Important new information about EXPAREL®
The FDA confirms that EXPAREL has always been approved for "administration into the surgical site to produce postsurgical analgesia" for use in a variety of surgeries not limited to those studied in its pivotal trials.
"We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate."
- Dave Stack, Chief Executive Officer and Chairman of Pacira
The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
Important Safety Information
- EXPAREL is contraindicated in obstetrical paracervical block anesthesia
- EXPAREL has not been studied for use in patients younger than 18 years of age
- Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL
- Monitoring of cardiovascular and neurological status as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products
- Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations
- In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting