the use of exparel in abdominal-wall field blocks … · low-dose infusion with surgical transverse...

EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

Please see Important Safety Information throughout and refer to accompanying full Prescribing Information.

THE USE OF EXPAREL IN ABDOMINAL-WALL FIELD BLOCKS

IndicationEXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. 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 with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation.

If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine.

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.

Warnings and Precautions Specific to EXPARELAvoid 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, 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 ProductsCentral 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.

6 millionpatients have received non-opioid EXPAREL

since 201220

Visit www.EXPAREL.com to learn more.

Please refer to accompanying full Prescribing Information.For more information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727).References: 1. Gadsden J, Ayad S, Gonzales JJ, Mehta J, Boublik J, Hutchins J. Evolution of transversus abdominis plane infi ltration techniques for postsurgical analgesia following abdominal surgeries. Local Reg Anesth. 2015;8:113-117. 2. Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi:10.1155/2012/731645. 3. Børglum J, Jensen K. Abdominal surgery: advances in the use of ultrasound-guided truncal blocks for perioperative pain management. In: Derbel F, ed. Abdominal Surgery. Rijeka, Croatia: InTech; 2012:69-94. 4. Niraj G, Kelkar A, Powell R. Ultrasound-guided subcostal transversus abdominis plane block. International Journal of Ultrasound and Applied Technologies in Perioperative Care. 2010;1(1):9-12. 5. Go R, Huang YY, Weyker PD, Webb CA. Truncal blocks for perioperative pain management: a review of the literature and evolving techniques. Pain Manag. 2016;6(5):455-468. 6. Ultrasound-guided transversus abdominis plane and quadratus lumborum blocks. New York School of Regional Anesthesia website. https://www.nysora.com/regional-anesthesia-for-specifi c-surgical-procedures/abdomen/ultrasound-guided-transversus-abdominis-plane-quadratus-lumborum-blocks. Accessed April 23, 2019. 7. Detton AJ. Grant’s Dissector. 16th ed. Philadelphia, PA: Wolters Kluwer; 2017:109. 8. Rafi AN. Abdominal fi eld block: a new approach via the lumbar triangle. Anaesthesia. 2001;56(10):1024-1026. 9. McDonnell JG, O’Donnell BD, Farell T, et al. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007;32(5):399-404. 10. Webster K. Ultrasound guided rectus sheath block-analgesia for abdominal surgery. Update Anaesth. 2010;26:12-17. 11. Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013;27(7):2481-2486. 12. Chen CK, Tan PC, Phui VE, Teo SC. A comparison of analgesic e� cacy between oblique subcostal transversus abdominis plane block and intravenous morphine for laparoscopic cholecystectomy. A prospective randomized controlled trial. Korean J Anesthesiol. 2013;64(6):511-516. 13. Harish R. Low-dose infusion with “surgical transverse abdominis plane (TAP) block” in open nephrectomy. Br J Anaesth. 2009;102(6):889-890. 14. Hutchins J, Delaney D, Vogel RI, et al. Ultrasound guided subcostal transversus abdominis plane (TAP) infi ltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: a prospective randomized controlled study. Gynecol Oncol. 2015;138(3):609-613. 15. Børglum J, Maschmann C, Belhage B, Jensen K. Ultrasound-guided bilateral dual transversus abdominis plane block: a new four-point approach. Acta Anaesthesiol Scand. 2011;55(6):658-663. 16. Bhakta A, Glotzer O, Ata A, Tafen M, Stain S, Singh P. Analgesic e� cacy of laparoscopic guided transverse abdominis plane block using liposomal bupivacaine in bariatric surgery. Am J Surg. 2018;215(4):643-646. 17. Yarwood J, Berrill A. Nerve blocks of the anterior abdominal wall. Cont Educ Anaesth Crit Care Pain. 2010;10(6):182-186. 18. Elsharkawy H. Ultrasound-guided quadratus lumborum block: how do I do it? American Society of Regional Anesthesia and Pain Medicine website. https://www.asra.com/pain-resource/article/48/ultrasound-guided-quadratus-lumborum-blo. Accessed April 1, 2019. 19. Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011;66(4):317-318. 20. Data on fi le. 5903. Parsippany, NJ: Pacira BioSciences, Inc.; October 2019.

2

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

Important Safety InformationEXPAREL is contraindicated in obstetrical paracervical block anesthesia.


