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Dosing for local infiltration

Dosing for local infiltration

For adults, a maximum dose of 266 mg (20 mL) is recommended, based on:

  • Size of the surgical site
  • Volume required to cover the area
  • Individual patient factors that may impact the safety of an amide local anesthetic

For pediatric patients aged 6 to less than 17 years, dosing is weight based: 4 mg/kg (up to a maximum of 266 mg)

Admixing bupivacaine HCl with 266 mg (20 mL) of EXPAREL

  • 20 mL vial contains 266 mg of EXPAREL, which is equivalent to 300 mg of bupivacaine HCl
  • 1:2 ratio allows 150 mg of bupivacaine HCl to 266 mg of EXPAREL
dosing 266

Clinical & economic outcomes

EXPAREL is a cost-effective option for postsurgical pain management both in the hospital and in outpatient settings

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

†Opioid consumption was noted and converted to MED per hour of hospital stay.1

‡All pain was measured with the visual analog scale.2,4

§Opioid consumption was measured using IV morphine equivalent (mg).3

¶Parenteral and oral opioid intake was converted into oral morphine equivalents (mg) using standardized calculations.4

Multimodal protocols and results

Multimodal approaches with or without ERAS protocols have demonstrated benefits in breast surgeries.

Protocol implementation can positively impact recovery4

  • 35% shorter LOS3
  • 71% decrease in opioid use4
  • No reported increase in pain or complications3
Microsurgical Breast Reconstruction

Study design5

Retrospective analysis comparing an ERP with PCA of ketorolac and an EXPAREL TAP block (n=42) with historical controls (n=49) in patients undergoing deep inferior epigastric perforator or free transversus rectus abdominis myocutaneous flap breast reconstruction.

Multimodal protocol

INTRAOPERATIVE

POSTSURGICAL

INTRAOPERATIVE

  • Bilateral TAP block with EXPAREL 266 mg/20 mL expanded with saline 180 mL
  • Acetaminophen intravenously
  • Ketorolac intravenously
  • General anesthesia

POSTSURGICAL

  • PACU
    • Ketorolac 15 mg intravenously every 6 hours for 3 days
    • No intravenous PCA
    • Provision of oral or intravenous opioids for breakthrough pain
  • POD 1
    • Ketorolac 15 mg orally as needed after intravenous regimen

Patients who received multimodal analgesia with EXPAREL

Fewer opioids used*†
  • 46.0 mg vs 70.5 mg (P=0.003)
Shorter LOS
  • 4.0 days vs 5.0 days (P<0.001)

*Opioid intake measured in MED (mg).

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

ERP, enhanced recovery pathway; LOS, length of stay; MED, morphine equivalent dosing; PACU, postanesthesia care unit; PCA, patient-controlled analgesia; POD, postoperative day; TAP, transversus abdominis plane.

Study design4

Retrospective study comparing the efficacy of EXPAREL as a TAP block and local infiltration as part of an ERAS pathway (n=49) with a historical cohort of patients who received traditional care after surgery (n=51).

Multimodal protocol

PREOPERATIVE

INTRAOPERATIVE

POSTSURGICAL

PREOPERATIVE

  • Celecoxib orally
  • Acetaminophen orally
  • Gabapentin orally

INTRAOPERATIVE

  • Bilateral TAP block and local infiltration with EXPAREL 266 mg/20 mL expanded with normal saline

POSTSURGICAL

  • Celecoxib and acetaminophen as needed; oral opioids as needed for rescue

Patients who received multimodal analgesia with EXPAREL

Fewer opioids used*†
  • 167.3 mg vs 574.3 mg (P<0.001)
Shorter LOS
  • 3.9 days vs 5.5 days (P<0.001)

*Opioid intake measured in MED (mg).

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

ERAS, enhanced recovery after surgery; LOS, length of stay; MED, morphine equivalent dosing; TAP, transversus abdominis plane.

Societies recommend opioid-minimizing pain management platforms

The Breast Reconstruction Advisory Group and ERAS Society support the use of opioid-minimizing pain management strategies

ERAS, enhanced recovery after surgery.

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. Motakef S, Wong WW, Ingargiola MJ, et al. Liposomal bupivacaine in implant-based breast reconstruction. Plast Reconstr Surg Glob Open. 2017;5(11):e1559.
  2. Butz DR, Shenaq DS, Rundell VL, et al. Postoperative pain and length of stay lowered by use of Exparel in immediate, implant-based breast reconstruction. Plast Reconstr Surg Glob Open. 2015;3(5):e391.
  3. Jablonka EM, Lamelas AM, Kim JN, et al. Transversus abdominis plane blocks with single-dose liposomal bupivacaine in conjunction with a nonnarcotic pain regimen help reduce length of stay following abdominally based microsurgical breast reconstruction. Plast Reconstr Surg. 2017;140(2):240-251.
  4. Batdorf NJ, Lemaine V, Lovely JK, et al. Enhanced recovery after surgery in microvascular breast reconstruction. J Plast Reconstr Aesthet Surg . 2015;68(3):395-402.
  5. Afonso A, Oskar S, Tan KS, et al. Is enhanced recovery the new standard of care in microsurgical breast reconstruction? Plast Reconstr Surg. 2017;139(5):1053-1061.
  6. Afonso A, Newman MI, Seeley N, et al. Multimodal analgesia in breast surgical procedures: technical and pharmacological considerations for liposomal bupivacaine use. Plast Reconstr Surg Glob Open. 2017;5(9):e1480.
  7. Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, et al; ERAS Society. Consensus review of optimal perioperative care in breast reconstruction: Enhanced Recovery After Surgery (ERAS) Society recommendations. Plast Reconstr Surg. 2017;139(5):1056e-1071e.
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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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