Oxaliplatin PhaRes 5 mg/ml (IV Infusion)

Title

• Oxaliplatin PhaRes PhaRes

Categories

• Chemotherapy
• Oncology
• Cancer Treatment

Description

• Used for adjuvant treatment of stage III colon cancer and treatment of advanced colorectal cancer
• Undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand
• Forms both inter-and intrastrand Pt-DNA crosslinks, inhibiting DNA replication and transcription
• Exhibits in vitro and in vivo antiproliferative activity in several tumor models
• Administered in combination with 5-fluorouracil/folinic acid every 2 weeks for advanced disease
• Administered for a total of 6 months (12 cycles) for adjuvant use
• No specific cytochrome P-450-based drug interaction studies conducted
• Clearance of platinum-containing species may be decreased by coadministration of potentially nephrotoxic compounds
• Contraindicated in patients with known allergy to oxaliplatin or other platinum compounds
• Most common adverse reactions include peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis
• Pregnancy Category D with potential fetal harm, and unknown excretion in human milk
• Hypersensitivity reactions, neurological toxicity, pulmonary toxicity, hepatotoxicity, and cardiovascular toxicity should be carefully monitored
• No known antidote for oxaliplatin overdose, with anticipated complications including hypersensitivity reaction, myelosuppression, nausea, vomiting, diarrhea, and neurotoxicity
• Therapeutic Class: Cytotoxic Chemotherapy
• Store in a cool & dry place, protected from light and moisture

Dosage & Administration

• Administered in combination with 5-fluorouracil/folinic acid every 2 weeks for advanced disease
• Administered for a total of 6 months (12 cycles) for adjuvant use
• Day 1: Oxaliplatin 85 mg/m² intravenous infusion, folinic acid 200 mg/m² intravenous infusion, and 5-fluorouracil intravenous bolus and infusion
• Day 2: Folinic acid 200 mg/m² intravenous infusion, and 5-fluorouracil intravenous bolus and infusion

Pharmacology

• Undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand
• Forms both inter-and intrastrand Pt-DNA crosslinks, inhibiting DNA replication and transcription
• Exhibits in vitro and in vivo antiproliferative activity in several tumor models

Interaction

• No specific cytochrome P-450-based drug interaction studies conducted
• Clearance of platinum-containing species may be decreased by coadministration of potentially nephrotoxic compounds

Contraindications

• Contraindicated in patients with known allergy to oxaliplatin or other platinum compounds

Side Effects

• Peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue, and stomatitis

Pregnancy & Lactation

• Pregnancy Category D with potential fetal harm
• Unknown excretion in human milk

Precautions & Warnings

• Grade 3/4 hypersensitivity reactions observed in 2-3% of colon cancer patients
• Neurological, pulmonary, hepatotoxic, and cardiovascular toxicities should be carefully monitored

Overdose Effects

• No known antidote for oxaliplatin overdose
• Complications may include hypersensitivity reaction, myelosuppression, nausea, vomiting, diarrhea, and neurotoxicity

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Store in a cool & dry place, protected from light and moisture

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