Temozolomide

TEMOZOLOMIDE- temozolomide capsule
Accord Healthcare Inc.

1 INDICATIONS AND USAGE

1.1 Newly Diagnosed Glioblastoma

Temozolomide capsule is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.

1.2 Anaplastic Astrocytoma

Temozolomide capsule is indicated for the:

  • adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma;
  • treatment of adults with refractory anaplastic astrocytoma

2 DOSAGE AND ADMINISTRATION

2.1 Monitoring to Inform Dosage and Administration

Prior to dosing, withhold temozolomide capsules until patients have an absolute neutrophil count (ANC) of 1.5 x 10 9 /L or greater and a platelet count of 100 x 10 9 /L or greater.

For concomitant radiotherapy, obtain a complete blood count prior to initiation of treatment and weekly during treatment. For the 28-day treatment cycles, obtain a complete blood count prior to treatment on Day 1 and on Day 22 of each cycle. Perform complete blood counts weekly until recovery if the ANC falls below 1.5 x 10 9 /L and the platelet count falls below 100 x 10 9 /L.

For concomitant use with focal radiotherapy, obtain a complete blood count weekly and as clinically indicated.

2.2 Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma

Administer temozolomide capsules either orally or intravenously once daily for 42 to 49 consecutive days during the concomitant use phase with focal radiotherapy, and then once daily on Days 1 to 5 of each 28-day cycle for 6 cycles during the maintenance use phase. Provide Pneumocystis pneumonia (PCP) prophylaxis during the concomitant use phase and continue in patients who develop lymphopenia until resolution to Grade 1 or less [see Warnings and Precautions (5.3)] .

Concomitant Use Phase:

The recommended dosage of temozolomide capsule is 75 mg/m 2 orally once daily for 42 to 49 days in combination with focal radiotherapy. Focal radiotherapy includes the tumor bed or resection site with a 2 to 3 cm margin.

Other administration schedules have been used.

Obtain a complete blood count weekly. The recommended dosage modifications due to adverse reactions during concomitant use phase are provided in Table 1.

TABLE 1:Dosage Modifications Due to Adverse Reactions During Concomitant Use Phase
Adverse Reaction Interruption Discontinuation
Absolute Neutrophil Count

Withhold temozolomide if ANC is greater than or equal to 0.5 x 10 9 /L and less than 1.5 x 10 9 /L.

Resume temozolomide at the same dose when ANC is greater than or equal to 1.5 x 10 9 /L.

Discontinue temozolomide if ANC count is less than 0.5 x 10 9 /L.
Platelet Count

Withhold temozolomide if platelet count is greater than or equal to 10 x 10 9 /L and less than 100 x 10 9 /L.

Resume temozolomide at the same dose when platelet count is greater than or equal to 100 x 10 9 /L.

Discontinue temozolomide if platelet count is less than 10 x 10 9 /L.
Non-hematological Adverse Reaction (except for alopecia, nausea, vomiting)

Withhold temozolomide if Grade 2 adverse reaction occurs.

Resume temozolomide at the same dose when resolution to Grade 1 or less.

Discontinue temozolomide if Grade 3 or 4 adverse reaction occurs.

Single Agent Maintenance Use Phase:

Beginning 4 weeks after concomitant use phase completion, administer temozolomide capsules orally once daily on Days 1 to 5 of each 28-day cycle for 6 cycles. The recommended dosage of temozolomide capsules in the maintenance use phase is:

  • Cycle 1: 150 mg/m 2 per day on days 1 to 5.
  • Cycles 2 to 6: May increase to 200 mg/m 2 per day on days 1 to 5 before starting Cycle 2 if no dosage interruptions or discontinuations are required ( Table 1). If the dose is not escalated at the onset of Cycle 2, do not increase the dose for Cycles 3 to 6.

Obtain a complete blood count on Day 22 and then weekly until the ANC is above 1.5 x 10 9 /L and the platelet count is above 100 x 10 9 /L. Do not start the next cycle until the ANC and platelet count exceed these levels.

The recommended dosage modifications due to adverse reactions during the maintenance use phase are provided in Table 2.

If temozolomide is withheld, reduce the dose for the next cycle by 50 mg/m 2 per day. Permanently discontinue temozolomide in patients who are unable to tolerate a dose of 100 mg/m 2 per day.

TABLE 2: Dosage Modifications Due to Adverse Reactions During Maintenance and Adjuvant Treatment
Adverse Reactions Interruption and Dose Reduction Discontinuation

Absolute Neutrophil Count

Withhold temozolomide if ANC less than 1 x 10 9 /L. When ANC is above 1.5 x 10 9 /L, resume temozolomide at reduced dose for the next cycle.

Discontinue temozolomide if unable to tolerate a dose of 100 mg/m 2 per day.

Platelet Count

Withhold temozolomide if platelet less than 50 x 10 9 /L.

When platelet count is above 100 x 10 9 /L, resume temozolomide at reduced dose for the next cycle.

Discontinue temozolomide if unable to tolerate a dose of 100 mg/m 2 per day.

Nonhematological Adverse Reaction (except for alopecia, nausea, vomiting)

Withhold temozolomide if Grade 3 adverse reaction occurs. When resolved to Grade 1 or less, resume temozolomide at reduced dose for the next cycle.

Discontinue temozolomide if recurrent Grade 3 adverse reaction occurs after dose reduction, if Grade 4 adverse reaction occurs, or if unable to tolerate a dose of 100mg/m 2 per day.

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