Dosing EXPAREL®

Dosing and preparing EXPAREL

  • EXPAREL is intended for single-dose administration only and is available as a 20 mL single-use vial (1.3%, 266 mg/20 mL)
  • EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia
    • EXPAREL can be used in a variety of surgeries
    • The indication of EXPAREL is not limited to any specific surgery type
  • The recommended dose of EXPAREL is based on the following factors:
    • Size of the surgical site
    • Volume required to cover the area
    • Individual patient factors that may impact the safety of an amide local anesthetic
    • Maximum dose should not exceed 266 mg (one 20 mL vial)
  • Volume can be expanded to accommodate larger surgical sites
    • A 20 mL vial of EXPAREL can be administered undiluted or expanded up to a total of 300 mL with normal (0.9%) saline or lactated Ringer’s solution
  • Bupivacaine HCl may be administered immediately before EXPAREL or admixed in the same syringe, as long as the ratio of the milligram dose of bupivacaine HCl to EXPAREL does not exceed 1:2
    • In determining this ratio, consider the following:
      • One 20 mL vial of EXPAREL contains 266 mg of free base bupivacaine; 266 mg of free base bupivacaine is molar equivalent to 300 mg of bupivacaine HCl
      • One 30 mL vial of 0.5% bupivacaine contains 150 mg of bupivacaine HCl
    • Admixing may impact the pharmacokinetic and/or physiochemical properties of EXPAREL, and this effect is concentration dependent
    • The toxic effects of these drugs are additive and their administration should be used with caution, including monitoring for neurological and cardiovascular effects related to toxicity
  • Vials of EXPAREL should be inverted multiple times to re-suspend the particles prior to withdrawal from the vial
  • Vial is designed with a pull-off tab to easily remove the vial cap for pouring into a basin
  • Open vials should be used within 4 hours
  • Bupivacaine HCl can be used with or immediately prior to EXPAREL to provide early analgesia coverage
  • Other than bupivacaine HCl, EXPAREL should not be admixed with other drugs prior to administration
  • Different formulations of bupivacaine are not bioequivalent even if the milligram dose is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa
Dosing EXPAREL (bupivacaine liposome injectable suspension)

How supplied

EXPAREL is available in single-use vials for local administration

  • 20 mL vial, 1.3% (13.3 mg/mL) (65250-266-20) packaged in cartons of 10 (NDC 65250-266-09)

Different formulations of bupivacaine are not molar equivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL.

Contraindications

EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

Drug interactions

EXPAREL should not be admixed with lidocaine or other non-bupivacaine-based local anesthetics. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes.

Administering EXPAREL

View how to properly administer EXPAREL.

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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.

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.

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