Temozolomide

Generic Name: temozolomide (TEM-oh-ZOL-oh-mide)
Brand Name: Temodar

Temozolomide is used for:

Treating certain types of brain tumors in certain patients. It may also be used for other conditions as determined by your doctor.

Temozolomide is an antineoplastic agent. It works by stopping cancer cells from growing and reproducing.

Do NOT use temozolomide if:

  • you are allergic to any ingredient in temozolomide, including if you have developed red, swollen, blistered, or peeling skin after taking a previous dose of temozolomide or oral temozolomide
  • you are allergic to dacarbazine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using temozolomide:

Some medical conditions may interact with temozolomide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have pneumonia, kidney, or liver problems
  • if you have bone marrow depression, including low white blood cell counts or low blood platelet levels

Some MEDICINES MAY INTERACT with temozolomide. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone) because the risk of severe infection may be increased
  • Valproic acid because it may increase the risk of temozolomide's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if temozolomide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use temozolomide:

Use temozolomide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with temozolomide. Talk to your pharmacist if you have questions about this information.
  • Temozolomide is usually given as an infusion at your doctor's office, hospital, or clinic. If you will be using temozolomide at home, a health care provider will teach you how to use it. Be sure you understand how to use temozolomide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use temozolomide if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of temozolomide, contact your doctor right away.

Ask your health care provider any questions you may have about how to use temozolomide.

Important safety information:

  • Temozolomide may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use temozolomide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Nausea, vomiting, and loss of appetite are common with temozolomide. Ask your doctor or pharmacist for ways to decrease these effects if they occur.
  • Temozolomide may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Temozolomide may increase your risk of developing a certain blood problem (myelodysplastic syndrome [MDS]) or a second cancer. Talk to your doctor if you have any questions or concerns.
  • Temozolomide may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Severe and sometimes fatal liver problems have happened in patients taking temozolomide. Tell your doctor right away if you develop symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness; yellowing of the skin or eyes).
  • This drug may lower the ability of your bone marrow to make blood cells that your body needs. A severe and sometimes fatal type of anemia has happened. Call your doctor right away if you have pale skin or feel very tired or weak.
  • Tell your doctor or dentist that you take temozolomide before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests may be performed while you use temozolomide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use temozolomide with caution in the ELDERLY; they may be more sensitive to its effects.
  • Men who take temozolomide should always use a condom when having sex with a woman who is pregnant or may become pregnant. Do this for as long as you take temozolomide.
  • PREGNANCY and BREAST-FEEDING: Temozolomide may cause harm to the fetus. Do not become pregnant while you are using it. Use an effective form of birth control while you are taking temozolomide. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using temozolomide while you are pregnant. It is not known if temozolomide is found in breast milk. Do not breast-feed while taking temozolomide.

Possible side effects of temozolomide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; back pain; breast pain; constipation; cough; diarrhea; dizziness; drowsiness; dry skin; hair loss; headache; joint pain; loss of appetite; mild stomach pain; mouth or tongue sores; muscle aches; nausea; taste changes; tiredness; trouble sleeping; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; coughing up blood; depression; difficulty swallowing; increased, difficult, or painful urination; fever, chills, or sore throat; loss of bladder control; loss of coordination; memory loss; muscle pain or weakness; numbness, burning, or tingling; pain, irritation, itching, warmth, swelling, or redness at the injection site; paralysis on one side of the body; persistent cough; red, swollen, peeling, or blistered skin; seizures; severe or persistent headache, nausea, or vomiting; shortness of breath; small red or purple spots under the skin; speech changes; sudden or unusual weight gain; swelling of the ankles, feet, or hands; unusual bruising or bleeding; trouble walking; vision changes (eg, blurred vision, double vision).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of temozolomide:

Temozolomide is usually handled and stored by a health care provider. If you are using temozolomide at home, store temozolomide as directed by your pharmacist or health care provider. Keep temozolomide out of the reach of children and away from pets.

General information:

  • If you have any questions about temozolomide, please talk with your doctor, pharmacist, or other health care provider.
  • Temozolomide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take temozolomide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about temozolomide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to temozolomide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using temozolomide.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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