EXPAREL in oral/maxillofacial surgery

ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.

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

1. DentaVox: over 60% of people worldwide suffer from dental fear, 4% have never visited a dentist. https://www.biospace.com/article/-dentavox-over-60-percent-of-people-worldwide-suffer-from-dental-fear-4-percent-have-never-visited-a-dentist/ Published September 13, 2018. Accessed July 26, 2022.
2. New research shows vast majority of oral surgery patients would choose non-opioid medication to treat postsurgical pain if given the option. https://www.globenewswire.com/news-release/2017/05/03/978035/0/en/New-Research-Shows-Vast-Majority-of-Oral-Surgery-Patients-Would-Choose-Non-opioid-Medication-to-Treat-Postsurgical-Pain-if-Given-the-Option.html?culture=fr-ca Published May 3, 2017. Accessed August 26, 2022.
3. Miech R, Johnston L, O'Malley PM, Keyes KM, Heard K. Prescription opioids in adolescence and future opioid misuse. Pediatrics. 2015;136(5):e1169-e1177.
4. Lieblich SE, Misiek D, Olczak J, Fleck H, Waterman F. A retrospective cross-sectional study of the effect of liposomal bupivacaine on postoperative opioid prescribing after third molar extraction. J Oral Maxillofac Surg. 2021;79(7):1401-1408.e1.
5. Patel RA, Jablonka EM, Rustad KC, et al. Retrospective cohort-based comparison of intraoperative liposomal bupivacaine versus bupivacaine for donor site iliac crest analgesia during alveolar bone grafting. J Plast Reconstr Aesthet Surg. 2019;72(12):2056-2063.
6. Iero PT, Mulherin DR, Jensen O, Berry T, Danesi H, Razook SJ. A prospective, randomized, open-label study comparing an opioid-sparing postsurgical pain management protocol with and without liposomal bupivacaine for full-arch implant surgery. Int J Oral Maxillofac Implants. 2018;33(5):1155-1164.
7. Gulko JA, Carr BR, Neal TW, et al. Does liposomal bupivacaine injection decrease postoperative opioid usage following bimaxillary surgery? J Oral Maxillofac Surg. 2021;79(10):e69-e70.
8. American Association of Oral and Maxillofacial Surgeons (AAOMS). Opioid prescribing: acute and postoperative pain management. https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/opioid_prescribing.pdf Accessed August 25, 2020.