Use a multimodal approach to reduce postsurgical pain and opioid use

Important Notice

• This site is intended to provide medical and product information to health care professionals in the United States.
• To report an adverse event, email drugsafety@pacira.com or call 1-855-793-9727.
• For medical inquiries related to EXPAREL, submit a request to Medical Information or call 1-855-793-9727.
• These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.

Indication

Important Safety Information

• EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
• Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via nerve block were nausea, pyrexia, headache, and constipation.
• Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.
• Do not admix lidocaine or other non-bupivacaine local anesthetics with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine.
• EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for nerve blocks, 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, sciatic nerve block in the popliteal fossa, and adductor canal 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 full Prescribing Information.

References

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2. Dumestre DO, Redwood J, Webb CE, Temple-Oberle C. Enhanced recovery after surgery (ERAS) protocol enables safe same-day discharge after alloplastic breast reconstruction. Plast Surg (Oakv). 2017;25(4):249-254.
3. Modesitt SC, Sarosiek BM, Trowbridge ER, et al. Enhanced recovery implementation in major gynecologic surgeries: effect of care standardization. Obstet Gynecol. 2016;128(3):457-466.
4. Lemanu DP, Singh PP, Berridge K, et al. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013;100(4):482-489.
5. Correll D. Chronic postoperative pain: recent findings in understanding and management. F1000Res. 2017;6:1054.
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7. AAOMS. Opioid prescribing: acute and postoperative pain management. https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/opioid_prescribing.pdf Reviewed 2017. Accessed Aug 18, 2020.
8. Carmichael JC, Keller DS, Baldini G, et al. Clinical practice guidelines for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017;60(8):761-784.
9. Temple-Oberle C, Shea-Budgell MA, et al; ERAS Society. Consensus review of optimal perioperative care in breast reconstruction: Enhanced Recovery after Surgery (ERAS) Society recommendations. Plast Reconstr Surg. 2017;139(5):1056e-1071e.
10. Nelson G, Bakkum-Gamez J, Kalogera E, et al. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019;29(4):651-668.
11. Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, et al. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS^®) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019;55(1):91-115.