The Safety of EXPAREL ® (Bupivacaine Liposome Injectable Suspension) Administered by Peripheral Nerve Block in Rabbits and Dogs
Table 1
Injection site microscopic findings in rabbits (combined sexes).
Day 3
Observations
Severity grade
Saline
EXP 9 mg/kg
EXP 18 mg/kg
EXP 30 mg/kg
Bsol 9 mg/kg
Brachial plexus, distal
Hemorrhage
minimal
0
0
1
0
1
moderate
0
1
1
0
0
Inflammation, granulomatous
minimal
0
3
1
1
0
Inflammation, subacute
minimal
0
0
0
0
1
Brachial plexus, middle
Hemorrhage
minimal
0
2
0
1
0
moderate
0
1
0
0
0
Inflammation, granulomatous
minimal
0
1
1
3
0
Inflammation, subacute
minimal
0
0
1
0
0
Brachial plexus, proximal
Hemorrhage
minimal
0
0
1
1
0
mild
0
1
0
0
0
moderate
0
1
0
0
0
Inflammation, granulomatous
minimal
0
0
1
1
0
Inflammation, subacute
minimal
0
1
1
0
0
Day 15
Brachial plexus, distal
Hemorrhage
minimal
0
1
1
0
0
mild
0
0
1
1
0
moderate
0
0
0
1
0
Inflammation, subacute
minimal
0
1
0
0
0
Brachial plexus, middle
Fibrosis
minimal
0
0
0
0
1
Hemorrhage
minimal
0
1
1
0
2
mild
0
0
0
0
1
Inflammation, granulomatous
mild
0
0
1
0
0
Inflammation subacute
minimal
0
1
0
0
0
Mineralization
minimal
0
0
1
0
0
Brachial plexus, proximal
Hemorrhage
minimal
0
2
0
0
0
mild
0
1
1
1
0
moderate
0
0
0
0
1
EXP, EXPAREL (bupivacaine liposome injectable suspension); Bsol, bupivacaine solution. Note: number of animals examined was 4/group on Day 3 or Day 15.