
- Discuss with your doctor whether you may be at risk for this serious side effect.
Important Safety Information
- Before you begin treatment with TORISEL, your doctor may give you an antihistamine. It is possible to have a serious 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 difficulty breathing during or after treatment.
-
TORISEL can cause serious side effects. The most common side effects are
- Rash
- Weakness/fatigue
- Mouth sores
- Nausea
- Swelling/fluid retention
- Loss of appetite
- 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.
- 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, 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.
Please see Important Safety Information continued on the next page.
- Treatment with TORISEL may affect your immune system. You may be at greater risk of getting an infection while receiving TORISEL.
Please see Important Safety Information continued on the next page.
Please see accompanying full Prescribing Information.
- 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, get a cough, or develop a fever.
- TORISEL may cause bowel perforation. Rare 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 rare 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.
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:
- TORISEL® Kit (temsirolimus) Prescribing Information, Wyeth Pharmaceuticals Inc.