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days to go: ASP+6% CMS reimbursement for proven non-opioids used in all outpatient surgical settings is coming January 1, 2025.

The efficacy of EXPAREL in orthopedic surgery

Adductor Canal Block

EXPAREL vs bupivacaine HCl in TKA (adductor canal pivotal trial)1

Superior pain control and reduced opioid consumption through 4 days vs bupivacaine HCl

Superior PAIN CONTROL

vs bupivacaine HCl

cumulative pain scores (P<0.0074)

23%

FEWER OPIOIDS*

total postsurgical opioid consumption (P<0.0071)

Significantly better pain control vs bupivacaine HCl postsurgery on1,2:

DAY 2

(P=0.0018)

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DAY 3

(P=0.0191)

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DAY 4

(P=0.0404)

The adductor canal block pivotal trial investigated EXPAREL admixed with bupivacaine HCI versus bupivacaine HCl alone, administered as an adductor canal block (ACB) for total knee arthroplasty (TKA). Prior to the surgical procedure, patients received 133 mg (10 mL) of EXPAREL admixed with 50 mg (10 mL) of 0.5% bupivacaine HCl OR 50 mg (10 mL) of 0.5% bupivacaine HCl mixed with 10 mL normal saline via saphenous nerve (adductor canal) block. All patients also received 37.5 mg (15 mL) of 0.25% immediate-release bupivacaine HCl as an infiltration between the popliteal artery and capsule of the knee (IPACK) block immediately following study drug administration.

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

EXPAREL vs bupivacaine HCI in TKA3

78%

FEWER OPIOIDS*

overall opioid consumption (P<0.005)

Significantly better

PAIN CONTROL

cumulative pain scores (P<0.04)

1 out of 10 patients who received EXPAREL was opioid-free

10% with EXPAREL (n=70)

vs (P<0.01)

0% with BUPIVACAINE HCI (n=69)

Results from a phase 4, double-blind, randomized, 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: area under the curve (AUC) of visual analog scale 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 adverse events were similar between treatment groups. The most common adverse events were nausea, dizziness, and muscle spasms.

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

TKA, total knee arthroplasty.

EXPAREL vs bupivacaine HCl in foot and ankle surgery (sciatic nerve block in the popliteal fossa pivotal trial)4

Superior pain control and reduced opioid consumption through 4 days vs bupivacaine HCl

Superior PAIN CONTROL

vs bupivacaine HCl

cumulative pain scores (P<0.00001)

61%

FEWER OPIOIDS*

total postsurgical opioid consumption (P<0.00001)

5x more participants in the EXPAREL group were opioid free through 4 days

The sciatic nerve block in the popliteal fossa pivotal trial investigated EXPAREL versus bupivacaine HCl administered via sciatic nerve block in the popliteal fossa in participants undergoing bunionectomy, a common and well-validated surgical model often used to study postsurgical pain for foot and ankle procedures. Prior to the surgical procedure, patients received 133 mg (10 mL) of EXPAREL mixed with 20 mL saline OR 50 mg (20 mL) of 0.25% bupivacaine HCl mixed with 10 mL saline via sciatic nerve block in the popliteal fossa. All patients received 100 mg (20 mL) of 0.5% immediate-release bupivacaine HCl as a Mayo field block after study drug administration

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

EXPAREL vs placebo in ISBP nerve block for total shoulder arthroplasty and rotator cuff repair study5*

78%

FEWER OPIOIDS†

overall opioid consumption (P<0.0001)

Significantly better

PAIN CONTROL

cumulative pain scores (P<0.0001)

Significantly more patients were opioid-free with EXPAREL

23% at 24 HOURS (P<0.0001)

AND

13% at 48 hours (P=0.008)

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.

*Rescue opioids for pain were available upon patient request.

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

AUC, area under the curve; ISBP, interscalene brachial plexus; VAS, Visual Analogue Scale.

The efficacy of EXPAREL in obstetric surgery

EXPAREL TAP block vs bupivacaine TAP block in C-section study6

52%

FEWER OPIOIDS at 72 hours*

overall opioid consumption (P<0.0117)†

Comparable PAIN CONTROL

through 72 hours

overall opioid consumption

Results from a prospective, 13-site, multicenter, randomized clinical trial, EXPAREL significantly improved postsurgical recovery when used in a TAP block after C-section. Primary end point: EXPAREL reduced opioid consumption by 52%, compared with standard bupivacaine, over 72 hours and maintained a significant opioid-minimizing effect over 2 weeks.

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

†The reduction in opioid consumption continued for two weeks postpartum.

TAP, transversus abdominis plane; VAS, Visual Analogue Scale.

The efficacy of EXPAREL in colorectal surgery

EXPAREL vs placebo in hemorrhoidectomy7,8

Significantly lower

OPIOID USE*

45% lower overall opioid consumption (P=0.0006)†

Significantly better

PAIN CONTROL

30% lower cumulative pain scores (P<0.0001)†

3 out of 10 patients who received EXPAREL were opioid-free7

28% with EXPAREL (n=95)

vs (P<0.0008)

10% with PLACEBO (n=94)

Results from a phase 3, multicenter, randomized double-blind, placebo-controlled trial that evaluated the efficacy of 166 mg (20 mL) of EXPAREL in 186 patients 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) of morphine administered intramuscularly) was available to all patients.

*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.

ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.

Important Notice

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.

References

  1. Gadsden J, Hamilton M, Schwartz G, et al. Liposomal bupivacaine via adductor canal block after total knee arthroplasty: a randomized, double-blind, phase 3 trial. Poster presented at: 48th Annual Regional Anesthesiology and Acute Pain Medicine Meeting; April 20, 2023; Hollywood, FL. Poster 4381.
  2. Data on File. 9728. Parsippany, NJ: Pacira BioSciences, Inc.; November 2023.
  3. 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.
  4. Schwartz G, Gadsden JC, Gonzales J, et al. A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy. J Clin Anesth. 2024;94:111402.
  5. 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.
  6. Nedeljkovic SS, Kett A, Vallejo MC, et al. Transversus abdominis plane block with liposomal bupivacaine for pain after cesarean delivery in a multicenter, randomized, double-blind, controlled trial. Anesth Analg. 2020;131(6):1830-1839.
  7. 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.
  8. Data on File. 2363. Parsippany, NJ: Pacira BioSciences, Inc.; March 2017.
SEE MORE

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.

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