EXPAREL is well tolerated

  • Safety was evaluated in 10 wound infiltration trials
  • 823 patients underwent a variety of surgical procedures
  • EXPAREL doses ranged from 66 mg to 532 mg
  • Most common adverse events (AEs; incidence ≥10%) were nausea, constipation, and vomiting
  • EXPAREL demonstrated a favorable cardiac safety profile1,2
  • No detectable cardiac toxicity signal
  • No QTc prolongation, even at supratherapeutic doses
Treatment-emergent AEs (TEAEs) in pivotal trials where EXPAREL rates were ≥ placebo rates and ≥5%
Bunionectomy
EXPAREL Placebo
System Organ Class
Preferred Term
106 mg
(n=97)
n (%)
 
(n=96)
n (%)
Any TEAE 42 (43.3) 38 (39.6)
Gastroinetestinal disorders 40 (41.2) 37 (38.5)
Nausea 39 (40.2) 36 (37.5)
Vomiting 27 (27.8) 17 (17.7)
Nervous system disorders 5 (5.2) 1 (1.0)
Somnolence 5 (5.2) 1 (1.0)
Hemorrhoidectomy
EXPAREL Placebo
System Organ Class
Preferred Term
266 mg
(n=95)
n (%)
 
(n=94)
n (%)
Any TEAE 2 (2.1) 4 (4.3)
Gastroinetestinal disorders 2 (2.1) 4 (4.3)
Nausea 2 (2.1) 1 (1.1)
Vomiting 2 (2.1) 4 (4.3)
Nervous system disorders 0 (0.0) 0 (0.0)
Somnolence 0 (0.0) 0 (0.0)
Data on file. Pacira Pharmaceuticals, Inc.

EXPAREL is designed to reliably release low-dose bupivacaine over time

At the maximum recommended dose of EXPAREL, 266 mg, plasma levels of bupivacaine remain below toxicity thresholds.
  • CNS symptoms occurred at a plasma concentration of ~2000 ng/mL with bupivacaine HCl3
  • The maximum tolerated dose for cardiac toxicity with bupivacaine HCl was >=4000 ng/mL2