EXPAREL can help reduce or eliminate the use of opioids for acute postsurgical pain

EXPAREL has multiple indications for the treatment of your patients

  • Efficacy
  • Safety
  • Dosing
  • Administration
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Efficacy

Non-opioid EXPAREL provides significant long-lasting pain control while reducing opioid use1-3

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

Results from an EXPAREL 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 pivotal trials.

Data from patients undergoing a hemorrhoidectomy2,3
Data from patients undergoing a soft-tissue surgery

Results from a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial that evaluated the safety and efficacy of 266 mg (20 mL) 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 morphine administered intramuscularly) was available to all patients.

Results vs placebo through 72 hours. Opioid reduction calculated based on geometric mean ratio.

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

EXPAREL prolonged the time to first opioid use by 14 hours2

Median time to first opioid use
Median time to first opioid use

EXPAREL can reduce or eliminate the need for opioids 2 *

In a hemorrhoidectomy study of EXPAREL vs placebo2
3 out of 10 PATIENTS WHO RECEIVED EXPAREL were opioid free

Through day 3 postsurgery

28% with exparel

(n=95)

vs

P<0.0008

10% with placebo

(n=94)
In a TKA study of EXPAREL vs bupivacaine HCI1
1 out of 10 PATIENTS WHO RECEIVED EXPAREL were opioid free

Through days 2 & 3 postsurgery

10% with exparel

(n=70)

vs

P=0.01

0% with bupivacaine HCI

(n=69)

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

Rates and types of adverse events were similar between treatment groups. The most common adverse events were nausea, dizziness, and muscle spasms.

Safety

EXPAREL has a proven safety and tolerability profile

  • Safety was evaluated in 10 wound infiltration trials
    • 823 patients underwent a variety of surgical procedures
    • EXPAREL doses ranged from 66 to 532 mg
  • Most common adverse events (AEs; incidence ≥10%) were nausea, constipation, and vomiting
  • EXPAREL demonstrated a favorable cardiac safety profile1,2
    • No detectable cardiac toxicity signal
    • No QTc prolongation, even at supratherapeutic doses
Treatment-emergent AEs (TEAEs) with an incidence ≥2%: Local infiltration placebo-controlled studies
BunionectomyHemorrhoidectomy
EXPARELPlaceboEXPARELPlacebo
System Organ Class preferred term
8 mL/1.3%
(106 mg)
(N=97)
n (%)
(N=96)
n (%)
10 mL/1.3%
(266 mg)
(N=95)
n (%)
(N=94)
n (%)
Any TEAE53 (54.6)59 (61.5)10 (10.5)17 (18.1)
Gastrointestinal disorders41 (42.3)38 (39.6)7 (7.4)13 (13.8)
Nausea39 (40.2)36 (37.5)2 (2.1)1 (1.1)
Vomiting27 (27.8)17 (17.7)2 (2.1)4 (4.3)
Nervous system disorders20 (20.6)30 (31.3)0 (0.0)0 (0.0)
Somnolence5 (5.2)1 (1.0)0 (0.0)0 (0.0)
For a complete list of TEAEs, please refer to Table 1 in the full Prescribing Information.
Bunionectomy
EXPARELPlacebo
System Organ Class preferred term
8 mL/1.3%
(106 mg)
(N=97)
n (%)
(N=96)
n (%)
Any TEAE53 (54.6)59 (61.5)
Gastrointestinal disorders41 (42.3)38 (39.6)
Nausea39 (40.2)36 (37.5)
Vomiting27 (27.8)17 (17.7)
Nervous system disorders20 (20.6)30 (31.3)
Somnolence5 (5.2)1 (1.0)
Hemorrhoidectomy
EXPARELPlacebo
System Organ Class preferred term
10 mL/1.3%
(266 mg)
(N=95)
n (%)
(N=94)
n (%)
Any TEAE10 (10.5)17 (18.1)
Gastrointestinal disorders7 (7.4)13 (13.8)
Nausea2 (2.1)1 (1.1)
Vomiting2 (2.1)4 (4.3)
Nervous system disorders0 (0.0)0 (0.0)
Somnolence0 (0.0)0 (0.0)
For a complete list of TEAEs, please refer to Table 1 in the full Prescribing Information.

EXPAREL is designed to reliably release low-dose bupivacaine over time

At the maximum recommended dose of EXPAREL, 266 mg, plasma levels of bupivacaine remain below toxicity thresholds3-5

  • Central nervous system symptoms occurred at a plasma concentration of ≈2000 ng/mL with bupivacaine HCl4
  • Cardiac toxicity is associated with blood levels of ≥4000 ng/mL5
Review detailed pharmacokinetic data

Dosing

Choose the appropriate dose

EXPAREL is available as 266 mg (20 mL) and 133 mg (10 mL) single-dose use vials. The recommended dose of EXPAREL is based on

Size of surgical site

Volume needed to cover the width and depth of site

Patient factors that could impact safety of an amide local anesthetic

EXPAREL is intended for single-dose administration only, and maximum dose should not exceed 266 mg (20 mL).

Rate of absorption and onset of action of EXPAREL may vary based on vascularity of the tissue, patient factors, timing of administration, and administration technique.

