Temodar (Temozolomide)

You should not take this medicine if you are allergic to TEMODAR or to another cancer medication called dacarbazine (DTIC).

To make sure TEMODAR is safe for you, tell your doctor if you have:

• liver disease; or
• kidney disease.

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

Do not use TEMODAR if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are receiving TEMODAR, whether you are a man or a woman. TEMODAR use by either parent may cause birth defects.

It is not known whether TEMODAR passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

Call your doctor at once if you have:

• seizure (convulsions);
• fever, chills, dry cough, feeling short of breath;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• bruising, skin rash;
• loss of movement on one side of the body;
• nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• headache, tired feeling, memory problems;
• dizziness, weakness, loss of coordination;
• sleep problems (insomnia);
• 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.

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

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

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with TEMODAR, especially:

• steroid medicine (dexamethasone, prednisone, and others); or
• valproic acid (Depakene, Stavzor).

This list is not complete. Other drugs may interact with TEMODAR, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Your doctor may occasionally change your dose to make sure you get the best results. The size, color, and number of TEMODAR 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.

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

Take this medicine at the same time each day.

You may need to take TEMODAR 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 open the TEMODAR capsule. Do not use a broken pill. The medicine from an open or broken capsule can be dangerous if it gets in your mouth or nose, or on your skin. If this occurs, rinse thoroughly with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

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

TEMODAR can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often.

Tell your doctor if you have any changes in height or weight. TEMODAR doses are based on body surface area (height and weight), and any changes may affect your dose.

Your doctor will need to check your progress while you are using TEMODAR.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line.

Taking TEMODAR for more than 5 days in a row can cause a life-threatening overdose.

Overdose can cause severe forms of some of the side effects listed in this medication guide.

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