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

QL block

Rectus sheath block

Bilateral 4-point TAP block

Subcostal TAP block

Classic TAPblock

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)

Bilateral 4-point TAP block5

Green shape overlapping the areas of coverage of classic and subcostal TAPs (dermatomes T6 to T12)

Rectus sheath block5

Narrow black oval over abdominal midline (dermatomes T6 to T12)

QL block6

Large purple circle over abdominal midline (dermatomes T4 to L1)

[1/Gadsden 2015/p113/par1/ln8-12]

[2/Young 2012/p1/col1/par1/ln1-7]

[1/Gadsden 2015/p113/par1/ln10-12,p114/col2/par1/ln1-5]

[1/Gadsden 2015/p114/col1/par2/ln1,2][1/Gadsden 2015/p114/col2/par2/ln1-8]

[1/Gadsden 2015/p115/col1/par1/ln3-15][3/Borglum 2012/p72/Fig2/rows3,6]

[2/Young 2012/p3/col2/par2/ln1-5]

[4/Niraj 2010/p9/col2/par2/ln1-6]

[4/Niraj 2010/p11/col1/par5/ln2-5, 9-11]

[5/Go 2016/p2/col1/par2/ln23-29]

[5/Go 2016/p11/Table1/row6]

[6/NYSORA/p1/para1/ln11-13]

Please refer to accompanying full Prescribing Information.

3

Thoracoabdominal nerves

T7

T8

T9

T10

T11

Subcostal nerve (T12)

Iliohypogastric nerve (L1)

Ilioinguinal nerve (L2)

Superior epigastric artery

Inferior epigastric artery

Transversusabdominismuscle

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

Ultrasound-guided infiltration of the appropriate nerves can achieve a range of sensory blocks7

Target the appropriate nerves to achieve the desired abdominal-wall field block

Important Safety Information (continued)If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine.



[7/Detton/p109/Fig4.15]


4

Performing a classic TAP block in abdominal surgeries

Performing a bilateral subcostal TAP block in abdominal surgeries

Common applications/procedures for a classic TAP block• Lower abdominal surgeries (incisions below the

umbilicus)10

— Cesarean delivery2

— Colectomies11

— Hernia repair, includinginguinal hernia2

• Bilateral TAPs can be given for Pfannenstiel incisions or laparoscopic surgery below the umbilicus3,10

Administration of a bilateral subcostal TAP block In a subcostal oblique TAP block, a local anesthetic is placed between the rectus abdominis and the posterior rectus sheath or between the rectus abdominis and the transversus abdominis.5

Nerves involved4:• Dermatomes T6 to T10-T12

Med

ial

Superficial

EO, external oblique; IO, internal oblique; TA, transversus abdominis.

Deep

Administration of a classic TAP block In a classic TAP block, a local anesthetic is placed in the fascial plane between the internal oblique and the transversus abdominis muscles.8,9

Nerves involved4:• Dermatomes T10 to L1

Classic TAP block

Important Safety Information (continued)Warnings and Precautions Specific to EXPAREL (continued)EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use.


Important Safety Information (continued)Warnings and Precautions Specific to EXPARELAvoid additional use of local anesthetics within 96 hours following administration of EXPAREL.

Suggested dose and volume range of EXPAREL for a classic TAP block• Example dosing and expansion ≥30 mL per side

Bilateral classic TAP block 20 mL of 266 mg EXPAREL + 20 mL of 0.25% bupivacaine + 20 mL of normal saline

60 mL total volume

Inject 30 mL per side.

— Abdominalhysterectomy2

— Prostatectomy2

Med

ial

RA, rectus abdominis.

Lateral

Superficial

Deep

EO

IO

TA

Peritoneum

RA

TA

Peritoneum

[8/Ra� 2001/p1025/col3/par1/ln1-4][9/McDonnell 2007/p399/col2/par2/ln1,2, p400/col1/par1/all, p401/col1/par1/ln1-8]

[11/Favuzza 2013/p2483/col1/par2/ln1-6]

[10/Webster 2010/p14/col1/par2/ ln5-6]

[3/Borglum 2012/p72/Table2/col1/row1; col2/Fig2][10/Webster 2010/p14/col1/par2/ln5-6]

4/Niraj 2010/p9/col2/par2/ln1-6

[2/Young 2012/p5/Table1/rows9,14]

[2/Young 2012/p5/Table 1/rows5,10,13; p6/Table1 cont/row12; p7/Table1 cont/row2]

[2/Young 2012/p7/Table1/row1]

[2/Young 2012/p7/Table 1/row4]

