Temsirolimus (tem-sir-OH-li-mus)

Treats advanced kidney cancer.

Brand Name(s):

Torisel, temsirolimus

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. The medicine must be injected slowly, so your IV will need to stay in place for at least 30 minutes.
• You will receive an allergy medicine (eg, diphenhydramine, Benadryl®) 30 minutes before receiving the injection.
• 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.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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 any of the following:
  • Atazanavir, carbamazepine, clarithromycin, dexamethasone, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, phenobarbital, phenytoin, rifabutin, rifampicin, rifampin, ritonavir, saquinavir, St John's wort, sunitinib, telithromycin, voriconazole
  • Blood pressure medicine (including amlodipine, ramipril)
  • Blood thinner (including warfarin)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

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. Women should use an effective form of birth control during treatment with this medicine and for at least 3 months after your last dose. Male patients with female partners should use an effective form of birth control during treatment and for 3 months after the last dose.
• Do not breastfeed during treatment with this medicine and for 3 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, a bleeding disorder, a brain tumor, diabetes, high cholesterol, or any type of infection. 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 reaction
  • High blood sugar
  • High cholesterol in the blood
  • Increased risk of infections, including pneumonia
  • Interstitial lung disease (serious lung problem)
  • Bowel perforation (a hole in the bowel)
  • Increased risk of bleeding in the brain
  • Kidney disease (including kidney failure, proteinuria, nephrotic syndrome) that is not related to your kidney cancer
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may cause slow wound healing. You may need to stop taking it before 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.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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, red skin rash
• Change in how much or how often you urinate, painful urination, cloudy or bloody urine
• 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
• 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