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NEW XARACOLL® (bupivacaine HCl) implant

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Indications and Usage

XARACOLL is indicated in adults for placement into the surgical site to produce postsurgical local analgesia for up to 24 hours following open inguinal hernia repair.

Limitations of Use

Safety and effectiveness have not been established in other surgical procedures, including orthopedic and boney procedures.

Important Safety Information

CONTRAINDICATIONS

  • Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of XARACOLL
  • Obstetrical paracervical block anesthesia. The use of bupivacaine in this technique has resulted in fetal bradycardia and death

WARNINGS AND PRECAUTIONS

  • Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after placement of XARACOLL
  • Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. See full Prescribing Information for more detail on managing these risks

ADVERSE REACTIONS

Most common adverse reactions in clinical trials (incidence ≥2% and higher than placebo) included incision site swelling, dysgeusia, headache, tremor, blurred vision, seroma, scrotal swelling, pyrexia, oral hypoaesthesia, and post procedural discharge.

To report SUSPECTED ADVERSE REACTIONS, contact Innocoll at 1-833-606-1421 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Local Anesthetics: The toxic effects of local anesthetics are additive. Avoid additional local anesthetic administration within 96 hours following XARACOLL implantation. If additional local anesthetic administration with XARACOLL cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Based on animal data, may cause fetal harm
  • Moderate to Severe Hepatic Impairment: Consider increased monitoring for bupivacaine systemic toxicity

Please see full Prescribing Information.

References

1. Data on File. Innocoll Pharmaceuticals Limited. 2. Leiman D, Niebler G, Minkowitz H. Pharmacokinetics and safety of the bupivacaine collagen-matrix implant (INL-001) compared to liquid bupivacaine infiltration after open inguinal hernia repair. Poster presented at: World Congress on Regional Anesthesia & Pain Medicine; April 19-21, 2018; New York, NY. Accessed July 30, 2020. https://epostersonline.com/ASRAWORLD18/node/1154 3. Velanovich V, Rider P, Deck K, et al. Safety and efficacy of bupivacaine HCl collagen-matrix implant (INL-001) in open inguinal hernia repair: results from two randomized controlled trials. Adv Ther. 2019;36:200-216.

XARACOLL is a registered trademark of Innocoll Pharmaceuticals Limited.

©2022 Innocoll Pharmaceuticals Limited. All rights reserved. XAR129 Last Updated 4/22

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To request XARACOLL Medical Information or to report a product complaint or Adverse Reaction to Innocoll:

1-833-606-1421 Email Us

To report a product complaint or Adverse Reaction to the FDA:

1-800-FDA-1088 www.fda.gov/medwatch
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