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FDA Approves Expanded Use of Exparel Nerve Block

Pacira news release; 2018 Apr 6

Pacira Pharmaceuticals, Inc. has announced that the US Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to broaden the use of Exparel (bupivacaine liposome injectable suspension) to include administration via interscalene brachial plexus block to produce postsurgical regional analgesia. With this approval, Exparel is the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.

Dosage/administration: Exparel is intended for single-dose administration only. Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same. It is not possible to convert dosing from other formulations of bupivacaine to Exparel. Exparel should not be diluted with water for injection or other hypotonic solution. The recommended dose of Exparel for local infiltration in adults is up to a maximum dose of 266 mg (20 mL). The recommended dose of Exparel for interscalene brachial plexus nerve block in adults is 133 mg (10 mL).

Adverse reactions: Adverse reactions reported with an incidence ≥10% following Exparel administration via infiltration were nausea, constipation, and vomiting. Adverse reactions reported with an incidence ≥10% following Exparel administration via nerve block were nausea, pyrexia, and constipation.

Citation:

Pacira announces FDA approval of supplemental new drug application for Exparel as a nerve block to produce regional analgesia. [news release]. Parsippany, NJ: Pacira Pharmaceuticals, Inc. April 6, 2018. http://investor.pacira.com/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=2341466. Accessed April 24, 2018.

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