temozolomide

What is the most important information I should know about temozolomide?

What is temozolomide?

Temozolomide is used together with radiation therapy to treat certain types of brain tumor in adults.

Temozolomide is usually given after other treatments have failed.

Temozolomide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking temozolomide?

Tell your doctor if you have ever had:

• liver disease; or
• kidney disease.

Using temozolomide may increase your risk of developing certain types of bone marrow cancer. Ask your doctor about your specific risk.

You may need to have a negative pregnancy test before starting this treatment.

• If you are a woman, do not use temozolomide if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using temozolomide.

This medicine may affect fertility (ability to have children) in men. Talk to your doctor about your own risk.

How should I take temozolomide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Temozolomide is given in a 28-day treatment cycle, and you may only need to take the medicine during the first few days of each cycle.

If you are also receiving radiation treatment, you may need to take temozolomide for 6 to 7 weeks in a row during your first treatment cycle. Then you may be switched to a 28-day maintenance treatment cycle.

Your doctor may occasionally change your dose to make sure you get the best results. The size, color, and number of temozolomide capsules you take may sometimes be different from earlier treatment cycles. Be sure you know the correct number of capsules to take and on which days to take them. Ask your doctor or pharmacist if you have any questions.

Temozolomide doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight or if you are still growing.

Take this medicine at the same time each day.

You may take temozolomide with or without food, but take it the same way each time.

Your doctor will determine how long to treat you with temozolomide. Follow your doctor's dosing instructions very carefully.

If you vomit shortly after taking the medicine, do not take another capsule until your next regularly scheduled dose.

You may be given medication to prevent nausea or other side effects while you are receiving temozolomide.

Temozolomide can increase your risk of bleeding or infection. You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

Your liver function may also need to be checked during treatment and for 2 to 4 weeks after you stop using this medicine.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking temozolomide?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Men should not donate semen while using temozolomide and for at least 90 days after the last dose.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What are the possible side effects of temozolomide?

• a seizure (convulsions);
• sudden chest pain or discomfort, wheezing, dry cough;
• low blood cell counts --fever, chills, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, vomiting, loss of appetite;
• skin rash;
• loss of movement on one side of the body;
• diarrhea, constipation;
• headache, feeling tired, memory problems;
• dizziness, weakness, loss of coordination;
• sleep problems (insomnia);
• seizure;
• low white blood cell counts (fever, flu symptoms); or
• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect temozolomide?

Tell your doctor about all your other medicines, especially:

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection; or
• valproic acid (Depakene, Stavzor).

This list is not complete. Other drugs may affect temozolomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about temozolomide.