Aiheng Oxaliplatin for Injection

1. Indications and Usage
Metastatic Colorectal Cancer: Treatment of metastatic colorectal cancer in combination with 5-fluorouracil and leucovorin as first-line therapy.
Adjuvant Treatment: Treatment of patients with locally advanced colon cancer following complete tumor resection, in combination with 5-fluorouracil and leucovorin.
2. Dosage and Administration
Standard Regimen: The recommended dose is 130 mg/m² administered intravenously over 2 to 6 hours every 3 weeks, or 85 mg/m² every 2 weeks.
Administration: Dilute in 250-500 mL of 5% Glucose Injection. Do not mix with or administer simultaneously through the same infusion line with sodium chloride or alkaline solutions.
Dose Modifications: Reduce dose or interrupt therapy based on neurologic toxicity and other adverse reactions.
3. Mechanism of Action
DNA Cross-linking: Oxaliplatin forms 1,2-diaminocyclohexane (DAC) platinum complexes that bind to DNA.
Inhibition of Replication: These complexes form intrastrand and interstrand DNA cross-links, which inhibit DNA synthesis and trigger apoptotic cell death.
4. Safety and Warnings
Neurotoxicity: Peripheral sensory neuropathy is a dose-limiting toxicity. Acute cold-induced neuropathy may occur with exposure to cold temperatures during or shortly after infusion.
Hepatotoxicity: Venous occlusive liver disease (also known as sinusoidal obstruction syndrome) has been reported.
Hypersensitivity Reactions: Severe hypersensitivity reactions, including anaphylaxis, may occur.
Bone Marrow Suppression: Neutropenia and thrombocytopenia may occur, particularly when combined with 5-fluorouracil.
5. Adverse Reactions and Clinical Research
Common: Peripheral neuropathy, nausea, vomiting, diarrhea, neutropenia, and thrombocytopenia.
Clinical Research: Clinical trials have demonstrated significant improvements in disease-free survival and overall survival in both the adjuvant and metastatic settings.
6. Drug Interactions
Alkaline Solutions and 5-FU: Contraindicated due to precipitation.
Nephrotoxic Drugs: Concomitant use may increase renal toxicity.
Live Vaccines: Concomitant use is contraindicated due to the immunosuppressive effects of chemotherapy.
7. Pharmaceutical Information
Active Ingredient: Oxaliplatin.
Appearance: Clear, colorless or almost colorless liquid.
Storage: Store at 25°C; protect from light.