5


Performing a classic TAP block in abdominal surgeries

Performing a bilateral subcostal TAP block in abdominal surgeries

Lateral

Common applications/procedures for a classic TAP block• Lower abdominal surgeries (incisions below the

umbilicus)10

— Cesarean delivery2

— Colectomies11

— Hernia repair, includinginguinal hernia2

• Bilateral TAPs can be given for Pfannenstiel incisions or laparoscopic surgery below the umbilicus3,10

Administration of a bilateral subcostal TAP block In a subcostal oblique TAP block, a local anesthetic is placed between the rectus abdominis and the posterior rectus sheath or between the rectus abdominis and the transversus abdominis.5

Nerves involved4:• Dermatomes T6 to T10-T12

Subcostal TAP block

Classic TAP block

Important Safety Information (continued)Warnings and Precautions Specific to EXPAREL (continued)EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use.


Important Safety Information (continued)Warnings and Precautions Specific to EXPARELAvoid additional use of local anesthetics within 96 hours following administration of EXPAREL.

Suggested dose and volume range of EXPAREL for a classic TAP block• Example dosing and expansion ≥30 mL per side

Bilateral classic TAP block 20 mL of 266 mg EXPAREL + 20 mL of 0.25% bupivacaine + 20 mL of normal saline

60 mL total volume


Common applications/procedures for a subcostal TAP block• Upper abdominal surgeries (incisions above the

umbilicus)10

• Can be added to a classic TAP block for coverage above and below the umbilicus3

Suggested dose and volume range of EXPAREL for a subcostal TAP block• Example dosing and expansion ≥30 mL per side

Bilateral subcostal TAP block 20 mL of 266 mg EXPAREL + 20 mL of 0.25% bupivacaine + 20 mL of normal saline

60 mL total volume


— Laparoscopic cholecystectomy12

— Nephrectomy13

— Colorectal3

— Upper midline laparotomy4

— Laparoscopic/robotic surgery14

— Hysterectomy14

— Abdominalhysterectomy2

— Prostatectomy2

Med

ial

RA, rectus abdominis.

Superficial

Deep

RA

TA

Peritoneum

[5/Go 2016/p3/col2/par1/ln3-7]

[4/Niraj 2010/p11/col1/par5/ln2-5, 9-11]

[10/Webster 2010/p14/col1/par2/ln6-7][12/Chen 2013/p512/col1/par1/ln7-13][13/Harish 2009/p889/col2/par1/ln2-5][3/Borglum 2012/p75/par2/ln1-6][4/Niraj 2010/p10/col2/Fig2][14/Hutchins 2015/p612/col1/par3/all][14/Hutchins 2015/p612/col1/par3/all][3/Borglum 2012/p/p72/Table2/col2/row1]


6

Performing a bilateral 4-point TAP block in major abdominal surgeries

Performing a rectus sheath block in midline incisions

Med

ial

Superficial

Deep

Med

ial

Superficial

Deep

Common applications/procedures for a bilateral 4-point TAP block • Major abdominal surgeries (combination block

anesthetizes entire abdominal wall) — Laparoscopy15

— Laparotomy15

— Abdominal wall repair15

— Colorectal3

— Bariatric16

Administration of a bilateral 4-point TAP blockIn a 4-point TAP block, a local anesthetic is placed at the 4 injection sites used for a bilateral classic TAP block and subcostal TAP block.1

Nerves involved5:• Dermatomes T6 to T12

Administration of a rectus sheath blockIn a rectus sheath block, a local anesthetic is placed in the posterior border of the rectus abdominis muscle and the rectus sheath.17




Important Safety Information (continued)Warnings and Precautions for Bupivacaine-Containing Products (continued)Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias, sometimes leading to death.

Important Safety Information (continued)Warnings and Precautions for Bupivacaine-Containing ProductsCentral 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.

Suggested dose and volume range of EXPAREL for a 4-point TAP block• Example dosing and expansion ≥20 mL per side

Bilateral 4-point TAP block 20 mL of 266 mg EXPAREL + 40 mL of 0.25% bupivacaine + 20 mL of normal saline

80 mL total volume

Inject 20 mL per site.

