Oxaliplatin for Injection

Oxaliplatin for Injection, used in combination with infusional 5-fluorouracil/leucovorin, 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.

Details

Introduction

A white or similar jelly loose powder

Nombre del Producto: Oxaliplatino para inyección

Specification: 50mg

Package: 50mg/vial,1vial/box

Standard: USP

Usage and Dosage

Administer Oxaliplatin for Injection in combination with 5-fluorouracil/leucovorin every 2 weeks. For advanced disease, treatment is recommended until disease progression or unacceptable toxicity. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):

Day 1: Oxaliplatin for Injection 85 mg/m² intravenous infusion in 250-500 mL 5% Dextrose injection, USP and 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.

 

Side effects

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Anaphylaxis and Allergic reactions

Neuropathy

Severe Neutropenia 

Pulmonary Toxicities 

Hepatotoxicity

Cardiovascular Toxicities 

Rhabdomyolysis.

 

Drug Interactions

No specific cytochrome P-450-based drug interaction studies have been conducted. No pharmacokinetic interaction between 85 mg/m² Oxaliplatin for Injection 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 for Injection dosed every 3 weeks.

 

Contraindications

Oxaliplatin for Injection should not be administered to patients with a history of known allergy to ELOXATIN or other platinum compounds.

 

Precautions

ANAPHYLACTIC REACTIONS

Anaphylactic reactions to Oxaliplatin for Injection have been reported, and may occur within minutes of Oxaliplatin for Injection administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms of anaphylaxis

 

Clinical Pharmacology

Mechanism Of Action

Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand. Several transient reactive species are formed, including monoaquo and diaquo DACH platinum, which covalently bind with macromolecules. Both inter-and intrastrand Pt-DNA crosslinks are formed. Crosslinks are formed between the N7 positions of two adjacent guanines (GG), adjacent adenine-guanines (AG), and guanines separated by an intervening nucleotide (GNG). These crosslinks inhibit DNA replication and transcription. Cytotoxicity is cell-cycle nonspecific.

In vivo studies have shown antitumor activity of oxaliplatin against colon carcinoma. In combination with 5-fluorouracil, oxaliplatin exhibits in vitro andin vivo antiproliferative activity greater than either compound alone in several tumor models [HT29 (colon), GR (mammary), and L1210 (leukemia)]


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