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EXPAREL® (bupivacaine liposome injectable suspension) is changing the way we treat postsurgical pain

Low- or no-opioid pain control is possible with EXPAREL

EXPAREL is a local anesthetic administered at the time of surgery to control pain and reduce or eliminate the use of opioids for acute postsurgical pain. When injected into the surgical site, EXPAREL turns off the body’s pain signals, numbing the area where surgery has occurred for several days following the procedure. To date, EXPAREL has been used in over 14 million adult patients.

EXPAREL is the only non-opioid option approved to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block.*

*Safety and efficacy have not been established in other nerve blocks.

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EXPAREL CAN BE USED IN A WIDE RANGE OF PROCEDURES ACROSS SPECIALTIES

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GENERAL

Procedures:

Bariatric, Colon, Hemorrhoid, Hernia, Kidney, Stomach

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Oral and Maxillofacial

Procedures:

Implants, TMJ, Wisdom Teeth Extraction

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ORTHOPEDIC

Procedures:

Ankle, Foot, Hand, Hip, Knee, Shoulder, Spine

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PEDIATRIC

Procedures:

ACL, Scoliosis/Spine, Tonsillectomy, Wisdom Teeth

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women’s health

Procedures:

Breast, Cesarean Delivery (C-Section), Fibroid, Hysterectomy

EXPAREL provides significant long-lasting pain control while reducing opioid use*

EXPAREL vs bupivacaine HCI in total knee arthroplasty (TKA)1

78%

FEWER OPIOIDS

overall opioid consumption
over 48 hours

P<0.005

Significantly better

PAIN CONTROL

cumulative pain scores
from 12 to 48 hours

P<0.04

1 out of 10 patients who received EXPAREL was opioid-free through days 2 & 3

10% with EXPAREL (n=70)

vs

0% with Bupivacaine HCl (n=69)

P<0.01

*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials. Results from a phase 4, double-blind, randomized, placebo-controlled trial that compared the efficacy and safety of EXPAREL 266 mg (20 mL) (n=70) and bupivacaine HCl (n=69) in a TKA study. Primary end points: AUC of VAS pain intensity scores 12 to 48 hours postsurgery; total opioid consumption 0 to 48 hours postsurgery. Rescue opioids for pain were available upon patient request. Rates and types of AEs were similar between treatment groups. The most common AEs in the EXPAREL group were nausea, muscle spasms, and vomiting.

EXPAREL vs placebo in hemorrhoidectomy2

45%

Fewer Opioids

overall opioid consumption
over 72 hours

P=0.0006†

Significantly better

PAIN CONTROL

cumulative pain scores
over 72 hours

P<0.0001†

3 out of 10 patients who received EXPAREL were opioid-free through day 3

28% with EXPAREL (n=94)

vs

10% with placebo (n=93)

P<0.0008

*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials. †Results vs placebo through 72 hours. Opioid reduction calculated based on geometric mean ratio. Results from a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial that evaluated the safety and efficacy of EXPAREL 300 mg (30 mL) (n=95) and placebo (n=94) in subjects undergoing 2- or 3-column excisional hemorrhoidectomy. Primary end point: cumulative pain score reflected in AUC of numeric rating scale through 72 hours. Placebo was preservative-free saline for injection. Opioid rescue medication (up to 10 mg morphine administered intramuscularly) was available to all patients. Rates of AEs were comparable between groups. The most common AEs were gastrointestinal.

EXPAREL vs placebo in INTERSCALENE BRACHIAL PLEXUS nerve block
for total shoulder arthroplasty and rotator cuff repair study3†

78%

FEWER OPIOIDS

postsurgical opioid consumption
over 48 hours

P<0.0001

Significantly better

PAIN CONTROL

cumulative pain scores
over 48 hours

P<0.0001

1 out of 10 patients who received EXPAREL were opioid-free through day 2

13% at 48 hours (n=69)

vs

1% with placebo (n=71)

P=0.008

*The clinical benefit of the decrease in opioid consumption was not demonstrated in the pivotal trials. †Rescue opioids for pain were available upon patient request. Results from a phase 3, multicenter, controlled trial that compared the postsurgical analgesia efficacy, safety, and pharmacokinetics of EXPAREL 133 mg (10 mL) and placebo in patients undergoing total shoulder arthroplasty or rotator cuff repair. Primary and secondary end points: pain intensity through 48 hours postsurgery, as measured by AUC of VAS pain intensity scores, and total postsurgical opioid consumption.
Learn More About EXPAREL
Prescribing information

Indication

EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.

Important Safety Information

  • EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
  • Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via nerve block were nausea, pyrexia, headache, and constipation.
  • Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.
  • Do not admix lidocaine or other non-bupivacaine local anesthetics with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine.
  • EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for nerve blocks, 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.

Warnings and Precautions Specific to EXPAREL

  • Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
  • EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block, or intravascular or intra-articular use.
  • The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.

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 paresthesia. 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.
  • Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.

Please refer to full Prescribing Information.

For more information, please visit www.EXPARELPRO.com or call 1-855-793-9727.

References

  1. Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local infiltration analgesia with liposomal bupivacaine improves pain scores and reduces opioid use after total knee arthroplasty: results of a randomized controlled trial. J Arthroplasty. 2018;33(1):90-96. doi:10.1016/j.arth.2017.07.024.

  2. 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.

  3. Patel MA, Gadsden JC, Nedeljkovic SS, et al. Brachial plexus block with liposomal bupivacaine for shoulder surgery improves analgesia and reduces opioid consumption: results from a multicenter, randomized, double-blind, controlled trial. Pain Med. 2020;21(2):387-400.