When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not receive it if you are pregnant or have severe liver disease.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how temsirolimus works. Tell your doctor if you are using atazanavir, carbamazepine, clarithromycin, dexamethasone, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenobarbital, phenytoin, rifabutin, rifampicin, rifampin, ritonavir, saquinavir, St John's wort, telithromycin, voriconazole, or a blood thinner (such as warfarin).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control while you are being treated and for at least 3 months after you stop treatment.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, a bleeding disorder, a brain tumor, diabetes, high cholesterol, an infection, or lung disease. Tell your doctor if you had an allergic reaction to temsirolimus, sirolimus, or polysorbate 80 (a preservative).
• This medicine may cause the following problems:
  
  • Infusion reactions
  • High blood sugar
  • Higher risk of infections, including pneumonia
  • Interstitial lung disease (serious lung problem)
  • Bowel perforation (a hole in the bowel)
  • Kidney disease that is not related to your kidney cancer
• This medicine may affect the way your body heals from cuts and wounds. Tell any doctor who treats you that you are using this medicine. You may need to stop using this medicine before and after you have surgery.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Change in how much or how often you urinate, painful urination
• Chest pain, trouble breathing
• Fever, chills, cough, lightheadedness
• Increased hunger or thirst
• Severe stomach pain, vomiting blood or material that looks like coffee grounds, red or black stools
• Sores or white patches on your lips, mouth, or throat
• Swelling in your face, hands, or feet

If you notice these less serious side effects, talk with your doctor:

• Back or joint pain
• Change in taste, loss of appetite
• Diarrhea, constipation, nausea, vomiting, or mild stomach pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088