Renoxtin 5 mg/ml (IV Infusion)

Indications

• Adjuvant treatment of stage III colon cancer
• Treatment of advanced colorectal cancer

Pharmacology

• Formation of reactive species
• DNA replication and transcription inhibition
• Cell-cycle nonspecific cytotoxicity
• Antitumor activity against colon carcinoma

Dosage & Administration

• Administered in combination with 5-fluorouracil/folinic acid every 2 weeks
• Treatment duration for advanced disease and adjuvant use
• Specific dosage and administration instructions for different days

Interaction

• No specific cytochrome P-450-based drug interaction studies conducted
• Platinum-containing species elimination through the kidney
• Potential nephrotoxic compound coadministration

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
• Stomatitis
• Other reported adverse reactions, including serious ones

Pregnancy & Lactation

• Pregnancy Category D
• Potential fetal harm
• No adequate and well-controlled studies in pregnant women
• Advice for women of childbearing potential
• Unknown excretion in human milk
• Consideration for nursing mothers

Precautions & Warnings

• Grade 3/4 hypersensitivity
• Neurological toxicity monitoring
• Acute laryngopharyngeal dysaesthesias management
• Pulmonary toxicity association
• Hepatotoxicity and liver function test monitoring
• Cardiovascular toxicity including QT prolongation and ventricular arrhythmias
• ECG monitoring recommendations
• Avoidance in patients with congenital long QT syndrome

Overdose Effects

• No known antidote for overdose
• Complications of overdose including hypersensitivity reaction, myelosuppression, nausea, vomiting, diarrhea, and neurotoxicity
• Cases of reported overdoses
• Adverse reactions observed in overdose cases
• Maximum dose administered in a single infusion

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

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

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