Oxaliplatin for injection is an anti-cancer (chemotherapy) medicine used in combination with infusional 5-fluorouracil/leucovorin (5-FU/LV). The medical uses of oxaliplatin are as follows:
● Oxaliplatin is used as an adjuvant treatment of patients with stage-III (Dukes' C) colon cancer after complete resection of primary tumor.
● Oxaliplatin is used for the treatment of patients with metastatic colorectal cancer.
Dosage: Administer Oxaliplatin in combination with 5-fluorouracil/leucovorin every 2 weeks. For advanced disease, the therapy is recommended until the disease is progressive or unacceptable toxicity occurs. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):
Day 1: Oxaliplatin 85 mg/m² intravenous infusion in 250 to 500 mL 5 percent Dextrose injection, USP and leucovorin 200 mg/m² intravenous infusion in 5 percent Dextrose Injection, USP both administered over 120 minutes persistently in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m² intravenous bolus administered over 2 to 4 minutes, followed by 5-fluorouracil 600 mg/m² intravenous infusion in 500 mL 5 percent Dextrose Injection, USP (recommended) as a 22 hour continuous infusion.
Day 2: Leucovorin 200 mg/m² is administered by intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m² intravenous bolus administered over 2 to 4 minutes, followed by 5-fluorouracil 600 mg/m² intravenous infusion in 500 mL 5 percent Dextrose Injection, USP (recommended) as a 22 hour continuous infusion.
The administration of Oxaliplatin does not need prehydration. The premedication with antiemetics, including 5-HT3 blockers either with or without dexamethasone, is recommended.
Dose Modification Recommendations: Before the subsequent therapy cycles, patients should be assessed for clinical toxicities and recommended laboratory tests. Prolongation of infusion time for Oxaliplatin from two hours to six hours may mitigate acute toxicities. The infusion times for 5-FU/LV are not required to be changed.
Preparation Of Infusion Solution: Avoid freezing and protect it from light concentrated solution. The final dilution should never be performed with a sodium chloride solution or other chloride-containing solutions. Solution must be further diluted in an infusion solution of 250 to 500 mL of five percent Dextrose Injection, USP. Following dilution with 250 to 500 mL of five percent Dextrose Injection, USP, the shelf life is 6 hours at room temperature [20°C to 25°C (68°F to 77°F)] or up to 24 hours under refrigeration [2°C to 8°C (36°F to 46°F)]. Following the final dilution, protection from the light is not needed.
Oxaliplatin is incompatible in solution with alkaline medicines or media (such as basic solutions of 5-fluorouracil) and never be mixed with these or used simultaneously through the same infusion line. The infusion line should be flushed with five percent Dextrose Injection, USP before administration of any concomitant medicine.
Dosage Forms & Strengths: The oxaliplatin a cancer medication basically is supplied in the single-use vials containing 100 mg or 50 mg of active pharmaceutical ingredient (oxaliplatin) as a sterile, preservative-free, aqueous solution at the concentration of 5 mg/mL.
Storage And Handling: Oxaliplatin is supplied in clear, glass, single-use vials with the gray elastomeric stoppers and aluminum flip-off seals containing 100 mg or 50 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at the concentration of 5 mg/mL. Water for Injection, USP, exists as an inactive ingredient.
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