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EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®. A single intraoperative injection given at the close of surgery delivers postsurgical pain control with reduced opioid requirements† for up to 72 hours,*1 making it a potentially suitable choice for patients who need effective pain management in the first few days after surgery,* when pain is at its worst.2
A non-opioid analgesic should be considered in populations where the use of opioids is most problematic, including:
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.1
EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia.1
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age.
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. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL.
Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. 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.
In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting.
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).
*Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures; additional studies are underway to further demonstrate the safety and efficacy in other procedures.
†The clinical benefit of the attendant decrease in opioid consumption was not demonstrated.
‡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. 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
2. Beauregard L, Pomp A, et al. Severity and impact of pain after day-surgery. Can J Anaesth.1998;45(4):304-311.
3. 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.
4. Adamson, et al. Hosp Pharm. 2011;46(6 Suppl 1):1-3.