Becker's Hospital Review

For more information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727). CHANGE THE FACE OF POSTSURGICAL RECOVERY Choose long-lasting pain control that can reduce or eliminate the need for opioids New data: EXPAREL vs bupivacaine HCl* 1 ©2017 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054 PP-EX-US-2768 09/17 * Results from a Phase 4, double-blind, randomized controlled trial that compared the efficacy and safety of EXPAREL 266 mg (20 mL) (n=70) and bupivacaine HCl (n=69) in a total knee arthroplasty. Primary endpoints: area under the curve of visual analog scale pain intensity scores 12–48 hours postsurgery; total opioid consumption 0–48 hours postsurgery. Rescue opioids for pain were available upon patient request. Rates and types of adverse events were similar between treatment groups. The most common adverse events in the EXPAREL group were nausea, muscle spasms, and vomiting. The clinical benefit of the decrease in opioid consumption has not been demonstrated. EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia. Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. 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. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Warnings and Precautions Specific to EXPAREL EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use. 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. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL. 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 paresthesias. 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 also available at www.EXPAREL.com. Reference: 1. Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local infiltration analgesia with liposomal bupivacaine improves pain scores and reduces opioid use after total knee arthroplasty: results of a randomized controlled trial [published online ahead of print]. J Arthroplasty. doi:10.1016/j.arth.2017.07.024. 78% FEWER OPIOIDS overall opioid consumption (P<0.005) 13.6% LESS PAIN cumulative pain scores (P<0.04) 10% OF PATIENTS WERE OPIOID FREE WITH EXPAREL VS 0% WITH BUPIVACAINE HCI (P<0.01) WITH NON-OPIOID EXPAREL

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