Label: ZYNRELEF- bupivacaine and meloxicam solution

  • NDC Code(s): 47426-301-02, 47426-301-04, 47426-301-06, 47426-302-02, view more
  • Packager: Heron Therapeutics, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 3, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ZYNRELEF® safely and effectively. See full prescribing information for ZYNRELEF. ZYNRELEF (bupivacaine and meloxicam ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)
    Cardiovascular Thrombotic Events - Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke ...

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    Cardiovascular Thrombotic Events

    • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)].
    • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].

    Gastrointestinal Bleeding, Ulceration, and Perforation

    • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)].
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  • 1 INDICATIONS AND USAGE
    ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: soft tissue surgical procedures - orthopedic surgical procedures - – foot and ankle procedures - – other ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Dosage and Administration Information - ADMINISTER ZYNRELEF VIA INSTILLATION ONLY. ZYNRELEF should not be administered via the following ...
  • 3 DOSAGE FORMS AND STRENGTHS
    ZYNRELEF (bupivacaine and meloxicam) extended-release solution is a sterile, clear, pale-yellow to yellow, viscous liquid in a single-dose vial containing 29.25 mg/mL bupivacaine and 0.88 mg/mL ...
  • 4 CONTRAINDICATIONS
    ZYNRELEF is contraindicated in: Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular (CV) Thrombotic Events with NSAID Use - Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions have been associated with bupivacaine HCl or meloxicam and are discussed in greater detail in other sections of the labeling: Cardiovascular System ...
  • 7 DRUG INTERACTIONS
    7.1 Bupivacaine Drug Interactions - In clinical studies, other local anesthetics (including ropivacaine and lidocaine) have been administered before, during, or after application of ZYNRELEF ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no available human data on use of ZYNRELEF in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse ...
  • 10 OVERDOSAGE
    No data are available with regard to overdose of ZYNRELEF. Findings related to the individual active substances are listed below. 10.1 Bupivacaine - Clinical Presentation - Acute emergencies ...
  • 11 DESCRIPTION
    ZYNRELEF (bupivacaine and meloxicam) extended-release solution, for soft tissue or periarticular instillation use, contains bupivacaine, an amide local anesthetic, and meloxicam, a nonsteroidal ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - ZYNRELEF is a fixed-dose combination of bupivacaine and meloxicam. Bupivacaine - Local anesthetics block the generation and the conduction of nerve impulses ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility - The maximum recommended human dose (MRHD) of ZYNRELEF is 400 mg and 12 mg of bupivacaine and meloxicam ...
  • 14 CLINICAL STUDIES
    The efficacy of ZYNRELEF was established in 3 double-blind, controlled studies in patients undergoing bunionectomy (Study 1), unilateral open inguinal herniorrhaphy (Study 2), and total knee ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution is a clear, pale-yellow to yellow viscous liquid available in 4 presentations. Each single-dose glass vial is filled with a solution ...
  • 17 PATIENT COUNSELING INFORMATION
    Cardiovascular Thrombotic Events - Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for: Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA, 92121, USA. Patent: https://www.herontx.com/patents/ ZYNRELEF® is a registered trademark of Heron ...
  • Instructions For Use
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use - 400 mg bupivacaine and 12 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg ...
  • Instructions For Use
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use - 300 mg bupivacaine and 9 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg ...
  • Instructions For Use
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use - 200 mg bupivacaine and 6 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam ...
  • Instructions For Use
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use - 60 mg bupivacaine and 1.8 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg ...
  • Instructions For Use
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use - 400 mg bupivacaine and 12 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg ...
  • Instructions For Use
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use - 300 mg bupivacaine and 9 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg ...
  • Instructions For Use
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use - 200 mg bupivacaine and 6 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam ...
  • Instructions For Use
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution, for instillation use - 60 mg bupivacaine and 1.8 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 14 mL
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution - 400 mg bupivacaine and 12 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam - Single-Dose Application - For ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 10.5 mL
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution - 300 mg bupivacaine and 9 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam - Single-Dose Application - For ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 7 mL
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution - 200 mg bupivacaine and 6 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam - Single-Dose Application - For ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 2.3 mL
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution - 60 mg bupivacaine and 1.8 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam - Single-Dose Application - For ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 14 mL - NDC 47426-501
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution - 400 mg bupivacaine and 12 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam - Single-Dose Application - For ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 10.5 mL - NDC 47426-502
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution - 300 mg bupivacaine and 9 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam - Single-Dose Application - For ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 7 mL - NDC 47426-503
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution - 200 mg bupivacaine and 6 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam - Single-Dose Application - For ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton - 2.3 mL - NDC 47426-504
    ZYNRELEF® (bupivacaine and meloxicam) extended-release solution - 60 mg bupivacaine and 1.8 mg meloxicam - Each mL contains 29.25 mg bupivacaine and 0.88 mg meloxicam - Single-Dose Application - For ...
  • INGREDIENTS AND APPEARANCE
    Product Information