temozolomide (oral/injection)

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 using 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.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• If you are a man, use 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.

It may be harder for a man to get a woman pregnant while using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

How should I use 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 only on certain days of this cycle.

Your doctor may occasionally change your dose. 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.

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

Temozolomide injection is given by a healthcare provider. The medicine is injected slowly into a vein, over 90 minutes.

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

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.

Your blood will need to be tested often and your dose or medication schedule may be changed 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 using 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 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, constipation;
• headache, feeling tired;
• seizure;
• bruising, purple spots;
• pain, itching, warmth, redness, swelling, or irritation where the medicine was injected; 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.