Temsirolimus

WHY is this medicine prescribed?

Temsirolimus is used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the kidney). Temsirolimus is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that tells the cancer cells to multiply. This may help slow the growth of tumors.

HOW should this medicine be used?

Temsirolimus comes as a solution (liquid) to be given by infusion (slow injection into a vein) over 30 to 60 minutes. It is usually given by a doctor or nurse in a doctor's office or infusion center. Temsirolimus is usually given once every week.

You may experience symptoms such as hives, rash, itching, difficulty breathing or swallowing, swelling of the face, flushing, or chest pain. Tell your doctor or other healthcare provider if you experience these symptoms while you are receiving temsirolimus. Your doctor may prescribe other medications to help prevent or relieve these symptoms. Your doctor will probably give you these medications before you receive each dose of temsirolimus.

What SPECIAL PRECAUTIONS should I follow?

Before taking temsirolimus,

• tell your doctor if you are allergic to temsirolimus, sirolimus, antihistamines, any other medications, polysorbate 80, or any of the ingredients in the temsirolimus solution. Ask your doctor for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); certain antifungal medications such as itraconazole (Sporanox); ketoconazole (Nizoral); and voriconazole (Vfen); clarithromycin (Biaxin); dexamethasone (Decadron); certain medications used to treat HIV/AIDS such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase); certain medications for seizures such as carbamazepine (Equetro, Tegretol), phenobarbital (Luminal),and phenytoin (Dilantin, Phenytek); medications to lower cholesterol and lipids; nefazodone; rifabutin (Mycobutin); rifampin (Rifadin, Rifamate, Rifiter); selective serotonin re-uptake inhibitors such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sirolimus (Rapamune, Rapamycin); sunitinib (Sutent); and telithromycin (Ketek). Many other medications may also interact with temsirolimus, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Also be sure to tell your doctor and pharmacist if you stop taking one of the medications listed above while you are receiving treatment with temsirolimus.

• tell your doctor what herbal products you are taking, especially St. John's Wort.

• tell your doctor if you have or have ever had diabetes, high cholesterol or triglycerides, a tumor in the central nervous system (brain or spinal cord), cancer, or kidney, liver, or lung disease.

• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving temsirolimus and for 3 months after treatment with temsirolimus has ended. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while taking temsirolimus, call your doctor immediately. Temsirolimus may harm the fetus.

• tell your doctor if you are breast-feeding. You should not breastfeed while receiving temsirolimus.

• you should know that you may be more at risk of getting an infection while you are receiving temsirolimus. Be sure to wash your hands frequently and avoid contact with people who are sick.

• do not have any vaccinations (e.g., measles, chicken pox, or flu shots) without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of temsirolimus, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Temsirolimus may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness
• swelling of the eyes, hands, feet, ankles, or lower legs
• headache
• itchy, watery, or red eye(s)
• change in the way things taste
• swelling, redness, pain, or sores inside the mouth or throat
• loss of appetite
• weight loss
• nausea
• vomiting
• constipation
• frequent need to urinate
• pain or burning during urination
• blood in the urine
• back pain
• muscle or joint pain
• bloody nose
• changes in fingernails or toenails
• dry skin
• pale skin
• excessive tiredness
• fast heart beat
• acne
• difficulty falling asleep or staying asleep
• depression

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• hives
• rash
• itching
• difficulty breathing or swallowing
• flushing
• chest pain
• shortness of breath
• fast breathing or panting
• leg pain, swelling, tenderness, redness, or warmth
• extreme thirst
• extreme hunger
• fever, sore throat, chills, cough, and other signs of infection
• fainting
• new or worsening abdominal pain
• diarrhea
• red blood in stools
• decrease in amount of urine
• blurred vision
• slow or difficult speech
• confusion
• dizziness or faintness
• weakness or numbness of an arm or leg

Temsirolimus may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

This medication will be stored at your doctor's office or clinic.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• seizure
• hallucinating (seeing things or hearing voices that do not exist)
• difficulty thinking clearly, understanding reality, or using good judgment
• cough
• shortness of breath
• fever
• new or worsening abdominal pain
• panting or fast breathing
• red blood in stools
• diarrhea
• leg pain, swelling, tenderness, redness, or warmth

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to temsirolimus.

Ask your doctor if you have any questions about your treatment with temsirolimus.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.