Important Notice

This site is for informational purposes only and is intended to address medical questions from healthcare professionals in the United States.

For medical inquiries related to EXPAREL, submit a request to Medical Information or call 1-855-RX-EXPAREL (1-855-793-9727).

These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.

References

1. Data on file. 2125. Parsippany, NJ: Pacira Pharmaceuticals, Inc.; January 2017.
2. How DepoFoam^® works. Pacira Pharmaceuticals, Inc. website. http://www.pacira.com/depofoam-platform/how-it-works.php. Accessed May 26, 2016.
3. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559.
4. Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33(4):383-391.
5. Ilfeld BM, Loland VJ, Sandhu NS, Suresh PJ, Bishop MJ, Donohue MC. Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block. Anesth Analg. 2012;115(3):721-727.
6. Kinder R, Hsiung R. Overview of peripheral nerve blocks. In: Chu LF, Fuller A, eds. Manual of Clinical Anesthesiology. 1st ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
7. Process for handling elastomeric pain relief balls (ON-Q PainBuster and others) requires safety improvements. Institute for Safe Medication Practices website. https://www.ismp.org/newsletters/acutecare/articles/20090716.asp. Accessed May 26, 2016.
8. I-Flow ON-Q pump with ONDEMAND bolus button class I recall of risk of continuous infusion at a ration greater than expected. US Food and Drug Administration website. http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm317851.htm. Accessed May 26, 2016.
9. Continuous peripheral nerve blocks in outpatients. NYSORA–The New York School of Regional Anesthesia website. http://www.nysora.com/mobile/regional-anesthesia/foundations-of-ra/3055-continuous-peripheral-nerve-blocks-in-outpatients.html. Accessed May 26, 2016.
10. Frost & Sullivan. New Opportunities for Hospitals to Improve Economic Efficiency and Patient Outcomes: The Case of EXPAREL™, a long-acting, non-opioid local analgesic. http://www.frost.com/prod/servlet/cpo/252218999. Accessed May 26, 2016.

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

Please refer to full Prescribing Information.

Medical Information

Non-US healthcare professionals can submit a request to medinfo@pacira.com

If you are not a healthcare professional, please discuss any questions you have regarding your health or treatment with your physician, pharmacist, nurse, or other healthcare professional.

Important information about EXPAREL^®

The FDA confirms that EXPAREL has always been approved for "administration into the surgical site to produce postsurgical analgesia" for use in a variety of surgeries not limited to those studied in its pivotal trials.

Prescribing Information Press Release Rescission Letter

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