In Treatment of:
OXALIPLATIN is a platinum-based drug used in combination with infusional 5-fluorouracil /leucovorin, which is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
Treatment of advanced colorectal cancer.
Most common adverse reactions (incidence ≥ 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis. Other adverse reactions, including serious adverse reactions, have been reported
Known allergy to OXALIPLATIN or other platinum compounds
Allergic Reactions: Monitor for development of rash, urticaria, erythema, pruritis, bronchospasm, and hypotension.
Neuropathy: Reduce the dose or discontinue OXALIPLATIN if necessary.
Pulmonary Toxicity: May need to discontinue OXALIPLATIN until interstitial lung disease or pulmonary fibrosis are excluded.
Hepatotoxicity: Monitor liver function tests.
Pregnancy. Fetal harm can occur when administered to a pregnant woman. Women should be apprised of the potential harm to the fetus.
No specific cytochrome P-450-based drug interaction studies have been conducted. No pharmacokinetic interaction between 85 mg/m2 OXALIPLATIN and 5-fluorouracil/leucovorin has been observed in patients treated every 2 weeks. Increases of 5-fluorouracil plasma concentrations by approximately 20% have been observed with doses of 130 mg/m2 OXALIPLATIN dosed every 3 weeks. Because platinum-containing species are eliminated primarily through the kidney, clearance of these products may be decreased by coadministration of potentially nephrotoxic compounds; although, this has not been specifically studied
Administer OXALIPLATIN in combination with 5-fluorouracil/leucovorin every 2 weeks.:
Day 1: OXALIPLATIN 85 mg/m2 intravenous infusion in 250–500 mL 5% Dextrose Injection, USPand leucovorin 200 mg/m2 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/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
Day 2: leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
Reduce the dose of OXALIPLATIN to 75 mg/m2 (adjuvant setting) or 65 mg/m2 (advanced colorectal cancer):
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 × 109/L and platelets ≥75 × 109/L.
For patients with severe renal impairment (creatinine clearance <30 mL/min), the initial recommended dose is 65 mg/m2.
Discontinue OXALIPLATIN if there are persistent Grade 3 neurosensory events.
Never reconstitute or prepare final dilution with a sodium chloride solution or other chloride-containing solutions.