Posted on December 4th, 2008 by
Class: Biologic Therapy
Generic Name: Temsirolimus (tem-zi-ROLE-eh-mus)
Trade Name: Torisel™
For which conditions is this drug approved? Temsirolimus is FDA approved for the treatment of advanced renal cell carcinoma, the most common form of kidney cancer. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Temsirolimus is not a chemotherapy agent, but produces its anticancer effects by targeting and binding to a protein inside cells that inhibits the activity of mTOR (mammalian target of rapamycin). mTOR is involved in controlling cell division. By inhibiting mTOR, division of cancer cells may be reduced or prevented.
How is temsirolimus typically given (administered)? Temsirolimus is administered into a vein (intravenous). The dose depends on several factors, including the size of the patient, side effects caused by temsirolimus, and other medications being taken. Patients will receive medication to reduce the risk of an allergic reaction approximately 30 minutes prior to administration of temsirolimus.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with temsirolimus. Patients may undergo physical examination, scans or other measures to assess side effects and response to therapy. Patients will have blood drawn to measure levels of blood cells, particularly immune cells while on temsirolimus. Other measures of assessment may also be performed according to every patient’s individual needs and physicians’ discretion.
What are the common (occur in 30% or more of patients) side effects of treatment with temsirolimus?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with temsirolimus?
What are the side effects of temsirolimus that occur in less than 10% of patients?
What are the possible late side effects of treatment with temsirolimus? There is a slight chance that the addition of bevacizumab to chemotherapy may cause changes to heart function. Patients will have their heart function monitored prior to and during treatment with bevacizumab. Patients should discuss this potential side effect, although uncommon, with their physician.
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Are there any special precautions patients should be aware of before starting treatment?
Several different agents, including, but not limited to: proteasome inhibitors, St. Johns Wort, antifungals, antibiotics, anti-epileptic agents, selective serotonin re-uptake inhibitors, rifampicin, rafabutin, and nefazodone may inhibit effectiveness of temsirolimus.
When should patients notify their physician?
What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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