SIDE EFFECTS: 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. People using this medication may 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, missed/heavy/painful periods. This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough). 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 rarely cause serious (rarely fatal) lung, kidney, or intestinal problems. Tell your doctor right away if you notice any symptoms of lung, kidney, or intestinal problems, including: shortness of breath, rapid breathing, cough, change in the amount of urine, frothy 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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. Temsirolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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 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 right away. 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 and for 3 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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 (such as benazepril, lisinopril), "blood thinners" (such as warfarin, enoxaparin), other drugs that weaken the immune system/increase the risk of infection (such as cyclosporine, natalizumab, rituximab, tacrolimus), sunitinib. Other medications can affect the removal of temsirolimus from your body, which may affect how temsirolimus works. Examples include azole antifungals (such as itraconazole, ketoconazole, voriconazole), enzalutamide, macrolide antibiotics (such as clarithromycin, erythromycin), mifepristone, HIV and HCV protease inhibitors (such as indinavir, ritonavir, telaprevir), rifamycins (such as rifampin, rifabutin), St. John's wort, among others. Temsirolimus is very similar to sirolimus. Do not use medications containing sirolimus while using temsirolimus.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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.