Label: OMEGAVEN- fish oil injection, emulsion

  • NDC Code(s): 63323-205-00, 63323-205-21, 63323-205-31, 63323-205-50
  • Packager: Fresenius Kabi USA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 19, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use OMEGAVEN safely and effectively. See full prescribing information for OMEGAVEN. OMEGAVEN (fish oil triglycerides) injectable ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Limitations of Use: Omegaven is not indicated for ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Administration Instructions - Omegaven can be administered alone or as part of a PN admixture. Omegaven is for central or peripheral intravenous infusion. When administered with ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injectable Emulsion: 5 g/50 mL and 10 g/100 mL (0.1 g/mL) sterile, white, homogenous emulsion in a 50-mL and 100-mL single-dose bottle.
  • 4 CONTRAINDICATIONS
    Use of Omegaven is contraindicated in patients with: Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients [see Warnings and Precautions (5.2)]. Severe ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants - In the postmarket setting, serious adverse reactions including acute respiratory ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants ...
  • 7 DRUG INTERACTIONS
    7.1 Antiplatelet Agents and Anticoagulants - Some published studies have demonstrated prolongation of bleeding time in patients taking antiplatelet agents or anticoagulants and oral omega-3 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no available data on Omegaven use in pregnant women to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or ...
  • 10 OVERDOSAGE
    In the event of an overdose, serious adverse reactions may occur [see Warnings and Precautions (5.1, 5.4)]. Stop the infusion of Omegaven until triglyceride levels have normalized and any symptoms ...
  • 11 DESCRIPTION
    Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Omegaven provides a biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an important substrate for energy production. The most ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No studies have been performed with fish oil triglycerides to evaluate the carcinogenic potential or its effect on fertility. Fish ...
  • 14 CLINICAL STUDIES
    The efficacy of Omegaven was evaluated in two open-label single-center clinical trials (Study 1, NCT00910104, and Study 2, NCT00738101) in pediatric patients with PNAC (defined as direct or ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Omegaven (fish oil triglycerides) injectable emulsion, 5 g/50 mL and 10 g/100 mL (0.1 g/mL) is a white, homogenous, sterile emulsion supplied as follows: 50 mL single-dose glass bottle - NDC ...
  • 17 PATIENT COUNSELING INFORMATION
    When initiating Omegaven administration, discuss the following information: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants - Inform ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Label - NDC 63323-205-21 255050 - Omegaven - ® (fish oil triglycerides) Injectable emulsion - 5 grams per 50 mL - (0.1 grams per ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Carton Label - NDC 63323-205-50 255050 - Omegaven - ® (fish oil triglycerides) Injectable emulsion - 5 grams per 50 mL - (0.1 grams per ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Label - NDC 63323-205-31 255100 - Omegaven - ® (fish oil triglycerides) Injectable emulsion - 10 grams per 100 mL - (0.1 grams per ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Carton Label - NDC 63323-205-00 255100 - Omegaven - ® (fish oil triglycerides) Injectable emulsion - 10 grams per 100 mL - (0.1 grams per ...
  • INGREDIENTS AND APPEARANCE
    Product Information