EXPAREL

After administration of EXPAREL, the systemic plasma levels of bupivacaine were observed for 96 hours after local infiltration, 120 hours after interscalene brachial plexus nerve block, 168 hours after sciatic nerve block in the popliteal fossa, and 168 hours after adductor canal block [see Warnings and Precautions (5.2) ] . In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration. Systemic plasma levels of bup...

14.1 Overview of Clinical Studies in Adult Patients In five multicenter, randomized, double-blinded, placebo-controlled clinical studies in adults, the efficacy of EXPAREL was established to produce postsurgical: Local analgesia via infiltration: One study evaluated the use of EXPAREL in patients undergoing bunionectomy (Study 1); the other study evaluated the use of EXPAREL in patients undergoing hemorrhoidectomy (Study 2) [see Clinical Studies (14.2) ]. Regional analgesia via perineural use: one study (Study 3) evaluated the use of EXPAREL as a brachial plexus nerve block via interscalene or...

The following serious adverse reactions have been associated with bupivacaine hydrochloride in clinical trials and are described in greater detail in other sections of the labeling: Central Nervous System Reactions [see Warnings and Precautions (5.1) ] Cardiovascular System Reactions [see Warnings and Precautions (5.1) ] Allergic Reactions [see Warnings and Precautions (5.1) ] Chondrolysis [see Warnings and Precautions (5.1) ] Methemoglobinemia [see Warnings and Precautions (5.1) ] Accidental in...

EXPAREL is contraindicated in obstetrical paracervical block anesthesia [see Use in Specific Populations (8.1) ]. While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death. EXPAREL is contraindicated in obstetrical paracervical block anesthesia ( 4 ).

Monitor cardiovascular status, neurological status, and vital signs during and after injection of EXPAREL ( 5.1 ). Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, use EXPAREL cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations ( 5.1 ). Methemoglobinemia: Cases of methemoglobinemia have been rep...

7 DRUG INTERACTIONS The toxic effects of local anesthetics are additive and concomitant use should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Overdosage (10) ] . Avoid additional use of local anesthetics within 96 hours following adminis...