Temsirolimus Solution for injection

What is this medicine?

TEMSIROLIMUS (TEM sir OH li mus) is a drug that alters immune system response in the body. It is used to treat renal cell cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease

• high cholesterol

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• lung or breathing disease, like asthma

• take medicines that treat or prevent blood clots

• an unusual or allergic reaction to temsirolimus, polysorbate 80, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• grapefruit juice

• St. John's Wort

This medicine may also interact with the following medications:

• carbamazepine

• dexamethasone

• nefazodone

• phenobarbital

• phenytoin

• medicines for heart or kidney problems like captopril, lisinopril

• medicines for infection like clarithromycin, itraconazole, ketoconazole, rifabutin, rifampin, telithromycin

• some medicines for HIV like atazanavir, indinavir, nelfinavir, ritonavir, saquinavir

• sunitinib

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check-ups. you will need important blood work done while you are taking this medicine.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Women who are able to have children should use effective birth control before, during, and for 12 weeks after stopping this medicine. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems, cough

• chest pain

• dizziness

• fever or chills, sore throat

• hallucination, loss of contact with reality

• increased hunger or thirst

• increased urination

• pain, swelling, warmth in the leg

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures

• swelling of the legs or ankles

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• constipation

• loss of appetite

• mouth sores

• nausea, vomiting

• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.