Lateral

RARA

Peritoneum

Rectus sheath

EO

IO

TA

Peritoneum

[1/Gadsden 2015/p115/col1/par1/ln12-15]

[5/Go 2016/p11/Table1/row6]

[15/Borglum 2011/p659/col1/par2/ln9-12][15/Borglum 2011/p659/col1/par2/ln9-12][15/Borglum 2011/p659/col1/par2/ln9-12][3/Borglum 2012/p75/par2/ln1-6][16/Bhakta/p644/col2/par4/ln1-9/Table3, p645/Table4]

[15/Borglum 2011/p661/col2/par2/ln1-3]

7


Performing a bilateral 4-point TAP block in major abdominal surgeries

Performing a rectus sheath block in midline incisions

Med

ial

Superficial

Deep

Common applications/procedures for a bilateral 4-point TAP block • Major abdominal surgeries (combination block

anesthetizes entire abdominal wall) — Laparoscopy15

— Laparotomy15

— Abdominal wall repair15

— Colorectal3

— Bariatric16

Common applications/procedures for a rectus sheath block• Midline incisions, including17

— Umbilical hernia repairs — Incisional hernia repairs

Administration of a rectus sheath blockIn a rectus sheath block, a local anesthetic is placed in the posterior border of the rectus abdominis muscle and the rectus sheath.17




Rectus sheathblock

Important Safety Information (continued)Warnings and Precautions for Bupivacaine-Containing Products (continued)Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias, sometimes leading to death.

Important Safety Information (continued)Warnings and Precautions for Bupivacaine-Containing ProductsCentral 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.

Suggested dose and volume range of EXPAREL for a 4-point TAP block• Example dosing and expansion ≥20 mL per side

Bilateral 4-point TAP block 20 mL of 266 mg EXPAREL + 40 mL of 0.25% bupivacaine + 20 mL of normal saline

80 mL total volume

Inject 20 mL per site.

Suggested dose and volume range of EXPAREL for a rectus sheath block• Example dosing and expansion ≥20 mL per side

Bilateral rectus sheath block 20 mL of 266 mg EXPAREL + 20 mL of 0.25% bupivacaine

40 mL total volume


Lateral

RA

Peritoneum

Rectus sheath

[17/Yarwood 2010/p183/col2/par7/ln1,2,p184/col1/par1/ln1,2]

[5/Go 2016/p2/col1/par2/ln23-29]

[17/Yarwood 2010/p183/col2/par5/ln4-5]


8

Performing a QL block in more extensive abdominal surgeries

Performing TAP blocks in abdominal laparoscopic procedures

Administration of a QL block In a QL block, a local anesthetic may be placed posterior to the QL, between the psoas muscle and the QL muscle, or at the junction of the external oblique and internal oblique aponeurosis and the QL.5

Nerves involved6:• Dermatomes T4 to L1

Administration of a laparoscopic TAP block Laparoscopic TAP blocks are administered under direct vision, internally.19

Med

ial Lateral

QLblock

Important Safety Information (continued)Warnings and Precautions for Bupivacaine-Containing Products (continued)Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.


Important Safety Information (continued)Warnings and Precautions for Bupivacaine-Containing Products (continued)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.

Suggested dose and volume range of EXPAREL for a QL block• Example dosing and expansion ≥25 mL per side

Bilateral QL block 20 mL of 266 mg EXPAREL + 20 mL of 0.25% bupivacaine + 10 to 20 mL of normal saline

50 to 60 mL total volume

Inject 25 to 30 mL per side.

Images courtesy of Deborah Keller, MD.

Watch Dr Jacob Hutchins performing an abdominal field block with EXPAREL

Deep

Superficial

Common applications/procedures for a QL block• QL blocks have been used in procedures requiring

more extensive abdominal-wall coverage, including3,18

— Exploratory laparotomy, large-bowel resection, ileostomy, open or laparoscopic appendectomy, cholecystectomy

— Cesarean delivery, total abdominal hysterectomy — Open prostatectomy, renal transplant surgery,

nephrectomy

Peritoneum

EO

IO

TA

[5/Go 2016/p6/col1/par2/ln14-21]

[6/NYSORA/p1/para1/ln11-13]

[3/Borglum 2012/p82/par1/ln1-4][17/Eisharkawy 2015/p2/Indications/par1/ln1,2/bullets 1-3]

9


Performing a QL block in more extensive abdominal surgeries

Performing TAP blocks in abdominal laparoscopic procedures

Administration of a laparoscopic TAP block Laparoscopic TAP blocks are administered under direct vision, internally.19

View from the laparoscopic camera directed at the anterolateral abdominal wall19

Internal bulge reflecting visible local anesthetic infiltration into the TAP block19

• Example dosing and expansion range ≥30 mL per side

Bilateral laparoscopic TAP block 20 mL of 266 mg EXPAREL + 20 mL of 0.25% bupivacaine + 20 mL of normal saline

60 mL total volume


QLblock

Important Safety Information (continued)Warnings and Precautions for Bupivacaine-Containing Products (continued)Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.


