Oxalotin 5 mg/ml (IV Infusion)

Indications

• Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor
• Treatment of advanced colorectal cancer

Pharmacology

• Nonenzymatic conversion in physiologic solutions to active derivatives
• Formation of transient reactive species and crosslinks in DNA
• Cell-cycle nonspecific cytotoxicity
• In vivo antitumor activity against colon carcinoma
• In vitro and in vivo antiproliferative activity
• Greater antiproliferative activity in combination with 5-fluorouracil

Dosage & Administration

• Administered every 2 weeks
• Recommended treatment duration for advanced disease
• Recommended treatment duration for adjuvant use
• Specific dosage and administration instructions for each day of the treatment cycle

Interaction

• No specific cytochrome P-450-based drug interaction studies conducted
• No observed pharmacokinetic interaction at recommended dosage
• Potential impact on 5-fluorouracil plasma concentrations
• Potential decrease in clearance with coadministration of nephrotoxic compounds

Contraindications

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

Side Effects

• Most common adverse reactions
• Incidence of peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, transaminase and alkaline phosphatase increase, diarrhea, emesis, fatigue, and stomatitis
• Reported occurrence of other adverse reactions, including serious adverse reactions

Pregnancy & Lactation

• Pregnancy Category D
• Potential fetal harm
• Lack of adequate and well-controlled studies in pregnant women
• Advisement for women of childbearing potential
• Unknown excretion in human milk
• Consideration for discontinuation of nursing

Precautions & Warnings

• Observation of allergic reactions and potential fatality
• Monitoring of neurological toxicity, especially in co-administration cases
• Management of acute laryngopharyngeal dysaesthesias
• Association with pulmonary fibrosis and fatal cases
• Reactions related to liver sinusoidal obstruction syndrome and investigations needed
• Reported cardiovascular toxicity, including QT prolongation and arrhythmias
• Recommendation for ECG monitoring and electrolyte correction
• Avoidance in patients with congenital long QT syndrome

Overdose Effects

• Lack of known antidote for overdose
• Anticipated complications and observed adverse reactions in reported overdoses
• Supportive treatment recommendation

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Cool and dry place
• Protected from light and moisture
• Keep out of reach of children

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