EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®.
A non-opioid analgesic should be considered in populations where the use of opioids is most problematic, including:
- Elderly patients*
- Obese patients
- Sleep apneic patients1
The safety of EXPAREL has been evaluated in 21 clinical trials which include over 1300 subjects in the safety database. EXPAREL administered locally into the surgical site was evaluated in 10 randomized, double-blind clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 mg to 532 mg of EXPAREL.2
EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia.2
Important Safety Information
- EXPAREL is contraindicated in obstetrical paracervical block anesthesia
- In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting
- EXPAREL is not recommended to be used in the following patient population: patients <18 years old 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. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations
Warnings and Precautions Specific to EXPAREL
- EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use
- Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL
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 paresthesias. 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
For more information regarding EXPAREL, please visit the Pacira press release archives or www.EXPAREL.com.
To report an adverse event, e-mail firstname.lastname@example.org, dial 1-855-RX-EXPAREL (1-855-793-9727), or fax 1-858-408-3588 or 1-973-201-0649.
For medical inquiries related to EXPAREL, contact Medical Information at email@example.com or 1-855-RX-EXPAREL (1-855-793-9727).
*Clinical experience with EXPAREL has not identified differences in efficacy or safety between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
1. Adamson RT, Lew I, et al. Clinical and economic implications of postsurgical use of opioid therapy. Hosp Pharm. 2011;46(6 Suppl 1):1 -8.
2. Gorfine SR, Onel E, et al. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Diseases of the Colon & Rectum. 2011;54(12):1552-1559
3. Adamson, et al. Hosp Pharm. 2011;46(6 Suppl 1):1-3.