Important Safety Information (continued)Warnings and Precautions for Bupivacaine-Containing Products (continued)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.

Suggested dose and volume range of EXPAREL for a QL block• Example dosing and expansion ≥25 mL per side

Bilateral QL block 20 mL of 266 mg EXPAREL + 20 mL of 0.25% bupivacaine + 10 to 20 mL of normal saline

50 to 60 mL total volume

Inject 25 to 30 mL per side.

Images courtesy of Deborah Keller, MD.

Watch Dr Jacob Hutchins performing an abdominal field block with EXPAREL

Common applications/procedures for a QL block• QL blocks have been used in procedures requiring

more extensive abdominal-wall coverage, including3,18

— Exploratory laparotomy, large-bowel resection, ileostomy, open or laparoscopic appendectomy, cholecystectomy

— Cesarean delivery, total abdominal hysterectomy — Open prostatectomy, renal transplant surgery,

nephrectomy

[19/Chetwood 2011/p317/col2/par3/ln12-15]

[19/Chetwood 2011/p317/Fig1]

[19/Chetwood 2011/p317/Fig2]

10

Dosing considerations • Size of the surgical site• Volume needed to cover the width and depth of site• Patient factors that could impact safety of an

amide local anesthetic

• Maximum dose should not exceed 266 mg (20 mL)• Intended for single-dose administration only

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, ensuringlong-lasting analgesia

• TAP blocks require large volumes of local anesthetic to obtain reliable blockade

• For large surgical sites, the 266 mg (20 mL) vial of EXPAREL can be expanded with normal saline or lactated Ringer’s solution up to a total volume of 300 mL

Procedure Incisions Expanded volume

Open hysterectomy Intraumbilical midline incision T10 to L1 60 mL (TAP)

Small-bowel resection with primary anastomosis, ileostomy takedown, and removal of left subfascial port

Laparoscopic ports 60 mL (20 mL infiltration; 40 mL TAP)

Open abdominal-wall reconstruction

25-cm inverted-T incision with resection of skin and soft tissue

150 mL (50 mL infiltration; 100 mL field block)

Laparoscopic sleeve gastrectomy 2-cm incision in right midabdomen (15-mm trocar); 1.2-cm incision 8 cm above the umbilicus in the midline (10-mm trocar for camera); 0.7-cm incisions in left upper quadrant (5-mm trocar) in subxiphoid space (liver retractor) and in left lower quadrant (5-mm trocar)

220 mL (≈60 mL infiltration; ≈160 mL TAP)

Example expansion volumes are based on case reports that represent the individual experience of clinicians, and are intended to demonstrate their methodology for using EXPAREL in specifi c soft-tissue procedures. Pacira BioSciences, Inc. recognizes that there are alternative methodologies for administering local anesthetics, as well as individual patient considerations, when selecting the dose for a specifi c procedure.

Examples of expansion volumes by TAP procedure

Important Safety Information (continued)EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

Image used with permission from Je� rey Gadsden, MD.

Dosing and administration information for EXPAREL

[PI/p2/section 2.2/¶1/bullets 1-3]

[PI/p2/section 1/¶1]

[PI/p2/section2.1/bullet4]

[20/Lee 2015/p2/col1/Figure 1]

[PI/p2/Sec2.2/bullet1]

[PI/p2/Sec2.2/bullet2,p19/Sec11/par1/ln3-4][PI/p19/Sec11/par1/ln3-4]

Data supported as extrapolation of PI,per Medical Reviewer


11

OR

EXPAREL266 mg(20 mL)

+ Up to 30 mL of 0.5% bupivacaine HCl

150 mg total

30mL

Bupivacaine HCI0.5%

+ Up to 60 mL of 0.25% bupivacaine HCl

150 mg total

60mL

Bupivacaine HCI0.25%

• Admixing may impact the pharmacokinetic/pharmacodynamic properties of EXPAREL; the effect is concentration dependent

For early analgesic coverage, administer with bupivacaine HCl • 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 the 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

Example of admixing

Important Safety Information (continued)Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation.



[PI/p3/Sec2.4/bullet2,p4/par1]

[PI/p2/Sec2.2/par1/ln1-2,p4/Sec3/bullet1]Data supported as extrapolation of PI, per Medical Reviewer.


