Generic Name: temozolomide (TEM oh ZOE loe mide)
Brand Names: Temodar

What is Temodar?

Temodar (temozolomide) interferes with the development of cancer cells, slowing their growth and spread in the body.

Temodar is used together with radiation therapy to treat certain types of brain tumor in adults. It is sometimes given after other cancer medications have been tried without successful treatment of the tumor.

Temodar may also be used for purposes not listed in this medication guide.

Important information

You should not take Temodar if you are allergic to temozolomide or to another cancer medication called dacarbazine (DTIC-Dome). Before taking Temodar, tell your doctor if you have liver or kidney disease.

Do not use Temodar if you are pregnant. It could harm the unborn baby.

Do not open the Temodar capsule, or use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if you accidentally inhale it, or if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

Slideshow: Flashback: FDA Drug Approvals 2013

Temodar is often given together with radiation treatment, and then continued for several weeks or months after radiation treatment ends. There may be periods of time when you will take Temodar for only a few days in a row and then wait another 2 to 4 weeks before you start a new treatment cycle and take it again. Follow your doctor's instructions 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 be different from time to time as your doctor adjusts your dose. Be sure you know the correct number of capsules to take and on which days to take them. Contact your doctor or pharmacist if you have any questions.

Taking Temodar may increase your risk of developing certain types of bone marrow cancer. Talk with your doctor about your individual risk.

Before taking this medicine

You should not take Temodar if you are allergic to temozolomide or to another cancer medication called dacarbazine (DTIC-Dome).

To make sure you can safely take Temodar, tell your doctor if you have any of these other conditions:

  • liver disease; or
  • kidney disease.

FDA pregnancy category D. 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. It is not known whether temozolomide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

Taking Temodar may increase your risk of developing certain types of bone marrow cancer. Talk with your doctor about your individual risk.

Women and older adults may be more likely to have bone marrow suppression (a weakened immune system) while taking Temodar. This can lead to an increased risk of infection or illness.

How should I take Temodar?

Take Temodar exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take Temodar on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the Temodar capsule whole, with a full glass of water.

If you vomit shortly after taking Temodar, do not take another capsule until it is time for your next regularly scheduled dose.

Do not open the Temodar capsule, or use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if you accidentally inhale it, or if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

You may be given other medications to prevent infection while you are taking Temodar. Use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

Temodar can lower blood cells that help your body fight infections. 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. Visit your doctor regularly.

Temodar is often given together with radiation treatment, and then continued for several weeks or months after radiation treatment ends. There may be periods of time when you will take Temodar for only a few days in a row and then wait another 2 to 4 weeks before you start a new treatment cycle and take it again. Follow your doctor's instructions 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 be different from time to time as your doctor adjusts your dose. Be sure you know the correct number of capsules to take and on which days to take them. Contact your doctor or pharmacist if you have any questions.

Store Temodar at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Taking Temodar for more than 5 days in a row can cause life-threatening overdose.

Overdose symptoms may include fever, pale skin, increased thirst, dry skin, easy bruising or bleeding, confusion, weakness, and urinating less than usual or not at all.

What should I avoid?

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.

Temozolomide can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up 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.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Temodar side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Temodar: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • seizure (convulsions);

  • numbness or tingling on one side of your body;

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, unusual weakness;

  • dry cough, feeling short of breath, weight loss, night sweats;

  • pain or burning when you urinate;

  • white patches or sores inside your mouth or on your lips; or

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Temodar side effects may include:

  • hair loss;

  • tired feeling;

  • diarrhea, constipation;

  • mild skin rash;

  • dizziness, blurred vision;

  • sleep problems (insomnia); or

  • unusual or unpleasant taste in your mouth.

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.

See also: Side effects (in more detail)

What other drugs will affect Temodar?

Tell your doctor about all other medicines you use, especially:

  • carbamazepine (Carbatrol, Equetro, Tegretol);

  • divalproex sodium (Depakote);

  • phenytoin (Dilantin);

  • valproic acid (Depakene, Stavzor);

  • steroids (prednisone and others); or

  • a sulfa drug such as Bactrim, Septra, Cotrim, or SMX-TMP.

This list is not complete and other drugs may interact with Temodar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Temodar.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 9.02. Revision Date: 2013-07-08, 11:40:29 AM.

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