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 usually given after other cancer medicines have been tried without success.

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

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Slideshow: Flashback: FDA Drug Approvals 2013

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

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

To make sure temozolomide is safe for you, tell your doctor if you have:

  • liver disease; or

  • kidney disease.

Using temozolomide may increase your risk of developing certain types of bone marrow cancer. Ask your doctor about your specific risk.

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.

Use birth control to prevent pregnancy while you are receiving temozolomide, whether you are a man or a woman. Temozolomide use by either parent may cause birth defects.

It is not known whether temozolomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take temozolomide?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Temozolomide is given in a 28-day treatment cycle, and you may only need to take the medicine during the first few days of each cycle.

If you are also receiving radiation treatment, you may need to take temozolomide for 6 to 7 weeks in a row during your first treatment cycle. Then you may be switched to a 28-day maintenance treatment cycle.

Your doctor will determine how long to treat you with temozolomide. Follow your doctor's dosing instructions very 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 sometimes be different from earlier treatment cycles. Be sure you know the correct number of capsules to take and on which days to take them. Ask your doctor or pharmacist if you have any questions.

Take all of your capsules for the day (one entire daily dose) at the same time on each dosing day of a treatment cycle. Swallow the capsules whole with a full glass of water.

Take this medicine at the same time each day.

You may need to take temozolomide at bedtime or on an empty stomach if the medicine upsets your stomach.

If you vomit shortly after taking the medicine, do not take another capsule until your next regularly scheduled dose.

Do not open the temozolomide capsule. Do not use a broken pill. The medicine from an open or broken capsule can be dangerous if it gets in your mouth or nose, or on your skin. If this occurs, rinse thoroughly with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

You may be given medication to prevent nausea or other side effects while you are receiving temozolomide.

Temozolomide can lower blood cells that help your body fight infections and help your blood to clot. 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.

Tell your doctor if you have any changes in height or weight. Temozolomide doses are based on body surface area (height and weight), and any changes may affect your dose.

Your doctor will need to check your progress while you are using temozolomide.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of temozolomide.

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 a life-threatening overdose.

Overdose can cause severe forms of some of the side effects listed in this medication guide.

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:

  • seizure (convulsions);

  • fever, chills, dry cough, feeling short of breath;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or

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

Common side effects may include:

  • bruising, skin rash;

  • loss of movement on one side of the body;

  • nausea, vomiting, loss of appetite;

  • diarrhea, constipation;

  • headache, tired feeling, memory problems;

  • dizziness, weakness, loss of coordination;

  • sleep problems (insomnia);

  • low white blood cell counts (fever, flu symptoms); or

  • hair loss.

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:

Oral:
Initial Dose: 150 mg/m2 orally once a day
Maintenance Dose: 200 mg/m2 orally once a day

Duration of Therapy: 5 consecutive days per 28-day treatment cycle

IV:
Initial Dose: 150 mg/m2 IV over 90 minutes once a day
Maintenance Dose: 200 mg/m2 IV over 90 minutes once a day

Duration of Therapy: 5 consecutive days per 28-day treatment cycle

Comments:
-Dose should only be increased to 200 mg/m2 if both the nadir and day of dosing (Day 29, Day 1 of next cycle), the ANC is greater than or equal to 1.5 x 10(9)/L and platelet count is greater than or equal to 100 x 10(9)/L.
-A complete blood count should be obtained on day 22 or within 48 hours of that day of each cycle and weekly until the ANC is above 1.5 x 10(9)/L and the platelet count is above 100 x 10(9)/L.
-The next cycle should not be started until the ANC and platelet count exceed the above levels.
-In clinical trial, treatment could be continued for a maximum of 2 years. Optimum duration of therapy is not known.
-Treatment with this drug may be continued until disease progression.

Use:
-Refractory anaplastic astrocytoma with disease progression on a drug regimen containing nitrosourea and procarbazine.

