Innovative DepoFoam Technology Delivers Bupivacaine Over Time
Pacira Pharmaceuticals, Inc., makers of EXPAREL®, own the proven product delivery technology, DepoFoam. DepoFoam has been used safely in two other products, and has a demonstrated safety record and history of regulatory approvals in the United States, Europe, and several other countries around the world.
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- EXPAREL uses DepoFoam, a multivesicular liposomal drug delivery technology, to encapsulate bupivacaine
- Following injection, bupivacaine is released over time as the DepoFoam lipid membranes erode and reorganize
- In EXPAREL, DepoFoam is <3% lipid, biodegradable, and biocompatible
How it Works
The DepoFoam carrier matrix is made up of microscopic, polyhedral particles composed of numerous, non-concentric, internal aqueous chambers that encapsulate drugs without altering their molecular structure and then release them over a desired period of time. Each chamber is separated from adjacent chambers by lipid membranes. Following injection, the DepoFoam particles release medication over time due to erosion and/or reorganization of the lipid membranes.
DepoFoam-based drugs are formulated as ready-to-use, aqueous suspensions allowing for simple injection through needles with a bore size as narrow as 25 gauge.
These are not all of the potential important safety considerations for EXPAREL, please see the full Prescribing Information.
- Pacira Pharmaceuticals, Inc. www.pacira.com. Accessed November 4, 2011.
Important Safety Information
EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.
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. Other formulations of bupivacaine 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.
Studies demonstrating the safety and efficacy of EXPAREL were conducted in hemorrhoidectomy and bunionectomy; EXPAREL has not been demonstrated to be safe and effective in other procedures.
Please see the full Prescribing Information for EXPAREL.