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Temsirolimus

(tem-suh-role-uh-muss)

Trade/other name(s): Torisel, CCI-779

Why would this drug be used?

This drug is used to treat advanced kidney cancer. It is also being studied for use against a number of other cancers.

How does this drug work?

Temsirolimus is a type of targeted therapy that blocks mTOR, a protein in cells that normally promotes their growth and division. By blocking this protein, temsirolimus can help stop the growth of cancer cells.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have diabetes. Temsirolimus may raise blood sugar levels. You and your doctor will want to watch this closely during treatment.
  • If you have any type of liver disease (including hepatitis). This drug is cleared from the body mainly by the liver. Reduced liver function might result in more of the drug staying in the body than expected, which could lead to unwanted side effects. Your doctor may need to adjust your dose accordingly.
  • If you have ever had high cholesterol. Temsirolimus may raise blood levels of cholesterol.
  • If you have any type of kidney disease. Temsirolimus may affect the kidneys, which in some cases can be serious. Your doctor will probably want to watch this closely during treatment.
  • If you have any other medical conditions such as heart disease, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you have recently had or are scheduled to have surgery. Temsirolimus may delay the time it takes for wounds to heal or cause healing wounds to re-open.
  • If you take any type of blood-thinning medicines, such as aspirin or warfarin (Coumadin). Temsirolimus may increase the risk of bleeding in the brain in people taking these drugs.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug can cause problems with the fetus if taken at the time of conception or during pregnancy. Men and women who are taking this drug should use some kind of birth control during treatment and for at least 3 months afterward. Check with your doctor about what kinds of birth control can be used with this medicine. In pregnant women, treatment with this drug should be used only if the potential benefit to the mother outweighs the risk to the fetus.
  • If you are breast-feeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Breast-feeding is not recommended during treatment with this drug.
  • If you think you might want to have children in the future. This drug may affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

This drug can interact with a number of drugs and supplements. Some cause the drug's breakdown products to build up in your blood, and can worsen side effects and other problems:

  • anti-depressant drugs nefazodone (Serzone), fluvoxamine (Luvox), fluoxetine (Prozac, Serafem)
  • antibiotics erythromycin, clarithromycin, telithromycin, and similar drugs
  • anti-fungal antibiotics such as ketoconazole, itraconazole, and voriconazole
  • the anti-nausea drug aprepitant
  • certain blood pressure medicines such as diltiazem and verapamil
  • HIV drugs such as indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, and others
  • St. John's wort (an herbal dietary supplement)
  • Other drugs may lessen the actions of temsirolimus so that it doesn't work as well:
  • anti-seizure drugs carbamazepine, phenobarbital, and phenytoin
  • rifampin and rifabutin (TB drugs)
  • steroid drugs such as dexamethasone

Don't start or stop taking any drugs while you are taking temsirolimus without talking with your doctor first. Your dose of temsirolimus may need to be adjusted before or after the change.

Sunitinib (Sutent) can cause gout, rash, and other serious skin problems if given with temsirolimus.

Any drugs or supplements that interfere with blood clotting can raise the risk of bleeding during treatment with temsirolimus. These include:

  • vitamin E
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and many others
  • warfarin (Coumadin)
  • ticlopidine (Ticlid)
  • clopidogrel (Plavix)

Note that many cold, flu, fever, and headache remedies contain aspirin or ibuprofen. Ask your pharmacist if you aren't sure what's in the medicines you take.

Check with your doctor, nurse, or pharmacist about any other medicines, herbs, and supplements you are taking, and ask if alcohol can cause problems with this medicine.

Interactions with foods

Grapefruit or grapefruit juice may change the level of temsirolimus in your blood. Check with your doctor, nurse, or pharmacist about whether these or other foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Temsirolimus is given by an infusion into a vein (IV), usually over a 30 to 60 minute period, once a week. In some cases (such as if you have low blood cell counts), the dose may need to be changed or the drug not given for a time.

You will likely get an antihistamine such as diphenhydramine (Benadryl) about half an hour before each infusion to lessen the chance you will have an allergic reaction to this drug.

Precautions

This drug may interact with a number of other drugs or supplements in the body. (See "Interactions with drugs" above.) Be sure your doctor is aware of all drugs and supplements you are taking. Do not start or stop taking any drug without checking with your doctor.

