Temsirolimus

Temsirolimus is used to treat cancer of the kidneys, also known as renal cell carcinoma.

Temsirolimus may also be used for reasons not mentioned in this medication guide.

Temsirolimus is given as an infusion into a vein. A healthcare provider will give you this injection.

Temsirolimus is usually given once each week unless your cancer gets worse or you have serious side effects from this medicine. This medicine must be given slowly, and the infusion can take up to 60 minutes to complete.

You may be given other medication to prevent an allergic reaction to temsirolimus.

You may need frequent medical tests to make sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

If you need surgery, tell the surgeon ahead of time that you are using temsirolimus.

You should not use temsirolimus if you have severe liver disease.

You should not use temsirolimus if you have severe liver disease.

Tell your doctor if you have ever had:

• liver disease;
• kidney disease;
• high cholesterol or triglycerides (a type of fat in the blood);
• diabetes;
• a head injury or brain tumor; or
• an allergy to temsirolimus or sirolimus (Rapamune).

Both men and women using temsirolimus should use effective birth control to prevent pregnancy. Temsirolimus can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 3 months after your last dose of temsirolimus. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using temsirolimus.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because temsirolimus can harm an unborn baby.

You should not breastfeed while using this medicine and for at least 3 weeks after your last dose.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may happen during the injection. Tell your caregiver right away if you feel dizzy, warm, tingly, light-headed, or short of breath.

Temsirolimus may cause serious side effects. Call your doctor immediately if you have:

• cough, chest pain, wheezing, trouble breathing;
• stomach pain, bloody or tarry stools;
• pain or burning when you urinate, blood in your urine;
• a surgical incision that will not heal;
• low blood cell counts—fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• high blood sugar—increased thirst, increased urination, dry mouth, fruity breath odor;
• kidney problems—little or no urination, puffy eyes, swelling in your feet or ankles, weight gain, urine that looks foamy; or
• low potassium level—leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or feeling limp.

Side effects like diarrhea, swelling, and breathing problems may be more likely in older adults.

Common side effects of temsirolimus may include:

• low blood cell counts;
• feeling weak or tired;
• mouth sores or ulcers;
• nausea, vomiting, stomach pain, loss of appetite;
• swelling;
• headache, joint pain;
• rash; or
• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Renal Cell Carcinoma:

25 mg IV infusion over a 30 to 60 minute period once a weekDuration of therapy: Treat until disease progression or unacceptable toxicityComments: IV diphenhydramine 25 to 50 mg (or similar antihistamine) should be given approximately 30 minutes before the start of each doseUse: Advanced renal cell carcinoma

Call your doctor if you miss an appointment for your Temsirolimus injection.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include problems breathing, confusion, seizures, or bloody stools.

Grapefruit may interact with temsirolimus and cause unwanted side effects. Avoid grapefruit products.

Do not get a "live" vaccine while using temsirolimus. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and the nasal flu (influenza) vaccine.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Tell your doctor about all the medications you are currently taking. Many drugs can affect temsirolimus, especially:

• sunitinib;
• St. John's Wort;
• an antibiotic or antifungal medicine;
• an antidepressant;
• antiviral medicine to treat hepatitis C or HIV/AIDS;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medicine, especially an ACE inhibitor or calcium channel blocker (such as amlodipine, benazepril, diltiazem, ramipril, verapamil, and many others);
• insulin or oral diabetes medicine; or
• seizure medicine.

This list is not complete, and many other drugs may affect temsirolimus. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.