Becker's Hospital Review

©2016 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054 PP-EX-US-1741 07/16 Indication: EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia Duration: EXPAREL provides long-lasting pain control with less need for opioids Opioid Reduction: More patients were opioid-free versus placebo in a soft tissue trial; 28% vs 10%, respectively (P<0.0008) Admixing: Bupivacaine HCI may be administered with EXPAREL in the same syringe as long as the milligram dose ratio of bupivacaine HCI to EXPAREL does not exceed 1:2 LABEL UPDATES PROVIDE GREATER… FDA REAFFIRMS BROAD LABEL The clinical bene t of the decrease in opioid consumption was not demonstrated in pivotal trials. Reference: 1. Woodcock J. Director, Center for Drug Evaluation and Research; Food and Drug Administration. Letter to: Pacira Pharmaceuticals, Inc.; Parsippany, NJ; December 14, 2015. http://media.corporate-ir.net media_ les/IROL/22/220759/The_Warning_Letter_Withdrawal_Letter.pdf. Indication: EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia LABEL UPDATES PROVIDE GREATER… FDA REAFFIRMS BROAD LABEL "The use, efficacy, and safety of EXPAREL is not limited to any specific surgery type or site." 1 —Janet Woodcock, MD, Director, FDA ©2016 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054 PP-EX-US-1741 07/16 Indication: EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia Duration: EXPAREL provides long-lasting pain control with less need for opioids Opioid Reduction: More patients were opioid-free versus placebo in a soft tissue trial; 28% vs 10%, respectively (P<0.0008) Admixing: Bupivacaine HCI may be administered with EXPAREL in the same syringe as long as the milligram dose ratio of bupivacaine HCI to EXPAREL does not exceed 1:2 LABEL UPDATES PROVIDE GREATER… FDA REAFFIRMS BROAD LABEL Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for us 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. Formulations of bupivacaine other than EXPAREL 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. Please see brief summary of Prescribing Information on reverse side. For more information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727). The clinical bene t of the decrease in opioid consumption was not demonstrated in pivotal trials. Reference: 1. Woodcock J. Director, Center for Drug Evaluation and Research; Food and Drug Administration. Letter to: Pacira Pharmaceuticals, Inc.; Parsippany, NJ; December 14, 2015. http://media.corporate-ir.net media_ les/IROL/22/220759/The_Warning_Letter_Withdrawal_Letter.pdf.

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