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temozolomide

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

What is temozolomide?

Temozolomide interferes with the development of cancer cells, slowing their growth and spread in the body.

Temozolomide is used together with radiation therapy to treat certain types of brain tumor in adults.

Temozolomide is sometimes given after other cancer medications have been tried without successful treatment of the tumor.

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

What is the most important information I should know about temozolomide?

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

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

Do not open the temozolomide 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.

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

What should I discuss with my healthcare provider before taking temozolomide?

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

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

  • liver disease; or

  • kidney disease.

FDA pregnancy category D. Do not use temozolomide 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.

Taking temozolomide 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 temozolomide. This can lead to an increased risk of infection or illness.

How should I take temozolomide?

Take 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 temozolomide on an empty stomach, at least 1 hour before or 2 hours after a meal.

Swallow the temozolomide capsule whole, with a full glass of water.

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

Do not open the temozolomide 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 temozolomide. 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.

Temozolomide 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.

Temozolomide 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 temozolomide 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 temozolomide 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 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 temozolomide 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 while taking temozolomide?

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 (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.

Temozolomide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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)

Temozolomide dosing information

Usual Adult Dose for Anaplastic Astrocytoma:

For the treatment of adult patients with refractory anaplastic astrocytoma:

Initial dose: 150 mg/m2 either orally or by intravenous infusion over 90 minutes once daily for 5 consecutive days per 28 day treatment cycle

If the nadir and day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil counts (ANC) are greater than or equal to 1.5 × 10(9)/L and the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 × 10(9)/L, the dose may be increased to 200 mg/m2/day for 5 consecutive days per 28 day treatment cycle.

During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 10(9)/L and the platelet count exceeds 100 × 10(9)/L. The next cycle of temozolomide should not be started until the ANC and platelet count exceed these levels.

If the ANC falls to less than 1.0 × 10(9)/L or the platelet count is less than 50 × 10(9)/L during any cycle, the next cycle should be reduced by 50 mg/m2, but not below 100 mg/m2 , the lowest recommended dose.

Usual Adult Dose for Glioblastoma Multiforme:

For patients with newly diagnosed high grade glioma:

Initial dose: 75 mg/m2 daily either orally or by intravenous infusion over 90 minutes for 42 days concomitant with focal radiotherapy (RT).

The initial dose is followed my maintenance temozolomide for 6 cycles. No dose reductions are recommended during the concomitant phase. However, dose interruptions or discontinuation may occur based on toxicity. The dose should be continued throughout the 42 day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count (ANC) greater than or equal to 1.5 x 10(9)/L, platelet count greater than or equal to 100 x 10(9)/L, common toxicity criteria (CTC) nonhematologic toxicity less than or equal to grade 1 (except for alopecia, nausea, and vomiting). During treatment, a complete blood count should be obtained weekly. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematologic and nonhematologic toxicity criteria as noted below. Pneumocystis carinii pneumonia (PCP) prophylaxis is required during the concomitant administration of temozolomide and radiotherapy and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC grade less than or equal to 1).

Temozolomide dosing interruption or discontinuation during concomitant radiotherapy and temozolomide:
Absolute Neutrophil Count (ANC)
Interrupt temozolomide if greater than or equal to 0.5 and less than 1.5 x 10(9)/L
Discontinue temozolomide if less than 0.5 x 10(9)/L
Platelet Count
Interrupt temozolomide if greater than or equal to 10 and less than 100 x 10(9)/L
Discontinue temozolomide if less than 10 x 10(9)/L
CTC - Nonhematologic Toxicity (except for alopecia, nausea, and vomiting)
Interrupt temozolomide if CTC grade 2
Discontinue temozolomide if CTC grade 3 or 4

If treatment with concomitant temozolomide is interrupted, it may be continued when all of the following conditions are met: ANC greater than or equal to 1.5 x 10(9)/L and CTC nonhematologic toxicity less than or equal to grade 1 (except for alopecia, nausea, and vomiting)

Maintenance Phase Cycle 1:
Four weeks after completing the temozolomide and RT phase, temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.

Cycles 2 through 6:
At the start of cycle 2, the dose is escalated to 200 mg/m2, if the CTC nonhematologic toxicity for cycle 1 is less than or equal to grade 2 (except for alopecia, nausea, and vomiting), ANC is greater than or equal to 1.5 x 10(9)/L, and the platelet count is greater than or equal to 100 x 10(9)/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at cycle 2, then escalation should not be done in subsequent cycles.

Dose reduction or discontinuation during maintenance:
During treatment, a complete blood count should be obtained on day 22 (21 days after the first dose of temozolomide) or within 48 hours of that day, and weekly until the ANC is above 1.5 x 10(9)/L and the platelet count exceeds 100 x 10(9)/L. The next cycle of temozolomide should not be started until the ANC and platelet count exceeds these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle.

Temozolomide dose levels for maintenance treatment:
Dose level -1 is a dose of 100 mg/m2/day (reduction for prior toxicity).
Dose level 0 is a dose of 150 mg/m2/day (dose during cycle 1).
Dose level 1 is a dose of 200 mg/m2/day (dose during cycles 2 through 6 in the absence of toxicity).

Temozolomide reduction or discontinuation during maintenance treatment:
Absolute Neutrophil Count
Reduce temozolomide by one dose level if ANC is less than 1.0 x 10(9)/L.
Discontinue temozolomide if dose reduction to less than 100 mg/m2 is required or if the same grade 3 nonhematologic toxicity (except for alopecia, nausea, or vomiting) recurs after dose reduction.
Platelet Count
Reduce temozolomide by one dose level if the platelet count is less than 50 x 10(9)/L.
Discontinue temozolomide if dose reduction to less than 100 mg/m2 is required or if the same grade 3 nonhematologic toxicity (except for alopecia, nausea, or vomiting) recurs after dose reduction.
CTC - Nonhematologic Toxicity (except for alopecia, nausea, and vomiting)
Reduce temozolomide by one dose level if CTC grade 3.
Discontinue temozolomide if CTC grade 4.

What other drugs will affect temozolomide?

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

  • carbamazepine;

  • divalproex sodium;

  • phenytoin;

  • valproic acid;

  • steroids; or

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

This list is not complete and other drugs may interact with temozolomide. 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 temozolomide.
  • 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 1996-2012 Cerner Multum, Inc. Version: 9.02. Revision Date: 2013-07-09, 11:40:29 AM.

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