EXPAREL in obstetrics/gynecologic surgery

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. Nedeljkovic SS, Kett A, Vallejo MC, et al. Transversus abdominis plane block with liposomal bupivacaine for pain after cesarean delivery in a multicenter, randomized, double-blind, controlled trial. Anesth Analg. 2020;131(6):1830-1839.
2. Hutchins J, Vogel RI, Ghebre R, et al. Ultrasound-guided subcostal transversus abdominis plane infiltration with liposomal bupivacaine for patients undergoing robotic-assisted hysterectomy: a retrospective study. Int J Gynecol Cancer. 2015;25(5):937-941.
3. Baker BW, Villadiego LG, Lake YN, et al. Transversus abdominis plane block with liposomal bupivacaine for pain control after cesarean delivery: a retrospective chart review. J Pain Res. 2018;11:3109-3116.
4. Society of Obstetric Anesthesia and Perinatology (SOAP) Enhanced Recovery After Cesarean (ERAC) Consensus Statement. Society of Obstetric Anesthesia and Perinatology website. https://soap.org/SOAP-Enhanced-Recovery-After-Cesarean-Consensus-Statement.pdf Accessed Aug 25, 2020.
5. Nelson G, Bakkum-Gamez Z, 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.
6. 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.
7. Chapman JS, Roddy E, Ueda S, Brooks R, Chen LL, Chen LM. Enhanced recovery pathways for improving outcomes after minimally invasive gynecologic oncology surgery. Obstet Gynecol. 2016;128(1):138-144.
8. Hedderson M, Lee D, Hunt E, et al. Enhanced recovery after surgery to change process measures and reduce opioid use after cesarean delivery: a quality improvement initiative. Obstet Gynecol. 2019;134(3):511-519.
9. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 750: Perioperative pathways: enhanced recovery after surgery. Obstet Gynecol. 2018;132(3):e120-e130.
10. Lefkowits C, Duska L. Opioid use in gynecologic oncology; balancing efficacy, accessibility and safety: an SGO clinical practice statement. Gynecol Oncol. 2017;144(2):232-234.