ts treated with Gemzar who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and if non–hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of Gemzar at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and that non–hematologic toxicity has not been greater than WHO Grade 1.
Combination Use:
Non–Small Cell Lung Cancer— Two schedules have been investigated and the optimum schedule has not been determined (see CLINICAL STUDIES). With the 4–week schedule, Gemzar should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28–day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemzar. With the 3–week schedule, Gemzar should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21–day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemzar on Day 1. See prescribing information for cisplatin administration and hydration guidelines.
Dose Modifications— Dosage adjustments for hematologic toxicity may be required for Gemzar and for cisplatin. Gemzar dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Gemzar should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 13. For cisplatin dosage adjustment, see manufacturer’s prescribing information.
In general, for severe (Grade 3 or 4) non–hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemzar plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for Gemzar plus cisplatin was 5% versus 2% for cisplatin alone).
Breast Cancer — Gemzar should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21–day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3–hour intravenous infusion before Gemzar administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.
Dose Modifications — Gemzar dosage adjustments for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemzar dosage should be modified according to the guidelines in Table 14.
Table 14: Day 8 Dosage Reduction Guidelines for Gemzar in Combination with Paclitaxel Absolute granulocyte count
(x 106/L)
Platelet count
(x 106/L)
% of full dose
≥1200
and
>75,000
