Becker's Spine Review

DEMAND A NON-OPIOID OPTION FOR YOUR POSTSURGICAL PATIENTS EXPAREL® (bupivacaine liposome injectable suspension) provides long-lasting pain control while reducing opioid use, 4 and has been administered to over 3.5 million patients since 2012. 5 New EXPAREL data vs bupivacaine HCl demonstrate § 78% REDUCTION in overall opioid consumption (P<0.005) 13.6% REDUCTION in cumulative pain scores (P<0.04) 10% OF PATIENTS WERE OPIOID FREE WITH EXPAREL vs 0% with bupivacaine HCl (P<0.01) * According to a retrospective study of hospital discharge data (N=37,031). †According to a prospective, longitudinal study (N=109). Preoperative opioid use, self-perceived risk of addiction, and depression were each independent predictors of prolonged (6 months) opioid use after surgery. ‡ From an analysis of the 2008–2010 data in the National Survey on Drug Use and Health to examine patterns of heroin use and risk behaviors among past-year nonmedical users of opioid pain relievers. § In patients undergoing a TKA; reductions are measured through 48 hours. 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. References: 1. Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33:383-391. 2. Carroll I, Barelka P, Wang CKM, et al. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2012;115:694-702. 3. Jones CM. Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers—United States, 2002–2004 and 2008–2010. Drug Alcohol Depend. 2013;132:95-100. 4. Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJD. Local infi ltration analgesia with liposomal bupivacaine improves pain scores and reduces opioid use after total knee arthroplasty: results of a randomized controlled trial. J Arthroplasty. 2017. doi:10.1016/j.arth.2017.07.024. 5. Data on fi le. 4051. Parsippany, NJ: Pacira Pharmaceuticals, Inc.: December 2017. Indication 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 Specifi c 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 For more information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727). Please see brief summary of Prescribing Information on adjacent page. Full Prescribing Information is also available at www.EXPAREL.com. THE PRESIDENT HAS DECLARED A PUBLIC HEALTH EMERGENCY. NOW WHAT? OPIOID CRISIS IN AMERICA S P O T L I G H T O N T H E FIND OUT MORE BY VISITING EXPAREL.COM AND REQUEST TO MEET ONE OF OUR REPRESENTATIVES surgical patients prescribed an opioid may go on to long-term use or abuse 2 † 1in15 new heroin users started out by misusing opioid pain relievers 3‡ 4 of5 HOSPITAL OPERATING ROOMS ACROSS THE COUNTRY ARE FUNCTIONING AS UNINTENDED GATEWAYS TO OPIOID ADDICTION © 2 018 Pacira Pharmaceuticals, Inc., Parsippany, NJ 0 70 5 4 PP-E X-US-3 3 8 5 1/18 99 % of surgical patients receive opioids to manage postsurgical pain 1 * DEMAND A NON-OPIOID OPTION FOR YOUR POSTSURGICAL PATIENTS EXPAREL® (bupivacaine liposome injectable suspension) provides long-lasting pain control while reducing opioid use, 4 and has been administered to over 3.5 million patients since 2012. 5 New EXPAREL data vs bupivacaine HCl demonstrate § 78% REDUCTION in overall opioid consumption (P<0.005) 13.6% REDUCTION in cumulative pain scores (P<0.04) 10% OF PATIENTS WERE OPIOID FREE WITH EXPAREL vs 0% with bupivacaine HCl (P<0.01) * According to a retrospective study of hospital discharge data (N=37,031). †According to a prospective, longitudinal study (N=109). Preoperative opioid use, self-perceived risk of addiction, and depression were each independent predictors of prolonged (6 months) opioid use after surgery. ‡ From an analysis of the 2008–2010 data in the National Survey on Drug Use and Health to examine patterns of heroin use and risk behaviors among past-year nonmedical users of opioid pain relievers. § In patients undergoing a TKA; reductions are measured through 48 hours. 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. References: 1. Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33:383-391. 2. Carroll I, Barelka P, Wang CKM, et al. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2012;115:694-702. 3. Jones CM. Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers—United States, 2002–2004 and 2008–2010. Drug Alcohol Depend. 2013;132:95-100. 4. Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJD. Local infi ltration analgesia with liposomal bupivacaine improves pain scores and reduces opioid use after total knee arthroplasty: results of a randomized controlled trial. J Arthroplasty. 2017. doi:10.1016/j.arth.2017.07.024. 5. Data on fi le. 4051. Parsippany, NJ: Pacira Pharmaceuticals, Inc.: December 2017. Indication 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 Specifi c 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 For more information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727). Please see brief summary of Prescribing Information on adjacent page. Full Prescribing Information is also available at www.EXPAREL.com. THE PRESIDENT HAS DECLARED A PUBLIC HEALTH EMERGENCY. NOW WHAT? OPIOID CRISIS IN AMERICA S P O T L I G H T O N T H E FIND OUT MORE BY VISITING EXPAREL.COM AND REQUEST TO MEET ONE OF OUR REPRESENTATIVES surgical patients prescribed an opioid may go on to long-term use or abuse 2 † 1in15 new heroin users started out by misusing opioid pain relievers 3‡ 4 of5 HOSPITAL OPERATING ROOMS ACROSS THE COUNTRY ARE FUNCTIONING AS UNINTENDED GATEWAYS TO OPIOID ADDICTION © 2 018 Pacira Pharmaceuticals, Inc., Parsippany, NJ 0 70 5 4 PP-E X-US-3 3 8 5 1/18 99 % of surgical patients receive opioids to manage postsurgical pain 1 *

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