Torisel IV

Pain/sores in the mouth or throat, nausea, vomiting, diarrhea, headache, changes in taste, weakness, and loss of appetite may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor right away if you have any serious side effects, including: flushing, slow wound healing, swelling ankles/feet, eye redness/itching, easy bruising/bleeding, unusual tiredness, muscle cramps, fast/pounding heartbeat, pain/redness/swelling of arms or legs.
This medication can lower the body\'s ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.
Temsirolimus may cause your cholesterol/triglycerides or blood sugar to increase. You may be required to have your cholesterol/triglycerides or blood sugar checked periodically. You may need medication to control your cholesterol/triglycerides or blood sugar. Tell your doctor or pharmacist if you experience symptoms of high blood sugar, including increased thirst/hunger, frequent urination.
This medication can infrequently cause serious (rarely fatal) lung, kidney, or intestinal problems. Tell your doctor immediately if you notice any symptoms of lung, kidney, or intestinal problems, including: shortness of breath, cough, change in the amount of urine, severe abdominal pain, black/bloody stool.
This drug increases the risk of a possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, difficulty speaking.
Infrequently a very serious allergic reaction to this drug might occur, especially while your dose is being given (infusion reaction). Get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash/flushing, itching/swelling (especially of the face/tongue/throat), severe dizziness, chest pain, trouble breathing.
Temsirolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving temsirolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, high cholesterol/triglyceride levels, liver disease, kidney disease, recent/current infections or wounds, recent surgery, brain cancer.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.
Before having surgery, tell your doctor or dentist that you are using this medication.
Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.
This drug is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. It is recommended that both men and women receiving this medication use at least 2 reliable forms of birth control (e.g., condoms, birth control pills) during treatment with this medication and for at least 3 months afterwards. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor immediately.
It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

See also How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.
Some products that may interact with this drug include: ACE inhibitors (e.g., lisinopril), \"blood thinners\" (e.g., warfarin, enoxaparin), drugs affecting liver enzymes that remove temsirolimus from your body (such as nefazodone, dexamethasone, St. John\'s wort, azole antifungals including itraconazole, macrolide antibiotics including erythromycin , HIV protease inhibitors including ritonavir, rifamycins including rifabutin, calcium channel blockers such as verapamil/nifedipine, certain anti-seizure medicines including carbamazepine/phenytoin/phenobarbital), drugs that may weaken the immune system (e.g., cyclosporine, sirolimus), sunitinib.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures, mental/mood changes, trouble breathing.

NOTES:
Laboratory and/or medical tests (such as complete blood count, cholesterol/triglyceride levels, blood glucose levels, liver/kidney function, chest X-ray) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

STORAGE:
Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
Information last revised August 2011. Copyright(c) 2011 First Databank, Inc.