Determine the right volume to cover the surgical site

  • Consider the size of the surgical site and the neuroanatomy
  • Expand the volume to disperse liposomes throughout the surgical site
  • Enough multivesicular liposomes must be available at the pain receptors to continuously release bupivacaine, ensuring long-lasting analgesia
  • Transversus abdominis plane (TAP) blocks require large volumes of local anesthetic to obtain reliable blockade

266 mg (20 mL) EXPAREL can be expanded for large surgical sites

  • Expand with normal (0.9% ) saline or lactated Ringer’s solution
  • Add up to 280 mL for a total of 300 mL; a 1:14 ratio

133 mg (10 mL) EXPAREL should be considered for small surgical sites

  • Sites where 20 mL of EXPAREL is too much volume
  • Sites where 133 mg (≈370 liposomes) sufficiently covers the area

Consider the size of the surgical site and neuroanatomy to determine expansion volume

Examples of expansion volumes by TAP procedure

For early onset, admix with bupivacaine HCI

Example of admixing

Bupivacaine HCl may be administered immediately before EXPAREL or admixed in the same syringe

  • Keep a 1:2 ratio of the milligram dose of bupivacaine HCl to EXPAREL. In determining this ratio, consider
    • One 20 mL vial of EXPAREL contains 266 mg of free-base bupivacaine, which is molar equivalent to 300 mg of bupivacaine HCl
    • One 30 mL vial of 0.5% bupivacaine contains 150 mg of bupivacaine HCI
  • Admixing may impact the pharmacokinetic/pharmacodynamic properties of EXPAREL; the effect is concentration dependent

Administration

Administer EXPAREL differently than bupivacaine HCl

Bupivacaine HCl is an aqueous solution

  • Readily diffuses into surrounding tissue and spreads throughout site
  • Requires fewer injections than EXPAREL for adequate pain-receptor coverage
  • Utilizes a consistent injection technique throughout the surgical site

EXPAREL is a suspension composed of multivesicular liposomes that carry bupivacaine

  • Stays precisely where placed; does not readily diffuse into surrounding tissue
  • Requires more injections than other local anesthetics to ensure adequate coverage

Proper local infiltration technique for optimal postsurgical pain control

Inject deep into the tissue vs surgical site

Surgical-site inflitration

  • Utilizing a moving needle technique, EXPAREL should be injected slowly (generally 1 to 2 mL per injection) with frequent aspiration to check for blood and minimize the risk of inadvertent intravascular injection
  • Infiltrate above and below fascia and into subcutaneous tissues
  • Aspirate frequently to minimize risk of intravascular injection
  • Use a 25-gauge or larger-bore needle to maintain the structural integrity of liposomes

In breast surgery, field block infiltration or fascial plane infiltration can be an effective technique in a multimodal analgesic strategy1,2

  • A PECS (ultrasound-guided medial and lateral pectoralis nerve) block is a less invasive technique for providing analgesia after breast surgery compared with standard approaches such as thoracic epidural, paravertebral, intercostal nerve, and interpleural blocks2,3
  • In PECS I and PECS II field infiltration, ultrasound guidance can be used to identify the appropriate fascial plane(s) and to deposit local anesthetic to provide regional analgesia2
    • PECS blocks are applied in the pectoral and axillary regions, with the muscles in both regions innervated by the brachial plexus3
  • A PECS block can be administered by the anesthesiologist or surgeon; direct injection during open surgery is also possible2
  • These techniques provide effective analgesia after breast surgery and, unlike thoracic paravertebral and epidural blocks, are not associated with sympathetic block2

Areas covered by a PECS I or PECS II block

External anterior view of areas covered by PECS I and PECS II nerve blocks

  • PECS I block Devised to anesthetize the medial and lateral pectoral nerves, which innervate the pectoralis muscles3.
  • PECS II block Extends the block to provide blockade of the upper intercostal nerves3.

Consider the neuroanatomy to target the appropriate nerves for a PECS block

Interior view of nerves to target with a PECS block

PECS I block
  • The lateral and medial pectoral nerves lie in the fascial plane between the pectoralis major and minor muscles2.
PECS II block
  • Spinal nerves T2-T4 lie in the fascial plane between the pectoralis minor and serratus anterior muscles2.

Internal sagittal view of where to inject local anesthetic

  • PECS I block Injection between pectoralis major and minor muscles2.
  • PECS II block Injection between the pectoralis muscles and a second injection between the serratus anterior and pectoralis minor muscles2.

Learn how to perform PECS blocks with EXPAREL by procedure type:

Abdominal-wall field blocks are part of a multimodal strategy for postsurgical pain management1

  • Abdominal-wall field blocks use a local anesthetic to provide effective regional analgesia for a range of procedures2
  • Transversus abdominis plane (TAP) field blocks provide analgesia to the anterior abdominal wall and involve administration of a local anesthetic into the fascial plane between the transversus abdominis and internal oblique muscles1
  • Approaches to abdominal-wall field blocks have been evolving
    • The TAP block was originally described as a landmark-guided field block based on the lumbar triangle1
    • Ultrasound-guided TAP blocks allow visualization of the needle and local anesthetic in the plane1
    • Additional approaches have been and continue to be developed, including subcostal TAP, 4-point TAP, rectus sheath blocks, and quadratus lumborum (QL) blocks1,3
  • TAP blocks can be administered by the anesthesiologist or the surgeon2

Abdominal field blocks can achieve sensory block in one of several areas

Comparison of sensory blocks achieved

  • Classic TAP block4 Yellow semicircle over the lower abdomen (dermatomes T10 to L1)
  • Subcostal TAP block4 Can vary, but approximately the shaded gray in the upper abdominal quadrant (dermatomes T6 to T10-T12)
  • Rectus sheath block5 Narrow black oval over abdominal midline (dermatomes T6 to T12)
  • Bilateral 4-point TAP block5 Green shape overlapping the areas of coverage of classic and subcostal TAPs (dermatomes T6 to T12)
  • QL block3 Large purple circle over abdominal midline (dermatomes Th6 to L1)

Ultrasound-guided infiltration of the appropriate nerves can achieve a range of sensory blocks

Images used with permission from Abdominal Best Infiltration Practices and International Guidelines Central. Artwork created by Kellie M. Holoski, 2016.