Temsirolimus, Infusion

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KEY POINTS

• This medicine is given by IV to treat kidney cancer.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause bleeding problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: temsirolimus, infusion; Torisel

What is this medicine used for?

This medicine is used to treat advanced renal cell carcinoma (kidney cancer).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or preservative
• A blood or bone marrow disorder
• Cancer in the brain or spine
• Diabetes
• High cholesterol or high triglycerides
• Liver or kidney disease
• Lung disease

Also tell your provider if you have any kind of infection or if you are scheduled to have any kind of surgery in the near future.

Men should use effective birth control during treatment and for at least 3 months after the last dose because this medicine may affect the sperm and lead to birth defects.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine and for at least 3 months after treatment has stopped. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

This medicine is given by IV infusion (slow drip through a needle into a large vein) by your healthcare provider.

You will be given a medicine such as diphenhydramine (Benadryl) to prevent allergic reactions before you receive this medicine.

What should I watch out for?

This is a very strong medicine. It should only be given where you can be monitored closely. You need to have lab tests and chest X-rays to see how the medicine is affecting you. Keep all appointments.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Your healthcare provider may prescribe other medicine to prevent infection while you are receiving this medicine. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may cause bleeding in the brain, bleeding in the bowels, and slow wound healing. Do not drink alcohol or take aspirin while receiving this medicine unless your healthcare provider approves. It may increase the risk of bleeding.

This medicine may cause a serious lung disease. Tell your provider if you have new symptoms such as shortness of breath, cough, or fever.

Adults over the age of 65 may be at greater risk for side effects.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may increase the risk of developing diabetes. If you have diabetes, this medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider before you change your diet or dosage of diabetes medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fever, chills, cough, shortness of breath, chest pain, unusual bruising or bleeding, yellowing of your skin or eyes, black tarry bowel movements, increased thirst, increased urination, severe stomach pain, mouth sores, blood in your urine, painful urination, dizziness, confusion, unexplained swelling.

Other: Joint or muscle pain, back pain, nausea, vomiting, diarrhea, constipation, sore throat, runny nose, loss of appetite, trouble sleeping, dry skin, minor rash or itching, nail changes, change in sense of taste, depression.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, metronidazole, rifabutin (Mycobutin), rifampin (Rifadin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, desipramine (Norpramin), fluoxetine (Prozac), fluvoxamine (Luvox), mirtazapine (Remeron), nefazodone, sertraline (Zoloft), and venlafaxine (Effexor)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenytoin, primidone (Mysoline), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend) and fosaprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Cimetidine (Tagamet)
• Corticosteroids such as betamethasone (Celestone), dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Everolimus (Afinitor, Zortress)
• Haloperidol (Haldol)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, rivaroxaban (Xarelto), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer) and macitentan (Opsumit)
• Natural remedies such as angelica, anise, arnica, asafoetida, capsicum, celery, chamomile, clove, echinacea, fenugreek, garlic, ginger, ginkgo, ginseng, horse chestnut, licorice, papain, passionflower, red clover, St. John's wort, turmeric, and willow
• Other cancer medicines such as ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), doxorubicin (Doxil), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), tamoxifen, trastuzumab (Herceptin), and vemurafenib (Zelboraf)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Vaccines

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.