and <100 × 109/L <10 × 109/L
CTC Nonhematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 2 CTC Grade 3 or 4
Maintenance Phase Treatment Schedule
Four weeks after completing the TEMODAR + RT phase, TEMODAR 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. At the start of Cycle 2, the dose is escalated to 200 mg/m2 , if the CTC nonhematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥1.5 × 109/L, and the platelet count is ≥100 × 109/L. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
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 (1,500/µL) and the platelet count exceeds 100 × 109/L (100,000/µL). The next cycle of TEMODAR should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst non-hematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 3 and 4.
TABLE 3: 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 4: Temozolomide Dose Reduction or Discontinuation During Maintenance Treatment Toxicity Reduce TMZ by 1 Dose Level* Discontinue TMZ
TMZ = temozolomide; CTC = Common Toxicity Criteria.
TMZ dose levels are listed in Table 3.
TMZ is to be discontinued if dose reduction to <100 mg/m2 is required or if the same Grade 3 nonhematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Absolute Neutrophil Count <1.0 × 109/L See footnote †
Platelet Count <50 × 109/L See footnote †
CTC Nonhematological Toxicity
(except for alopecia, nausea, vomiting) CTC Grade 3 CTC Grade 4†
How is TEMODAR taken?
Patients should take each day's dose 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 TEMODAR, they should be advised to take these medications 30 minutes before they take TEMODAR. 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 TEMODAR capsules should be swallowed whole and NEVER CHEWED.
What should the patient avoid during treatment with TEMODAR?
There are no dietary restrictions for patients taking TEMODAR. TEMODAR may affect testicular function, so male patients should exercise adequate birth control measures. TEMODAR may cause birth defects. Female patients |
