Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS Specific for EXPAREL
- Using EXPAREL followed by other bupivacaine formulations has not been studied in clinical trials. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL
*The following was added:
- …Bupivacaine HCl, when injected immediately before or admixed with EXPAREL, may impact the pharmacokinetic and/or physicochemical properties of the drugs if the milligram dose of bupivacaine HCl solution exceeds 50% of the EXPAREL dose. The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to toxicity
USE IN SPECIFIC POPULATIONS
*The following was edited:
*Edited to reflect that based on animal data, may cause fetal harm. (8.1).