WHAT IS EXPAREL?
EXPAREL is a non-opioid analgesic that provides proven, long-lasting postsurgical pain control with decreased opioid consumption when used as part of a multimodal pain management regimen.* Multimodal therapy uses a combination of non-opioid pain medications before, during, and after surgery to effectively control postsurgical pain while helping patients remain alert and comfortable during their recovery.1 Multimodal therapy is advocated by leading health care organizations such as the American Pain Society, the American Society of Anesthesiologists, the American Dental Association, the American College of Surgeons, and the Centers for Disease Control and Prevention.1-3
EXPAREL uses a unique DepoFoam® drug delivery system designed to deliver bupivacaine — a proven non-opioid medication—over time. This slow release makes it possible for EXPAREL to provide long-lasting postsurgical pain control with just a single dose.4 Non-opioid EXPAREL also has a proven safety and tolerability profile. Developed by Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX), EXPAREL was approved by the US Food and Drug Administration in October 2011. The product became commercially available in April 2012.5 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. More than 5 million patients have received EXPAREL since 2012.
WHAT CAN CLINICIANS AND PATIENTS EXPECT WITH EXPAREL?
When used as part of a multimodal pain management regimen, clinicians and patients can expect to see long-lasting pain control with a decrease in opioid consumption following a single dose of EXPAREL.* There are no catheters, pumps, or other devices needed to deliver EXPAREL.
WHERE DOES EXPAREL FIT IN THE MANAGEMENT OF POSTSURGICAL PAIN?
Today, clinicians are taking a proactive stance against the overprescribing of opioids. EXPAREL is a long-acting, non-opioid, numbing medication that is administered into the tissues around the surgical site or the interscalene brachial plexus nerve to control pain and reduce the need for opioid medications.* Consider EXPAREL for patients who would benefit from an alternative to opioids: all patients whose use of opioids may impact recovery goals7; patients at risk for opioid-related adverse events (eg, sleep apnea, aged >65 years, male, obese)8-10; and patients at risk for misuse and abuse of opioids (eg, substance abuse disorder, depression).11,12 *The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.
References: 1. American Pain Society publishes clinical practice guideline for post-surgical pain management [news release]. American Pain Society website. http://americanpainsociety.org/about-us/press-room/american-pain-society-publishes-clinical-practice-guideline-for-post-surgical-pain-management. Accessed March 4, 2019. 2. American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273. 3. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016 [published correction appears in MMWR Recomm Rep. 2016;65(11):295]. MMWR Recomm Rep. 2016;65(1):1-49. 4. DepoFoam encapsulates drugs, preserving their molecular structure, and releases them over a desired period of time. Pacira Pharmaceuticals, Inc. website. https://www.pacira.com/products/depofoam. Accessed March 4, 2019. 5. Pacira Pharmaceuticals, Inc. announces commercial availability of EXPAREL® [news release]. Pacira Pharmaceuticals, Inc. website. http://investor.pacira.com/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=1680934. Accessed March 4, 2019. 6. Data on File. 5499. Parsippany, NJ: Pacira Pharmaceuticals, Inc.; February 2019. 7. Gan TJ, Robinson SB, Oderda GM, Scranton R, Pepin J, Ramamoorthy S. Impact of postsurgical opioid use and ileus on economic outcomes in gastrointestinal surgeries. Curr Med Res Opin. 2015;31(4):677-686. 8. The Joint Commission. Safe use of opioids in hospitals. https://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. Accessed March 4, 2019. 9. 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(4):383-391. 10. Minkowitz HS, Gruschkis SK, Shah M, Raju A. Adverse drug events among patients receiving postsurgical opioids in a large health system: risk factors and outcomes. Am J Health Syst Pharm. 2014;71(18):1556-1565. 11. Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and risk factors for chronic opioid use among opioid-naive patients in the postoperative period. JAMA Intern Med. 2016;176(9):1286–1293. 12. Seal KH, Shi Y, Cohen G, et al. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012;307(9):940-947.
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 infiltration 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 nonbupivacaine 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 Specific 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. Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.
Please refer to the full Prescribing Information here.
For more information, please visit https://www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727).