Oxaliplatin injection for intravenous use

————————————— DOSAGE AND ADMINISTRATION ————————————— • Administer oxaliplatin in combination with 5-fluorouracil/leucovorin every 2 weeks. (2.1): – Day 1: Oxaliplatin 85 mg/m intravenous infusion in 250–500 mL 5% Dextrose Injection, USP and leucovorin 200 mg/m intravenous infusion in 5% Dextrose Injection, USP both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion. – Day 2: leucovorin 200 mg/m intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion. • Reduce the dose of oxaliplatin to 75 mg/m (adjuvant setting) or 65 mg/m (advanced colorectal cancer) (2.2): – if there are persistent grade 2 neurosensory events that do not resolve. – after recovery from grade 3/4 gastrointestinal toxicities (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. Delay next dose until neutrophils ≥1.5 × 10/L and platelets ≥75 × 10/L. • For patients with severe renal impairment (creatinine clearance <30 mL/min), the initial recommended dose is 65 mg/m. (2.2) • Discontinue oxaliplatin if there are persistent Grade 3 neurosensory events. (2.2) • Never prepare a final dilution with a sodium chloride solution or other chloride-containing solutions. (2.3)