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Temozolomide Dosage

Medically reviewed on November 8, 2017.

Applies to the following strengths: 5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg

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

Renal Dose Adjustments

Dose adjustment(s) may be required in patients; however, no specific guidelines have been suggested. Caution is recommended.

Liver Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution is recommended.

Dose Adjustments

Glioblastoma Multiforme:
Concomitant Phase:
Interruption of Therapy:
-Absolute Neutrophil Count (ANC) greater than or equal to 0.5 and less than 1.5 x 10(9)/L
-Platelet count greater than or equal to 10 and less than 100 x 10(9)/L
-Common Toxicity Criteria (CTC) Nonhematological Toxicity (except for alopecia, nausea, vomiting) grade 2

Discontinuation of Therapy:
-ANC less than 0.5 x 10(9)/L
-Platelet count less than 10 x 10(9)/L
-CTC Nonhematological Toxicity grade 3 or 4

Maintenance Phase:
Reduce Dose by 1 Dose Level:
-Dose should be reduced to 100 mg/m2 for prior toxicity
-ANC less than 1.0 x 10(9)/L
-Platelet count less than 50 x 10(9)/L
-CTC Nonhematological Toxicity grade 3

Discontinuation of Therapy:
-If dose reduction to less than 100 mg/m2 is required.
-If the same Grade 3 CTC nonhematological toxicity recurs after dose reduction.
-CTC Nonhematological Toxicity grade 4

Anaplastic Astrocytoma:
Dose Reduction:
-If the ANC falls below 1.0 x 10(9)/L or the platelet count is less than 50 x 10(9)/L during any cycle, the next cycle should be reduced by 50 mg/m2 but not below 100 mg/m2.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Oral Capsules:
-Swallow capsules whole with a glass of water.
-Consistency of administration with respect to food is recommended.
-To reduce nausea and vomiting, take this drug on an empty stomach.
-If vomiting occurs after administration, a second dose should not be administered that day.
-Bedtime administration may be advised.

IV Injection:
-Withdraw volume necessary for dose and transfer into an empty 250 mL infusion bag.
-Infuse IV over 90 minute using pump.
-Flush lines before and after each infusion. Infuse only via IV.
-May be administered in the same IV line with 0.9% Sodium Chloride injection only.

Storage requirements:
IV Injection:
-Prior to reconstitution, store in refrigerator.
-After reconstitution, store product at room temperature. Reconstituted product must be used within 14 hours including infusion time.

Reconstitution/preparation techniques:
IV Injection:
-Bring vial to room temperature prior to reconstitution.
-Reconstitute with 41 mL of Sterile Water for Injection and gently swirl vial. Do not shake.
-Inspect vial for visible particular matter. If particulates are present, do not use.
-Do not further dilute reconstituted product.

Patient advice:
-Antiemetic therapy may be administered prior to and/or following administration.
-If capsules are open or damaged, precautions should be taken to avoid inhalation or contact with the skin or mucous membranes.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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