Additional Safety Information

The safety of EXPAREL® has been evaluated in 10 clinical trials in over 823 patients; the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting.

Please see Important Safety Information at the bottom of this page.

In EXPAREL clinical trials

  • No QTc prolongation as evaluated in 2 ICH E14-compliant ECG studies1
  • No signal of any cardiac events of clinical importance seen during the clinical development program2
    • Of the 823 patients in the wound infiltration clinical trials, the most common treatment-emergent adverse events were tachycardia (3.9%) and bradycardia (1.6%)

Additional safety findings

  • No events of chondrolysis
  • No hepatic dosing adjustment for mild to moderate disease
  • No abnormal findings reflecting improper wound healing3

Ensuring patient safety with any local anesthetic

Inspect Product Vials and Label All Syringes Inspect all vials before use to eliminate medications errors. Label all prepared syringes to avoid confusion.
Monitor for Signs of Toxicity Monitoring of cardiovascular and neurologic status, as well as vital signs, should be performed during and after injection of all local anesthetics, including EXPAREL.
Know What to Look for

Warning signs of nervous system toxicity include:
Restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness

Warning signs of cardiovascular toxicity include:
Depressed cardiac conductivity and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure

Know What to Do

Although no formal studies have been conducted, use of a 20% lipid emulsion has been shown in numerous case reports to reverse local anesthetic toxicity.

In cardiac arrest secondary to local anesthetic toxicity that is unresponsive to standard therapy, intravenous administration of a lipid (such as Intralipid® 20%) is recommended by the American Society of Regional Anesthesia.4

Video about DepoFoam®

Watch this short animation to see how DepoFoam works.

View

Take the Opioid Quiz

Test your knowledge about opioids and the opioid crisis in America.

Start

Important Notice

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

To report an adverse event, e-mail drugsafety@pacira.com or dial 1-855-RX-EXPAREL (1-855-793-9727).

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. Naseem A, Harada T, Wang D, et al. Bupivacaine extended release liposome injection does not prolong QTc interval in a thorough QT/QTc study in healthy volunteers. J Clin Pharmacol. 2012;52(9):1441-1447.
  2. Bergese SD, Onel E, Morren M, Morganroth J. Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg Anesth Pain Med. 2012;37(2):145-151.
  3. Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011;28(9):776-788.
  4. Checklist for Treatment of Local Anesthetic Systemic Toxicity. American Society of Regional Anesthesia website. http://www.asra.com/checklist-for-local-anesthetic-toxicity-treatment-1-18-12.pdf. Accessed May 26, 2016.

Important Safety Information

Warnings and Precautions Specific to EXPAREL

Warnings and Precautions for Bupivacaine-Containing Products

Please refer to full Prescribing Information.

Important Safety Information

Medical Information

US healthcare professionals Click Here

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.

"We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate."

- Dave Stack, Chief Executive Officer and Chairman of Pacira

The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials.

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.

PATIENTS

Click Here >

to continue to the Patient site.

DOCTORS

Click Here >

to continue to the HCP site.

EXPAREL® (bupivacaine liposome injectable suspension) Sign Up

Sign up to receive updates on EXPAREL.

 
Providing the optional information about you below enables us to provide information geared to your needs.
Yes, I would like to receive periodic updates about EXPAREL via e-mail. I agree to the Privacy Policy
 

Thank you! Your registration is complete.

Sorry. There was an error submitting your request. Please try again at another time.

Sorry. The connection to the server was lost. Please try again at another time.