This drug can cause allergic reactions in some people when it is given. While you will probably be given medicine ahead of time to lower this risk, reactions are still possible. Mild reactions may consist of fever, chills, skin itching, or feeling flushed. More serious reactions happen rarely, but can be dangerous. Symptoms can include feeling lightheaded or dizzy (due to low blood pressure), chest tightness or pain, trouble breathing, back pain, or swelling of the face, tongue, or throat. Tell your doctor or nurse right away if you notice any of these symptoms during or after being given the drug.

Temsirolimus may raise your blood sugar (glucose) levels. Tell your doctor if you start feel thirsty and hungry all the time or have to pass urine more often than normal. Your doctor may check your blood sugar levels while you are taking this drug.

This drug may also raise your blood cholesterol levels. Your doctor will likely check these levels before treatment, and may advise you to start taking medicine (or increase your current doses) to offset this.

This drug may cause kidney damage that in rare cases can be life-threatening. Your doctor may check your blood while you are taking this drug to try and detect any kidney problems before they become serious.

In rare cases, this drug can cause a hole (perforation) in the intestines. It is important to tell your doctor or nurse right away if you develop severe stomach (abdominal) pain, whether or not you have nausea, diarrhea, fever, constipation, or other symptom with it.

This drug may affect your body's ability to heal wounds. Be sure your doctor knows if you have had surgery within the past few weeks or are scheduled for any surgery in the near future.

In rare cases, patients have developed severe lung disease during treatment. Your doctor may x-ray your chest before you start the drug, and check your lungs regularly even if you don’t notice any problems. Be sure to tell your doctor right away if you notice any breathing problems or lung problems, such as wheezing, shortness of breath, or a new cough.

In rare cases when people have brain tumors or are taking blood-thinning medicines, this drug may cause bleeding in the brain, a type of stroke. Speak with your doctor before taking any drugs or supplements that might affect your body's ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Get emergency help if you notice trouble speaking, trouble moving any part of your body, numbness or weakness of an arm or leg, or confusion.

Your doctor will likely test your blood throughout your treatment, looking for possible effects of the drug on blood counts or on blood chemistry levels. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether. Be sure to keep all appointments for lab tests and doctor visits.

This drug may lower your white blood cell counts, which can increase your chance of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5° or higher), chills, pain when passing urine, new onset of cough, or bringing up sputum (phlegm).

Do not get any immunizations (vaccines), either during or after treatment with this drug, without your doctor's OK. Temsirolimus may affect your immune system. This could make vaccinations ineffective, or even lead to serious infections if you get a live virus vaccine during or soon after treatment. Try to avoid people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine. Check with your doctor about this.

Men and women should avoid conceiving a baby during treatment and for at least 3 months afterward. Talk with your doctor about this.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • skin rash
  • feeling weak
  • nausea
  • mouth sores
  • loss of appetite
  • swelling in the hands or feet
  • low red blood cell counts
  • low white blood cell counts, with increased risk of infection*
  • high blood sugar levels*
  • high blood cholesterol levels*
  • abnormal blood test results suggesting drug may be affecting the liver or kidneys (Your doctor will discuss the importance of this finding, if any.)

Less common

  • fever, chills
  • weight loss
  • headache
  • altered taste or loss of taste
  • vomiting
  • diarrhea
  • constipation
  • pain in the chest, abdomen (belly), or back*
  • joint or muscle pain
  • shortness of breath
  • cough
  • infection*
  • problems with fingernails or toenails
  • dry skin
  • dry eyes
  • trouble sleeping
  • high blood pressure

Rare

  • blood clots in the legs or lungs
  • allergic reaction, with headache, chest pain, wheezing, sweating, or chills*
  • slow healing of a wound or surgical incision (or re-opening of one that is healing)*
  • lung disease such as pneumonitis*
  • bleeding in the brain (stroke)*
  • kidney damage or kidney failure*
  • damage to the lungs*
  • hole in the intestines (bowel perforation)*
  • death due to stroke, bowel perforation, kidney failure, severe lung disease, or other cause

*See the "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2007.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 02/22/2010
Last Revised: 07/20/2011