Exparel FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 13, 2023.
FDA Approved: Yes (First approved October 28, 2011)
Brand name: Exparel
Generic name: bupivacaine liposome
Dosage form: Injectable Suspension
Company: Pacira Pharmaceuticals, Inc.
Treatment for: Postoperative Pain
Exparel (bupivacaine liposome) is a long-acting amide local anesthetic used for postsurgical analgesia.
- Exparel is indicated to produce postsurgical:
- Local analgesia via infiltration in patients aged 6 years and older
- Regional analgesia via an interscalene brachial plexus nerve block in adults (for total shoulder arthroplasty or rotator cuff repair surgeries)
- Regional analgesia via a sciatic nerve block in the popliteal fossa in adults (for foot, ankle, achilles tendon, and other lower leg surgeries)
- Regional analgesia via an adductor canal block in adults (for surgery of the knee, medial lower leg, and ankle surgeries). - Exparel contains the local anesthetic bupivacaine which works to produce postsurgical analgesia by blocking the generation and the conduction of nerve impulses. Exparel uses the DepoFoam® proprietary multivesicular liposome (pMVL) technology to deliver bupivacaine for an extended period of time, providing analgesia for up to 72 hours after a single dose.
- Exparel is administered by injection for local analgesia via infiltration, and regional analgesia via nerve block.
- Warnings and precautions associated with Exparel include monitoring of cardiovascular status, neurological status, and vital signs during and after injection; caution in patients with hepatic disease; and methemoglobinemia. Additional use of local anesthetics should be avoided within 96 hours following administration of Exparel.
- Common adverse reactions following administration via infiltration in adults include nausea, constipation, and vomiting; and in pediatric patients six to less than 17 years of age include nausea, vomiting, constipation, hypotension, anemia, muscle twitching, blurred vision, pruritus, and tachycardia.
Common adverse reactions following administration via nerve block in adults include nausea, pyrexia, headache, and constipation.
Development timeline for Exparel
Further information
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