Label Changes for:
Eloxatin (oxaliplatin) for intravenous use
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011
WARNINGS AND PRECAUTIONS
- Rechallenge is contraindicated in these patients
Reversible Posterior Leukoencephalopathy Syndrome
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS, also known as PRES, Posterior Reversible Encephalopathy Syndrome) has been observed in clinical trials (< 0.1%) and postmarketing experience. Signs and symptoms of RPLS could be headache, altered mental functioning, seizures, abnormal vision from blurriness to blindness, associated or not with hypertension. Diagnosis of RPLS is based upon confirmation by brain imaging.
Use in Specific Populations
Patients with Renal Impairment
- The exposure (AUC) of unbound platinum in plasma ultrafiltrate tends to increase in renally impaired patients. Caution and close monitoring should be exercised when Eloxatin is administered to patients with renal impairment. The starting Eloxatin dose does not need to be reduced in patients with mild (creatinine clearance=50-80 mL/min) or moderate (creatinine clearance=30-49 mL/min) renal impairment. However, the starting dose of Eloxatin should be reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min)