Temozolomide Dosage

This dosage information may not include all the information needed to use Temozolomide safely and effectively. See additional information for Temozolomide.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage 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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dosage of temozolomide must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and neutrophil and platelet counts at the time of initiating the next cycle.

Precautions

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Temozolomide therapy can be continued until disease progression.

To reduce nausea and vomiting, temozolomide should be taken on an empty stomach. Bedtime administration may be advised. Antiemetic therapy may be administered to and/or following administration of temozolomide.

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