NEW INDICATION: EXPAREL is now approved for use in interscalene brachial plexus nerve block
EXPAREL PROVIDES 48 HOURS OF PAIN CONTROL WHILE REDUCING THE NEED FOR OPIOIDS
Significant reduction in pain at 48 hours *
EXPAREL 133 mg (10 mL) provided a 46% reduction in pain scores compared to placebo (P<0.0001)1
Significant reduction in opioid use through 48 hours
EXPAREL 133 mg (10 mL) provided a 78% reduction in the use of opioids compared to placebo (P<0.0001)2
No cumbersome pumps or catheters necessary
* Results from a phase 3, double-blind, randomized controlled trial that compared the postsurgical analgesia efficacy, safety, and pharmacokinetics of EXPAREL 133 mg (10 mL) and placebo in a total shoulder arthroplasty or rotator cuff repair. Primary and secondary endpoints: pain intensity through 48 hours postsurgery, as measured by area under the curve (AUC) of visual analog scale (VAS) pain intensity scores, and total postsurgical opioid consumption.1 were available upon patient request.
Rescue opioids for pain †The clinical benefit of the decrease in opioid consumption was not demonstrated in clinical trials.
EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.
Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via infi ltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation.
If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine.
EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients.
Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.
Warnings and Precautions Specifi c to EXPAREL
Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use.
The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.
Warnings and Precautions for Bupivacaine-Containing Products
Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.
Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias, sometimes leading to death.
Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.
Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.
Please see brief summary of Prescribing Information on adjacent page. Full Prescribing Information is available at www.EXPAREL.com
References: 1. Patel M, Gadsden J, Bao X, Bendtsen T. Brachial plexus block with liposomal bupivacaine for total shoulder arthroplasty or rotator cuff repair: results from a randomized controlled trial. Poster presented at: The New York School of Regional Anesthesia 16th Annual Fall Symposium; September 23–24, 2017; New York, NY. 2. Data on file. 4513. Parsippany, NJ: Pacira Pharmaceuticals, Inc.; March 2018.
For more information, please visit www.EXPAREL.com
or call 1-855-RX-EXPAREL (793-9727).
©2018 Pacira Pharmaceuticals, Inc. Parsippany, NJ 07054 PP-EX-US-3572 04/18
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