December 29, 2009


By Anonymous User

Class: Chemotherapy

Generic Name: Temozolomide (te-me-ZOE-le-mide)
Trade Name: Temodar®

How is this drug used? Temozolomide is FDA approved for the initial treatment of glioblastoma multiforme. The indication includes the use of temozolomide during treatment with radiation therapy, and followed by subsequent treatment with temozolomide alone. Temozolomide is also FDA approved for the treatment of anaplastic astrocytoma that has progressed following prior chemotherapy.  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 which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Temozolomide belongs to a group of drugs called alkylating agents.  Alkylating agents produce their anti-cancer effects by causing a chemical reaction that damages the DNA in a cell.  The DNA damage caused by temozolomide results in cellular death.

How is temozolomide given (administered)? Temozolomide is given by mouth, in the form of a capsule and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient. Do not open, crush or chew capsules. Take each day’s dose at one time with a full glass of water. The daily dose may be a combination of different sizes of capsules.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with temozolomide.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.  Although uncommon, patients are also monitored for an allergic-type reaction with temozolomide. Symptoms of an allergic-type reaction may include closing of throat, chills, difficulty breathing, hives, or redness of the face. If patients experience these side effects, they should contact their healthcare provider immediately.

What are the common (occur in 30% or more of patients) side effects of treatment with temozolomide?

• Nausea and vomiting
• Constipation
• Headache
• Generalized fatigue

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

• Low white blood cell levels – increases risk of infection
• Low red blood cell levels – increases risk of anemia
• Low platelet levels – increases risk of bleeding
• Swelling of feet and lower legs
• Dizziness
• Fever
• General weakness
• Weakness on one side of the body
• Diarrhea
• Coordination abnormalities
• Seizures

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 are the possible late side effects of treatment with temozolomide? Patients treated with temozolomide are at a slightly increased risk of developing a secondary malignancy.  A secondary malignancy is a new and unrelated cancer that occurs in an individual as a result of previous treatment with radiation or chemotherapy.  Patients should ask their physician about the possibility of developing a secondary malignancy as a result of their treatment.

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, patients should avoid large crowds or persons 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.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Eat small meals frequently to help alleviate nausea.

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.
• 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.
• Since problems with balance or dizziness, although uncommon, may be a side effect of treatment with temozolomide, patients should not drive or operate heavy machinery if experiencing these symptoms.
• If an oral dose is missed, do not double up on doses.  Patients should contact their doctor in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.

When should patients notify their physician?

• Swelling of feet and lower legs
• Rapid weight gain
• Central neurotoxicity characterized by dizziness, balance abnormalities, weakness on one side of body, seizures or excessive lethargy
• Persistent or extreme diarrhea or constipation
• Signs of a reaction to temozolimide - difficulty breathing, closing up of the throat, swelling of facial features, hives, redness of the face
• Flu or cold-like symptoms - fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness, painful urination
• Unexplained or excessive bleeding (nosebleeds, bruising, black tarry stools, blood in the urine, etc.)
• Persistent or severe fatigue
• Persistent or extreme nausea or vomiting
• Severe headache

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.

Copyright © 2010 CancerConsultants Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care

Tags: Chemotherapy, T