Uses of Temodar:

• It is used to treat brain cancer.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Temodar?

• If you are allergic to Temodar (temozolomide capsules); any part of Temodar (temozolomide capsules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed while you take Temodar (temozolomide capsules) and for 1 week after your last dose.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Temodar (temozolomide capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Temodar?

• Tell all of your health care providers that you take Temodar (temozolomide capsules). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Temodar (temozolomide capsules) may either raise the chance of an infection or make the vaccine not work as well.
• If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Low blood cell counts have happened with Temodar (temozolomide capsules). If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. Sometimes, these have been deadly. If you have questions, talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• A very bad bone marrow problem and second cancer have happened with Temodar (temozolomide capsules). Talk with the doctor.
• If you are 70 years or older, use Temodar (temozolomide capsules) with care. You could have more side effects.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Temodar (temozolomide capsules) to show that you are NOT pregnant.
• Women must use birth control while taking Temodar (temozolomide capsules) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking Temodar (temozolomide capsules) and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.
• This medicine may affect being able to father a child. Talk with the doctor.
• This medicine is found in semen. Do not donate semen while you take Temodar (temozolomide capsules) and for 3 months after your last dose.

How is this medicine (Temodar) best taken?

Use Temodar (temozolomide capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Temodar (temozolomide capsules) at the same time of day.
• Take with or without food but take the same way each time. Always take with food or always take on an empty stomach.
• Taking Temodar (temozolomide capsules) on an empty stomach may help prevent upset stomach. It may also help to take Temodar (temozolomide capsules) at bedtime. Talk with the doctor.
• Other drugs may be given with Temodar (temozolomide capsules) to help avoid side effects.
• Take with a full glass of water.
• Swallow whole. Do not chew, open, or crush.
• Keep taking Temodar (temozolomide capsules) as you have been told by your doctor or other health care provider, even if you feel well.
• The dose you get may be made up of 2 or more different strengths and colors of capsules.
• If you throw up after taking Temodar (temozolomide capsules), do not repeat the dose.
• You will need to take special care when handling Temodar (temozolomide capsules). Check with the doctor or pharmacist to see how to handle Temodar (temozolomide capsules).
• Wear gloves when touching Temodar (temozolomide capsules).
• If the capsule is opened or broken, do not touch the contents. If the contents are touched or they get in the eyes, wash hands or eyes right away.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Any unexplained bruising or bleeding.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Feeling confused.
• Mood changes.
• Trouble swallowing.
• Not able to control bladder.
• Memory problems or loss.
• A burning, numbness, or tingling feeling that is not normal.
• Seizures.
• Change in eyesight.
• Pinpoint red spots on the skin.
• Breast pain.
• Very bad and sometimes deadly liver problems have happened with Temodar (temozolomide capsules). Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Temodar?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hair loss.
• Headache.
• Feeling dizzy, sleepy, tired, or weak.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Trouble sleeping.
• Back, muscle, or joint pain.
• Dry skin.
• Change in taste.
• Weight gain.
• Signs of a common cold.
• Mouth irritation or mouth sores.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Temodar?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Temodar (temozolomide capsules), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.