Usual Adult Dose for Glioblastoma Multiforme:

Concomitant phase with focal radiotherapy:

Oral:
75 mg/m2 orally once a day

Duration of therapy: 42 days

IV:
75 mg/m2 IV over 90 minutes once a day

Duration of therapy: 42 days

Comments:
-No dose reductions are recommended during the concomitant phase.
-Dose interruptions or discontinuation may occur based on toxicity.
-Therapy should continue throughout the 42-day concomitant phase up to 49 days if all of the following conditions are met: ANC greater than or equal to 1.5 x 10(9)/L, platelet count greater than 100 x 10(9)/L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1.
-A complete blood count should be obtained weekly during treatment.
-Pneumocystis pneumonia prophylaxis is required during the concomitant administration of this drug and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery.

Monotherapy Phase:
Cycle 1:

Oral:
150 mg/m2 orally once a day

Duration of therapy: 5 days followed by 23 days without treatment

IV:
150 mg/m2 IV over 90 minutes once a day

Duration of therapy: 5 days followed by 23 days without treatment

Cycles 2-6:

Oral:
200 mg/m2 by mouth once a day

Duration of therapy: First 5 days of each cycle

IV:
200 mg/m2 IV over 90 minutes once a day

Duration of therapy: First 5 days of each cycle

Comments:
-At the start of cycle 2, the dose should be escalated to 200 mg/m2 if: CTC nonhematological toxicity for Cycle 1 is grade less than or equal to 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 for cycles 2 through 6 unless toxicity occurs.
-If the dose was not escalated at the beginning of cycle 2, escalation should not be done in subsequent cycles.
-Obtain a complete blood count on day 22 or within 48 hours of that day of each cycle and weekly until the ANC is greater than 1.5 x 10(9)/L and the platelet count is greater than 100 x 10(9)/L. The next cycle should not be started until the ANC and platelet levels exceed these numbers.
-Dose reductions should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle.

Use:
-Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

Usual Pediatric Dose for Anaplastic Astrocytoma:

Less than 3 years: Safety and efficacy have not been established

3 years or older:
Previously Untreated with Chemotherapy:

200 mg/m2 orally once a day

Duration of therapy: 5 days followed by 23 days without treatment

Previously Treated with Chemotherapy:

Initial Dose: 150 mg/m2 orally once a day

Maintenance Dose: 200 mg/m2 orally once a day

Duration of therapy: First 5 days of each treatment cycle

Comments:
-Dose in cycle 2 for patients previously treated with chemotherapy should be increased if there is no haematological toxicity.
-If the nadir on 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 platelet counts are greater than or equal to 100 × 10(9)/L, the dose may be increased to 200 mg/m2 orally once daily 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 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.
-Treatment may be continued until disease progression or a maximum of 2 years.

Use:
-Recurrent or progressive malignant glioblastoma multiforme or anaplastic astrocytoma

Usual Pediatric Dose for Glioblastoma Multiforme:

Less than 3 years: Safety and efficacy have not been established

3 years or older:
Previously Untreated with Chemotherapy:

200 mg/m2 orally once a day

Duration of therapy: 5 days followed by 23 days without treatment

Previously Treated with Chemotherapy:

Initial Dose: 150 mg/m2 orally once a day

Maintenance Dose: 200 mg/m2 orally once a day

Duration of therapy: First 5 days of each treatment cycle

Comments:
-Dose in cycle 2 for patients previously treated with chemotherapy should be increased if there is no haematological toxicity.
-If the nadir on 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 platelet counts are greater than or equal to 100 × 10(9)/L, the dose may be increased to 200 mg/m2 orally once daily 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 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.
-Treatment may be continued until disease progression or a maximum of 2 years.

Use:
-Recurrent or progressive malignant glioblastoma multiforme or anaplastic astrocytoma

What other drugs will affect temozolomide?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with temozolomide, especially:

  • steroid medicine (dexamethasone, prednisone, and others); or

  • valproic acid (Depakene, Stavzor).

This list is not complete. Other drugs may interact with temozolomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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: 11.01. Revision Date: 2014-09-02, 8:12:04 AM.

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