TEMODAR is a brand name for the drug temozolomide, which is an alkylating agent. It is available in capsule form for oral use in dosage strengths of 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg, as well as for intravenous use as a 100 mg sterile lyophilized powder. The capsules contain inactive ingredients such as gelatin and pharmaceutical branding ink, and the injection formulation includes mannitol, L-threonine, and polysorbate 80, among others. TEMODAR is designed to be used orally and intravenously, with the prodrug temozolomide being rapidly converted to its active form in the body.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. You should always take it the same way. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose. If you vomit after a dose, do not take another until your next planned dose.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Fatigue
• Hair loss
• Headache
• Loss of appetite
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Liver disease
• An unusual or allergic reaction to temozolomide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Vaccines
• Valproic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You may need bloodwork while you are taking this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Call if you get diarrhea. Do not treat yourself. Try to avoid being around people who are sick.

Do not open the capsules of this medication. Breathing in or touching the powder in the capsule may be harmful. If the powder accidentally gets on your skin, wash the area thoroughly. If you have difficulty swallowing, contact your care team.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Do not become pregnant while taking this medication or for at least 6 months after stopping treatment. Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. Do not breast-feed while taking this medication or for at least 1 week after stopping treatment.

Do not father a child or donate sperm while taking this medication or for at least 3 months after stopping treatment. Contact your care team right away if your partner becomes pregnant.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.