Label: EPTIFIBATIDE injection

  • NDC Code(s): 0338-9558-10
  • Packager: Baxter Healthcare Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 29, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use EPTIFIBATIDE INJECTION safely and effectively. See full prescribing information for EPTIFIBATIDE INJECTION. EPTIFIBATIDE injection ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Acute Coronary Syndrome (ACS) Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable ...
  • 2 DOSAGE AND ADMINISTRATION
    Eptifibatide injection in Galaxy container is for intravenous infusion only, not for intravenous bolus use. Before infusion of eptifibatide injection, the following laboratory tests should be ...
  • 3 DOSAGE FORMS AND STRENGTHS
    • Injection: 75 mg of eptifibatide per 100 mL (0.75 mg/mL) in a single-dose Galaxy container, for intravenous infusion only, not for intravenous bolus use
  • 4 CONTRAINDICATIONS
    Treatment with eptifibatide is contraindicated in patients with: • A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - • Severe hypertension ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Bleeding - Bleeding is the most common complication encountered during eptifibatide therapy. Administration of eptifibatide is associated with an increase in major and minor bleeding, as ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reaction is also discussed elsewhere in the labeling: • Bleeding [see Contraindications (4) and Warnings and Precautions (5.1)] 6.1 Clinical Trials ...
  • 7 DRUG INTERACTIONS
    7.1 Use of Thrombolytics, Anticoagulants, and Other Antiplatelet Agents - Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated ...
  • 10 OVERDOSAGE
    There has been only limited experience with overdosage of eptifibatide. There were 8 patients in the IMPACT II study, 9 patients in the PURSUIT study, and no patients in the ESPRIT study who ...
  • 11 DESCRIPTION
    Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive ligands to GP IIb/IIIa. When ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No long-term studies in animals have been performed to evaluate the carcinogenic potential of eptifibatide. Eptifibatide was not ...
  • 14 CLINICAL STUDIES
    Eptifibatide was studied in 3 placebo-controlled, randomized studies. PURSUIT evaluated patients with acute coronary syndromes: UA or NSTEMI. Two other studies, ESPRIT and IMPACT II, evaluated ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Eptifibatide injection is supplied as a refrigerated, premixed, sterile, non-pyrogenic solution in single-dose Galaxy containers packed in individual cartons. The single-dose ...
  • 17 PATIENT COUNSELING INFORMATION
    Instruct patients to inform the doctor or healthcare provider about any medical conditions, medications, and allergies.
  • SPL UNCLASSIFIED SECTION
    Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Logo - Baxter Healthcare Corporation - Deerfield, IL 60015 USA - 07-19-07-571 - Made in USA.
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL
    Container Label - NDC 0338-9558-10 - Eptifibatide Injection - 75 mg per 100 mL - (0.75 mg / mL) For Intravenous Infusion Only. Not for Intravenous Bolus Use. GALAXY - Single Dose ...
  • INGREDIENTS AND APPEARANCE
    Product Information