Children's Hospitals Today - Fall 2021 - 6

THE FIRST AND ONLY FDA-APPROVED
LONG-ACTING LOCAL ANALGESIC
FOR AGES 6 AND ABOVE1
Pediatric patients in the EXPAREL study
were defi ned as 6 to <17 years of age.
Indication
EXPAREL is indicated for single-dose infi ltration in patients
aged 6 years and older to produce postsurgical local
analgesia and in adults as an interscalene brachial plexus
nerve block to produce postsurgical regional analgesia. Safety
and effi cacy 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 infi ltration were nausea, constipation,
and vomiting; adverse reactions reported in adults with an
incidence greater than or equal to 10% following EXPAREL
administration via interscalene brachial plexus nerve block
were nausea, pyrexia, and constipation.
Adverse reactions with an incidence greater than or equal
to 10% following EXPAREL administration via infi ltration
in pediatric patients six to less than 17 years of age were
nausea, vomiting, constipation, hypotension, anemia, muscle
twitching, vision blurred, pruritus, and tachycardia.
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 populations: patients <6 years old for infi ltration,
patients younger than 18 years old for interscalene brachial
plexus nerve block, 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 Specifi c 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, or
intravascular or intra-articular use.
©2021 Pacira BioSciences, Inc. Parsippany, NJ 07054 PP-EX-US-6847 06/21
LEARN MORE AT
EXPAREL.com/pediatrics
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 brief summary of Prescribing Information on
adjacent page.
For more information, please visit www.EXPAREL.com or call
1-855-793-9727.
Reference: 1. Pacira BioSciences. Pacira BioSciences announces FDA
acceptance of sNDA for EXPAREL use in pediatric patients [press release].
Pacira website. https://investor.pacira.com/news-releases/news-releasedetails/pacira-biosciences-announces-fda-acceptance-snda-exparel-use.
Published
August 4, 2020. Accessed March 8, 2021.
Scan the QR code to see the safety
data of the multicenter PLAY study
BIOSCIENCES , INC .

http://www.EXPAREL.com/pediatrics http://www.EXPAREL.com https://investor.pacira.com/news-releases/news-releasedetails/pacira-biosciences-announces-fda-acceptance-snda-exparel-use. https://investor.pacira.com/news-releases/news-releasedetails/pacira-biosciences-announces-fda-acceptance-snda-exparel-use.

Children's Hospitals Today - Fall 2021

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