What is Temozolomide?

Temozolomide is used to treat specific types of brain cancer (eg, glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed. It belongs to the group of medicines known as antineoplastics (cancer medicines).

Temozolomide interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells may also be affected by temozolomide, other side effects may occur. Some of these may be serious and must be reported to your doctor. Some side effects may not occur for months or years after the medicine is used.

Before you begin treatment with temozolomide, you and your doctor should talk about the risks and benefits of this medicine.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not take more or less of it and do not take it for a longer time than directed. To do so may increase the chance of unwanted side effects.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine at the same time each day, either with or without food.

Temozolomide often causes nausea and vomiting. However, it is very important that you continue to take the medicine, even if you begin to feel ill. Taking the medicine on an empty stomach or at bedtime may help to lessen the nausea. Ask your doctor for other ways to help lessen these effects.

Swallow the capsules whole with a full glass of water. Do not be crush, break, chew, or open it. If the capsule is opened accidentally, do not allow the powder to contact your skin, mouth, or nose. Be careful not to inhale the contents of the capsule.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For newly diagnosed glioblastoma multiforme:
    • Adults—Dose is based on body size and must be determined by your doctor. The dose is usually 75 milligrams (mg) per square meter (m[2]) of body size given as a single dose for 42 days. This is given together with a radiation treatment followed by a maintenance treatment for 6 cycles. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For refractory anaplastic astrocytoma:
    • Adults—Dose is based on body size and must be determined by your doctor. The starting dose is usually 150 milligrams (mg) per square meter (m[2]) of body size once a day for 5 days, and then you stop taking it for the next 23 days. This dose cycle may be repeated every 28 days, for up to 2 years. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Call your doctor or pharmacist for instructions.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of temozolomide in the pediatric population. Safety and efficacy have not been established. .

Although appropriate studies on the relationship of age to the effects of temozolomide have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of temozolomide in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving temozolomide.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Yellow Fever Vaccine

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (eg, anemia, leukemia, myelodysplastic syndrome, pancytopenia, thrombocytopenia) or
• Liver problems—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—May increase risk of severe disease affecting other parts of the body.

• Kidney disease, severe or
• Liver disease, severe—Use with caution.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Temozolomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.