Label: NEFFY- epinephrine spray

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 3, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use NEFFY - ®safely and effectively. See full prescribing information for NEFFY - ®. NEFFY - ®(epinephrine nasal spray) Initial ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - The recommended dosage of neffy is one spray (2 mg of epinephrine) administered into one nostril. In the absence of clinical improvement or if symptoms worsen after the ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Nasal spray: 2 mg/0.1 mL of epinephrine per spray in a single-dose nasal spray.
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Potential Altered Absorption of Neffy in Patients with Underlying Structural or Anatomical Nasal Conditions - Clinical pharmacology studies with neffy included subjects with history of ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Use of Epinephrine in Certain Coexisting Conditions - [see ...
  • 7 DRUG INTERACTIONS
    7.1 Potential Increased Exposure of Nasal Spray Drugs - Neffy may alter nasal mucosa for up to 2 weeks after administration, and thus may increase systemic absorption of nasal products, including ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, have not identified a drug associated risk of ...
  • 10 OVERDOSAGE
    Overdosage of epinephrine has been reported to produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also ...
  • 11 DESCRIPTION
    Neffy contains epinephrine, a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-dihydroxy-α-[(methylamino)methyl] benzyl alcohol with molecular weight of 183.21 g/mol and the ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Epinephrine acts on both alpha and beta-adrenergic receptors. Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted. Epinephrine and other catecholamines ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Neffy (epinephrine nasal spray): 2 mg/0.1 mL of epinephrine is supplied in a carton containing two (2) blister packages each with a single-dose nasal spray product for 1 time use ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration - Neffy nasal spray is for single use and delivers the entire dose ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for ARS Pharmaceuticals Operations, Inc., 11682 El Camino Real, San Diego, CA 92130. Neffy is a registered trademark of ARS Pharmaceuticals Operations, Inc. Copyright ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - NEFFY - ®(ne'fee) (epinephrine nasal spray) For allergic emergencies (anaphylaxis) This Patient Information has been ...
  • PRINCIPAL DISPLAY PANEL - OUTER PACKAGE
    NDC 71872-7330-1 - Rx Only - neffy - ® (epinephrine nasal spray) 2 mg - For Use in the Nose Only (Single-dose) Read the Instructions for Use for complete - information on how to use ...
  • INGREDIENTS AND APPEARANCE
    Product Information