Torisel™

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?

  • Rash
  • Nausea
  • Swelling
  • Increased sugar levels in the blood; decreased levels of phosphorus in blood
  • Loss of appetite and significant weight loss
  • Weakness, lack of energy
  • Mouth sores or mouth inflammation
  • Elevated cholesterol levels in the blood
  • Changes in levels of liver tests
  • Low levels of white blood cells
  • Low levels of platelets (thrombocytopenia)
  • Low levels of red blood cells (anemia)

What are the less common (occur in 10% to 29% of patients) side effects of treatment with temsirolimus?

  • Headache
  • Fever
  • Pain; chest pain; back pain; joint pain
  • Diarrhea
  • Vomiting
  • Low levels of potassium in the blood
  • Urinary tract infection
  • Infections
  • Swelling of the throat and nasal membranes
  • Constipation
  • Insomnia
  • Skin or nail disorders
  • Difficulty breathing/cough
  • Nosebleeds
  • Changes in taste

What are the side effects of temsirolimus that occur in less than 10% of patients?

  • Depression Low levels of platelets—increases risk of bleeding
  • Elevated bilirubin levels

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?

  • Pay careful attention to the physician’s instructions and inform the physician of any side effects.
  • Maintain adequate rest and nutrition.
  • Wear sunscreen and protective clothing and try to minimize sun exposure.
  • Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
  • If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
  • Wash hands often to reduce the risk of infection.
  • Eat small meals frequently to help alleviate nausea.
  • Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
  • For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.

Are there any special precautions patients should be aware of before starting treatment?

  • Patients should inform their physician if they are pregnant, breastfeeding, or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
  • It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
  • Temsirolimus may affect the effectiveness of vaccines. Avoid contact with other individuals who have recently received live vaccines.
  • Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
  • Patients should check with their physician before starting any new drug or nutritional supplement.
  • Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
  • Grapefruit or grapefruit juice may interfere with temsirolimus.

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?

  • New or worsening abdominal pain or blood in stool
  • Abnormal wound healing
  • Increase or severe headache
  • Sudden weight gain
  • Swelling of the ankles or feet
  • Pain in flank
  • Facial swelling
  • Continued or excessive nausea or vomiting
  • Excessive weight loss or inability to eat
  • Noticeable changes in heart rate or rhythm
  • Sores or pain in the mouth
  • Difficulty breathing
  • Continued or excessive diarrhea or constipation
  • Yellowing of the skin or eyes
  • Fever, cough, sore throat, aches, runny nose—signs of cold or flu
  • New or worsening respiratory symptoms (difficulty breathing, cough, wheezing)
  • Excessive thirst or urination

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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Tags: Biological Therapy, Drug Dictionary, T

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