Expanded Indication for Exparel
April 6, 2018 – The U.S. FDA has approved a new indication for Exparel® (bupivacaine liposome injectable suspension), manufactured by Pacira Pharmaceuticals. A local anesthetic, Exparel can be used to provide regional post-surgical anesthesia when administered as an interscalene brachial plexus block.
An interscalene brachial plexus block can be used post-operatively to provide pain relief in the collarbone region, shoulder, and arm. It is accomplished by injecting a local anesthetic that temporarily blocks the nerves. This type of block can be useful following procedures performed on the shoulder, arm, and forearm to provide an analgesic effect.
Recommended dosing under the new indication is 133mg (10mL) administered via injection into the tissue of the brachial plexus region prior to the procedure. Formulated for slow release, Exparel can work for up to 120 hours.
First approved in 1972, Exparel is also indicated to provide postsurgical local analgesia in adults through single-dose infiltration. It is not considered interchangeable with other forms of local anesthetic.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.