Torisel 30 mg/3 mL (10 mg/mL) (first dilution) intravenous solution

Generic name:
Temsirolimus - injection

Pronunciation
(tem-sir-oh-LEE-muss)

Brand name(s)
Torisel

This medication is used to treat kidney cancer. It works by slowing or stopping the growth of cancer cells.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once a week (over 30 to 60 minutes). The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications (such as diphenhydramine) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as flushing, chest pain, shortness of breath, or dizziness. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also How to Use section.

Pain/sores in the mouth or throat, nausea, vomiting, diarrhea, headache, changes in taste, weakness, and loss of appetite may occur. If these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• flushing
• slow wound healing
• swelling ankles/feet
• eye redness/itching
• easy bruising/bleeding
• unusual tiredness
• muscle cramps
• fast/pounding heartbeat
• pain/redness/swelling of arms or legs
• missed/heavy/painful periods

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Temsirolimus may cause your cholesterol/triglycerides or blood sugar to increase. You may be required to have your cholesterol/triglycerides or blood sugar checked periodically. You may need medication to control your cholesterol/triglycerides or blood sugar. Tell your doctor or pharmacist if you experience symptoms of high blood sugar, including increased thirst/hunger, frequent urination.

This medication can rarely cause serious (rarely fatal) lung, kidney, or intestinal problems. Tell your doctor right away if you notice any symptoms of lung, kidney, or intestinal problems, including:

• shortness of breath
• rapid breathing
• cough
• change in the amount of urine
• frothy urine
• severe abdominal pain
• black/bloody stool

This drug increases the risk of a possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms:

• clumsiness
• sudden change in your thinking (such as confusion, difficulty concentrating)
• difficulty moving muscles
• seizure
• difficulty speaking

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

Temsirolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving temsirolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• high cholesterol/triglyceride levels
• liver disease
• kidney disease
• recent/current infections or wounds
• recent surgery
• brain cancer

Temsirolimus can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using temsirolimus before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using temsirolimus. Temsirolimus may harm an unborn baby. Men and women using this medication should ask about reliable forms of birth control during treatment and for at least 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 3 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• ACE inhibitors (such as benazepril, lisinopril)
• "blood thinners" (such as warfarin, enoxaparin)
• other drugs that weaken the immune system/increase the risk of infection (such as cyclosporine, natalizumab, rituximab, tacrolimus)
• sunitinib

Other medications can affect the removal of temsirolimus from your body, which may affect how temsirolimus works. Examples include azole antifungals (such as itraconazole, ketoconazole, voriconazole), enzalutamide, macrolide antibiotics (such as clarithromycin, erythromycin), mifepristone, HIV protease inhibitors (such as indinavir), rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, among others.

Temsirolimus is very similar to sirolimus. Do not use medications containing sirolimus while using temsirolimus.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: seizures, mental/mood changes, trouble breathing.

Lab and/or medical tests (such as complete blood count, cholesterol/triglyceride levels, blood glucose levels, liver/kidney function, chest X-ray, urine tests) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.