Torisel - Consumer Medicine Information
|Condition:||Metastatic Breast Cancer (Breast Cancer, Metastatic), Renal Cell Carcinoma|
|Class:||Antineoplastics, MTOR inhibitors|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||temsirolimus, dehydrated alcohol, d,l-alpha-tocopherol, propylene glycol, citric acid anhydrous; polysorbate 80, polyethylene glycol 400, dehydrated alcohol|
Temsirolimus Concentrate for Injection, 25mg/mL
About this Medication
What the Medication is Used For
TORISEL is used in the treatment of metastatic cancer of the kidney (when cancer cells have spread from kidney to other parts of the body).
What it Does
TORISEL is a selective inhibitor of mTOR (mammalian target of rapamycin) that blocks tumour cell growth and division.
When it Should not be Used
Do not take TORISEL if you:
- are allergic (hypersensitive) to temsirolimus, sirolimus or any of the other ingredients of TORISEL
- have moderate or severe liver problems
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
TORISEL: dehydrated alcohol, d,l-alpha-tocopherol, propylene glycol, citric acid anhydrous.
DILUENT for TORISEL: polysorbate 80, polyethylene glycol 400, dehydrated alcohol.
What Dosage Forms it Comes In
Concentrate for injection. Each mL contains 25 mg temsirolimus.
Warnings and Precautions
Serious Warnings and Precautions
TORISEL should be prescribed and managed by a doctor who is experienced in the use of anti-cancer drugs.
Possible serious side-effects with TORISEL include:
- Allergic (hypersensitivity/infusion) reactions
- Increased blood glucose levels
- Increased susceptibility to infections
- Chronic inflammation of the lungs (interstitial lung disease)
- Kidney failure
BEFORE you use TORISEL talk to your doctor or pharmacist if:
- You are allergic (hypersensitive) to antihistamines or cannot take antihistamines for other medical reasons.
- You are allergic (hypersensitive) to sirolimus (used to prevent the body from rejecting transplanted kidneys).
- You have diabetes or you experience any excessive thirst or increased frequency of urination. TORISEL may increase blood glucose levels. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycaemic agent therapy.
- You have problems with your heart.
- You have QT prolongation or a family history of QT prolongation.
- You have a personal history of fainting spells.
- You have a family history of sudden cardiac death at <50 years.
- You have electrolyte disturbances (e.g. low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g. vomiting, diarrhea, dehydration).
- You have an eating disorder or are following a strict diet.
- You have had a recent fever, sweats, chills or infection diagnosed. TORISEL may weaken your immune system, therefore, you may be at risk of getting an infection while you are taking TORISEL.
- You experience shortness of breath, cough, and fever or any new or worsening respiratory symptoms.
- You have kidney problems (in addition to kidney cancer)
- You have liver problems.
- You have known or suspected lesions of the gastrointestinal tract. TORISEL may cause bowel perforation. Rare fatal cases have been reported.
- You have high cholesterol. TORISEL may elevate triglycerides and/or cholesterol. This may require treatment with lipid lowering agents.
- You are going to have an operation, if you have had recent major surgery, or if you still have an unhealed wound following surgery, you should tell your doctor before receiving this medicine, as TORISEL may increase the risk of problems with wound healing.
- You are currently taking ACE inhibitors (used to treat high blood pressure and heart failure).
- You are planning to have a vaccination during treatment with TORISEL, the vaccination may be less effective. The use of live vaccines and close contact with people who have received live vaccines should be avoided during treatment with TORISEL.
- You have bleeding problems and/or receiving blood thinners. TORISEL may increase the risk of bleeding and/or bleeding in the brain.
- You are experiencing muscle pain or weakness.
- You are pregnant or are thinking about becoming pregnant. TORISEL may interfere with the growth and development of an unborn baby. You must use reliable methods of birth control during treatment and for 3 months after the last dose of TORISEL.
- You are a male and have a partner of childbearing potential. The affects of TORISEL on the fetus and sperm are unknown. You must use reliable methods of birth control during treatment and for 3 months after the last dose of TORISEL.
- You are breastfeeding during treatment with TORISEL. Women should not breast-feed during treatment, as this medicine may interfere with the growth and development of the baby. It is not known if TORISEL passes into breast milk.
