Temoloz Cap- Temozolamide Cap

Temoloz Cap- Temozolamide Cap

Temozolamide Cap

Strength: 20mg / 100mg / 250mg

Pack Size: 1 x 5

Drug Class: alkylating agents

Dosage and Administration:

Dosage of TEMOLOZ Capsules must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophill and plated counts at the time of initiating the next cylce.

Patients with newly diagnosed high grade glioma:

Concomitant Phase : TEMOLOZ is administered orally at 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions) followed by maintenance TEMOLOZ for 6 cycles. Focal RT includes the tumor bed or resection site with a 2-3 cm margin. No dose reductions are recommended during the concomitant phase; however, dose interruptions or discontinuation may occur based on toxicity. The TEMOLOZ dose should be continued throughtout the 42 day concomitant period up to 49 days if all of the following conditions are met; absolute neutrophil count> 1.5 x 102/L platelet count> 100X102/L common toxicity criteria (CTC) non-hematological toxicity<Grade 1 (except for alopecia, nausea and vomiting.)

Maintenance Phase Cycle 1: Four weeks after completing the TEMOLOZ + RT PHASE, TEMOLOZ 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 2-6 : At the start of Cycle 2, the dose is escalated to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade <2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is >1.5 x102/L, and the platelet count is >100×102/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, escalation should not be done in subsequent cycles.

Dose reduction or discontinuation during maintenance

Dose reductions during the maintenance phase should be applied according to tables 1 and 2.

Patients with refractory analplastic astrocytoma

For adults the initial dose is 150 mg/m2 orally once daily for 5 consecutive days per 28-days treatment cycle. For adult patients, if both the nadir and day of dosing (Day 29, Day 1 of next

Table 1 Temozolomide Dose Levels for Maintenance Treatment.,

Dose Level	Dose mg/m2/day	Remarks
1	100	Reduction for Prior toxicity.
0	150	Dose during Cycle 1
1	200	Dose during Cycles 2-6 in absence of toxicity.

Table 2 Temozolomide Dose Reduction or Discontinuation During Maintenance Treatment.

Toxicity	Reduce TMZ by 1 Dose Level	Discontinue TMZ
Absolute Neutrophill Count	<1.0x 109/L	See footnote b
Platelet Count	<50×109/L	See footnote b
CTC Non-hematological Toxicity (except for alopecia, nausea, vomiting)	CTC Grade 3	CTC Grade 4b.

a: TMZ dose level are listed in 6.

b: TMZ is to be discontinued if dose reduction to <100 mg/m2 is required or if the same Grade 3

non-hematological toxicity (except for alopecia, nausea, vomiting ) recurs after dose reduction.

TMZ= temozolomide; CTC = Common Toxicity Criteria.

cycle) ANC are > 1.5×109/L (1,500/uL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are> 100×109/L (1,00,000/uL), the TEMOLOZ 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 1.5×109/L (50,000/uL) during any cycle, the next cycle should be reduced by 50 mg/m2, but not below 100 mg/m2, the lowest recommended dose. TEMOLOZ therapy can be continued until disease progression. In the clinical trial, treatment could be continued for a maximum of 2 years; but the optimum duration of therapy is not known.

Handling and Disposal

TEMOLOZ causes the rapid appearance of malignant tumors in rats. Capsules should not be opened. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that allof the procedures recommended in the guidelines are necessary or appropriate.

Administration of TEMOLOZ

Patients should take each days with a full glass of water at the same time each day. Taking the medication on an empty stomach or at bedtime may help ease nausea. If patients are also taking antinausea or other medications to relieve the side effects associated with TEMOLOZ, they should be advised to take these medications 30 minutes before they take TEMOLOZ . Temozolomide causes the rapid appearance of malignant tumors in rats. Patients should not open or split the capsules. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. The medication should be kept away from children and pets. The TEMOLOZ capsules should be swallowed whole and NEVER CHEWED.

Cold Storage: no