Temozolomide (oral/injection)

Temozolomide is used along with radiation therapy to treat specific types of brain tumor in adults.

Temozolomide is typically given after other treatments have not worked.

Temozolomide may also be used for reasons not mentioned in this medication guide.

Call your doctor if you have a fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed, or short of breath.

You should not use temozolomide if you are allergic to temozolomide or dacarbazine.

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.

Temozolomide can harm an unborn baby if the mother or the father is using this medicine.

• 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.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Temozolomide may cause serious side effects. Call your doctor right away if you have:

• 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 of temozolomide 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 can report side effects to FDA at 1-800-FDA-1088.

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.

Take your entire daily dose of the capsules at the same time on each dosing day of a treatment cycle. Swallow the capsules whole with a full glass of water.

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

You may need to take temozolomide temozolomide capsule at bedtime or on an empty stomach if the medicine upsets your stomach.

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

Do not use an open capsule. If the medicine from a broken pill gets in your mouth, eyes, or nose, or on your skin, wash with soap and water (or rinse eyes with water). Ask your pharmacist how to safely dispose of a broken pill.

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.

Store temozolomide capsule at room temperature away from moisture and heat.

Call your doctor for instructions if you miss a dose of temozolomide.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Stay away from people who are sick or have infections. Inform your doctor immediately if you notice any signs of infection.

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

Steer clear of activities that could raise your risk of bleeding or injury. Be extra cautious when shaving or brushing your teeth.

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.