Temozolomide Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Anaplastic Astrocytoma

Oral:
Initial Dose: 150 mg/m2 by mouth once daily
Maintenance Dose: 200 mg/m2 by mouth once daily

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

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

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 by mouth once daily

Duration of therapy: 42 days

IV:
75 mg/m2 IV over 90 minutes once daily

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 by mouth once daily

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

IV:
150 mg/m2 IV over 90 minutes once daily

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

Cycles 2-6:

Oral:
200 mg/m2 by mouth once daily

Duration of therapy: First 5 days of each cycle

IV:
200 mg/m2 IV over 90 minutes once daily

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.

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.

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