Label: PAVBLU- aflibercept-ayyh injection, solution

  • NDC Code(s): 55513-056-01, 55513-065-01
  • Packager: Amgen, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated October 28, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use PAVBLU safely and effectively. See full prescribing information for PAVBLU. PAVBLU™ (aflibercept-ayyh) injection, for intravitreal ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    PAVBLU is indicated for the treatment of: 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD)   1.2 Macular Edema Following Retinal Vein Occlusion (RVO)   1.3 Diabetic Macular ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Injection Instructions - For ophthalmic intravitreal injection. PAVBLU must only be administered by a qualified physician. Prefilled Syringe: A 30-gauge × ½-inch sterile injection ...
  • 3 DOSAGE FORMS AND STRENGTHS
    PAVBLU is a clear to opalescent and colorless to slightly yellow solution available as: Injection: 2 mg (0.05 mL of 40 mg/mL solution) in a single-dose prefilled plastic syringe - Injection: 2 mg ...
  • 4 CONTRAINDICATIONS
    4.1 Ocular or Periocular Infections - PAVBLU is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation - PAVBLU is contraindicated in patients ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Endophthalmitis, Retinal Detachments, and Retinal Vasculitis with or without Occlusion - Intravitreal injections, including those with aflibercept products, have been associated with ...
  • 6. ADVERSE REACTIONS
    The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3)] Endophthalmitis, retinal detachments, and Retinal ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Adequate and well-controlled studies with aflibercept have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits ...
  • 10 OVERDOSAGE
    Overdosing with increased injection volume may increase intraocular pressure. Therefore, in case of overdosage, intraocular pressure should be monitored and if deemed necessary by the treating ...
  • 11 DESCRIPTION
    Aflibercept-ayyh is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No studies have been conducted on the mutagenic or carcinogenic potential of aflibercept products. Effects on male and female fertility ...
  • 14 CLINICAL STUDIES
    14.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) The safety and efficacy of aflibercept were assessed in two randomized, multi-center, double-masked, active-controlled studies in ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Each prefilled syringe or vial is for single eye use only. Discard unused portion. PAVBLU injection is a clear to opalescent and colorless to slightly yellow solution supplied ...
  • 17 PATIENT COUNSELING INFORMATION
    In the days following PAVBLU administration, patients are at risk of developing endophthalmitis, retinal detachment, or retinal vasculitis with or without occlusion. If the eye becomes red ...
  • SPL UNCLASSIFIED SECTION
    PAVBLU™ (aflibercept-ayyh) Manufactured by: Amgen, Inc. One Amgen Center Drive - Thousand Oaks, CA 91320-1799 - U.S. License Number 1080 - AMGEN® and PAVBLU™ (aflibercept-ayyh) are trademarks owned ...
  • PRINCIPAL DISPLAY PANEL - 0.05 mL Syringe Carton
    2 mg / 0.05 mL - PAVBLU™ (aflibercept-ayyh) Injection - NDC 55513-056-96 - Not for Sale - 2 mg (0.05 mL of 40 mg/mL solution) Carton contents: one blister pack containing one sterile, single-dose ...
  • PRINCIPAL DISPLAY PANEL - 0.05 mL Vial Carton
    2 mg / 0.05 mL - NDC 55513-065-01 - PAVBLU™ (aflibercept-ayyh) Injection - 2 mg (0.05 mL of - 40 mg/mL solution) For Intravitreal Injection - One Single-Dose Vial - Sterile Solution - Contains no ...
  • INGREDIENTS AND APPEARANCE
    Product Information