Interactions With This Medication
Please tell your doctor if you are taking, or have recently taken, any other medicines including medicines obtained without a prescription.
Some medicines can interfere with the breakdown or metabolism of TORISEL. In particular, you should inform your doctor if you are taking any of the following:
- protease inhibitors (used in the treatment of HIV) such as indinavir, nelfinavir, ritonavir
- macrolide antibiotics (e.g., clarithromycin, erythromycin) or antifungal medicines (e.g., itraconazole, ketoconazole, voriconazole) used to treat infections
- nefazodone or selective serotonin re-uptake inhibitors used to treat depression
- anti-epileptic medicines including carbamazepine, phenytoin and barbiturates
- rifabutin used to treat infection in people with HIV
- rifampicin used to treat infections
- angiotensin converting enzyme (ACE)-inhibitors used to treat high blood pressure and heart failure such as enalapril, ramipril, lisinopril
- John’s Wort (Hypericum perforatum)
- drugs that prolong QT/QTc
- medications that can decrease body's natural defence response to infections, such as corticosteroids.
Non-human studies have shown that TORISEL interacts with digoxin (used to treat heart failure)
Proper Use of This Medication
TORISEL will always be prepared and given to you by a doctor or another healthcare professional.
The recommended dose of TORISEL is 25 mg infused over a 30 to 60 minute period once weekly. You may be given an antihistamine intravenously (into your vein) before your dose of TORISEL.
|In case of drug overdosage, contact a healthcare professional (e.g. doctor), hospital emergency department, or regional poison control centre, even if there are no symptoms.|
- Always take the labelled medicine bottle with you, even if it is empty.
If you are concerned that you may have missed a dose, tell your doctor immediately.
Side Effects and What to do About Them
Like all medicines, TORISEL can cause side effects, although not everybody gets them.
Very Common side effects of TORISEL occurring in more than 1 in 10 patients are
General feeling of weakness, swelling due to fluid retention, pain (including abdominal, back and chest pain), fever, nausea, anorexia, diarrhoea, vomiting, swelling and sores in the mouth and/or digestive tract, cough, low red blood cell count, sore throat, infections, high blood sugar, high cholesterol, joint pain, abscess, urinary tract infections, abnormal kidney function, shortness of breath, nose bleed, runny nose, rash, itching, nail disorder, acne, dry skin, change in the sense of taste, weight loss and sleeplessness.
Common side effects of TORISEL occurring in less than 1 out of 10 patients but more than 1 per 100 patients are
High blood pressure, stomach bloating, gum inflammation, mouth pain, redness and swelling of the tissues around the eye, blood tests which show changes in the way the liver is working, low levels of phosphate in the blood, low levels of potassium in the blood which may cause muscle weakness, twitching or abnormal heart rhythm, increased blood clotting (including thrombosis of the veins, embolism in the lung), upper respiratory infections, pneumonia, interstitial lung disease (inflammation or infection of the lungs), allergic (hypersensitivity) reactions, taste loss, inflammation of the follicles in the skin, decreased number of white blood cells, decreased number of lymphocytes and problems with healing after surgery.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Serious Side Effects, how Often They Happen and What to do About Them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking|
|Excessive thirst or frequency of urination suggestive of increased blood glucose levels||✓|
|Any fever, sweats or chills, or other symptoms suggestive of an infection||✓|
|Elevated triglycerides and/or cholesterol that may require reatment with lipid lowering agents||✓|
|Swelling or difficulty breathing suggestive of an allergic (hypersensitivity/ infusion) reaction||✓|
|Shortness of breath, cough, and fever suggestive of inflammation or infection of the lungs||✓|
|Decreased urine production, body swelling, fatigue, abdominal pain suggestive of kidney failure||✓|
|Stomach pain, nausea, or blood in the stool suggestive of lesions in the gastrointestinal tract (bowel perforation)||✓|
This is not a complete list of side effects. For any unexpected effects while taking TORISEL, contact your doctor or pharmacist.
How to Store It
Keep out of reach and sight of children.
Store in a refrigerator (2°C to 8°C).
Keep the vial in the outer carton in order to protect from light.
Do not use this medicine after the expiry date stated on the container.
Infusion solutions should be used up to 6 hours after dilution, and any unused medicine should be discarded.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada, at: 1-800-463-6001.