Oxaliplatin (2 brand names, 1 dosage form, 2 routes)
Available dosage forms: INJECTABLE.
Routes of administration: INTRAVENOUS, INJECTION.
Brand Names
- ELOXATIN
- OXALIPLATIN
Boxed Warning
Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with oxaliplatin injection within minutes of administration and during any cycle. Oxaliplatin injection is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs [see Contraindications (4)]. Immediately and permanently discontinue oxaliplatin injection for hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1)].
Indications and Usage
Oxaliplatin injection USP, in combination with infusional fluorouracil and 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.
Contraindications
Oxaliplatin injection is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Peripheral Sensory Neuropathy [see Warnings and Precautions (5.2)] Severe Myelosuppression [see Warnings and Precautions (5.3)] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.4)] Pulmonary Toxicity [see Warnings and Precautions (5.5)] Hepatotoxicity [see Warnings and Precautions (5.6)] QT Interval Prolongation and Ventricular Arrhythmias [see Warnings and Precautions (5.7)] Rhabdomyolysis [see Warnings and Precautions (5.8)] Hemorrhage [see Warnings and Precautions (5.9)]
Overdosage
The maximum dose of oxaliplatin that has been administered in a single infusion is 825 mg. Several cases of overdoses have been reported with oxaliplatin injection. Adverse reactions observed following an overdosage were grade 4 thrombocytopenia (less than 25,000/mm 3) without bleeding, anemia, sensory neuropathy (including paresthesia, dysesthesia, laryngospasm and facial muscle spasms), gastrointestinal disorders (including nausea, vomiting, stomatitis, flatulence, abdomen enlarged and grade 4 intestinal obstruction), grade 4 dehydration, dyspnea, wheezing, chest pain, respiratory failure, severe bradycardia, and death. Closely monitor patients suspected of receiving an overdose, including for the adverse reactions described above and administer appropriate supportive treatment.