EXPAREL: Proven Safety With Controlled Bupivacaine Release
Overview
EXPAREL Provides Safe, Consistent Levels of Bupivacaine Over 4 Days1,2
At Both Maximum Doses of EXPAREL (266 mg for Infiltration and 133 mg for Interscalene Brachial Plexus Nerve Block), the Plasma Levels of Bupivacaine Remain Below Toxicity Thresholds2-5
- Central nervous system symptoms occurs at a plasma concentration of ≈2000 ng/mL with bupivacaine HCl2
- Cardiac toxicity is associated with blood levels of ≥4000 ng/mL2
- Pharmacokinetics demonstrate plasma levels of bupivacaine that can persist for 4 days3,6
- At all doses studied, plasma bupivacaine levels are maintained well below cardiac and neurotoxic levels1-4,7,8
- The rate of systemic absorption of bupivacaine is dependent upon the total dose of drug administered, the route of administration, and the vascularity of the administration site
- Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL
- Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy
EXPAREL Dosing & Procedure
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CIC FNB, continuous infusion catheter femoral nerve block; Cmax, maximum plasma concentration; CNS, central nervous system; IPACK, infiltration between the popliteal artery and capsule of the knee; ISBPNB, interscalene brachial plexus nerve block; NB, nerve block; TAP, transversus abdominis plane; TKA, total knee arthroplasty.
Additional Safety Information for EXPAREL
Effects of EXPAREL on Wound Healing
- The effects of EXPAREL on various aspects of wound healing were examined in several Phase 2 and Phase 3, randomized, double-blind clinical studies across different surgical models.12
- Overall, the analyses revealed that wound status, wound scarring, and wound healing profiles of EXPAREL were similar to that of bupivacaine HCl and better than the placebo (saline) group.12
Adverse Events
Most Common Adverse Reactions
The Most Common Adverse Reactions (≥10%) Following EXPAREL Administration via
Local Infiltration in Adults
were nausea, constipation, and vomiting
Nerve Block in Adults
were nausea, pyrexia, headache, constipation, and muscle spasms
Local Infiltration in Pediatric Patients Age 6 to Less Than 17 Years
were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, blurred vision, pruritus, and tachycardia
Active-Controlled Studies in Unapproved Populations
were hypoesthesia and paresthesia
Clinical Studies Evaluating the Safety of EXPAREL
Well-Studied Safety Profile
Over a Decade of Dependable Safety You Can Trust
Proven Safety Across Patient Populations and Procedures
| Demonstrated safety for both adult and pediatric patients2,7,13-18 | Well-tolerated with no unexpected safety concerns2,7,13,14,19,20 | No disproportionate risk of local anesthetic systemic toxicity (LAST)21 | Comparable safety profile to bupivacaine HCl |
|---|---|---|---|
| Adverse events in clinical trials were mild to moderate, with plasma bupivacaine levels safely below toxic thresholds. | Demonstrated across procedures such as orthopedics (knee, shoulder, foot, and ankle surgeries), breast reconstruction, gynecologic oncology, oral and maxillofacial surgery, and plastic surgery. | Not associated with a disproportionate risk of LAST compared to other injectable local anesthetics, based on FDA Adverse Event Reporting System data. | Consistently demonstrates a safety profile comparable to bupivacaine HCl, offering a well-tolerated option for postsurgical pain management. |
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With over a decade of real-world use, EXPAREL has demonstrated a
ROBUST SAFETY PROFILE
supported by extensive preclinical and clinical trial data across various procedures and patient populations.2,7,13-18
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