[PI/p1/col2/Drug Interactions/bullet2,p3/Sec2.4/bullet2]

EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

Please see Important Safety Information throughout and refer to accompanying full Prescribing Information.

THE USE OF EXPAREL IN ABDOMINAL-WALL FIELD BLOCKS

IndicationEXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia.





Warnings and Precautions Specific to EXPARELAvoid 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, or intravascular or intra-articular use.


Warnings and Precautions for Bupivacaine-Containing ProductsCentral 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.


6 millionpatients have received non-opioid EXPAREL

since 201220

Visit www.EXPAREL.com to learn more.

Please refer to accompanying full Prescribing Information.For more information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727).References: 1. Gadsden J, Ayad S, Gonzales JJ, Mehta J, Boublik J, Hutchins J. Evolution of transversus abdominis plane infi ltration techniques for postsurgical analgesia following abdominal surgeries. Local Reg Anesth. 2015;8:113-117. 2. Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi:10.1155/2012/731645. 3. Børglum J, Jensen K. Abdominal surgery: advances in the use of ultrasound-guided truncal blocks for perioperative pain management. In: Derbel F, ed. Abdominal Surgery. Rijeka, Croatia: InTech; 2012:69-94. 4. Niraj G, Kelkar A, Powell R. Ultrasound-guided subcostal transversus abdominis plane block. International Journal of Ultrasound and Applied Technologies in Perioperative Care. 2010;1(1):9-12. 5. Go R, Huang YY, Weyker PD, Webb CA. Truncal blocks for perioperative pain management: a review of the literature and evolving techniques. Pain Manag. 2016;6(5):455-468. 6. Ultrasound-guided transversus abdominis plane and quadratus lumborum blocks. New York School of Regional Anesthesia website. https://www.nysora.com/regional-anesthesia-for-specifi c-surgical-procedures/abdomen/ultrasound-guided-transversus-abdominis-plane-quadratus-lumborum-blocks. Accessed April 23, 2019. 7. Detton AJ. Grant’s Dissector. 16th ed. Philadelphia, PA: Wolters Kluwer; 2017:109. 8. Rafi AN. Abdominal fi eld block: a new approach via the lumbar triangle. Anaesthesia. 2001;56(10):1024-1026. 9. McDonnell JG, O’Donnell BD, Farell T, et al. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007;32(5):399-404. 10. Webster K. Ultrasound guided rectus sheath block-analgesia for abdominal surgery. Update Anaesth. 2010;26:12-17. 11. Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013;27(7):2481-2486. 12. Chen CK, Tan PC, Phui VE, Teo SC. A comparison of analgesic e� cacy between oblique subcostal transversus abdominis plane block and intravenous morphine for laparoscopic cholecystectomy. A prospective randomized controlled trial. Korean J Anesthesiol. 2013;64(6):511-516. 13. Harish R. Low-dose infusion with “surgical transverse abdominis plane (TAP) block” in open nephrectomy. Br J Anaesth. 2009;102(6):889-890. 14. Hutchins J, Delaney D, Vogel RI, et al. Ultrasound guided subcostal transversus abdominis plane (TAP) infi ltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: a prospective randomized controlled study. Gynecol Oncol. 2015;138(3):609-613. 15. Børglum J, Maschmann C, Belhage B, Jensen K. Ultrasound-guided bilateral dual transversus abdominis plane block: a new four-point approach. Acta Anaesthesiol Scand. 2011;55(6):658-663. 16. Bhakta A, Glotzer O, Ata A, Tafen M, Stain S, Singh P. Analgesic e� cacy of laparoscopic guided transverse abdominis plane block using liposomal bupivacaine in bariatric surgery. Am J Surg. 2018;215(4):643-646. 17. Yarwood J, Berrill A. Nerve blocks of the anterior abdominal wall. Cont Educ Anaesth Crit Care Pain. 2010;10(6):182-186. 18. Elsharkawy H. Ultrasound-guided quadratus lumborum block: how do I do it? American Society of Regional Anesthesia and Pain Medicine website. https://www.asra.com/pain-resource/article/48/ultrasound-guided-quadratus-lumborum-blo. Accessed April 1, 2019. 19. Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011;66(4):317-318. 20. Data on fi le. 5903. Parsippany, NJ: Pacira BioSciences, Inc.; October 2019.

©2019 Pacira BioSciences, Inc.Parsippany, NJ 07054 PP-EX-US-4903 11/19

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