Neffy - Drug Monograph

Introduction

Neffy (epinephrine nasal spray) is a novel, needle-free formulation of epinephrine recently approved by the FDA for the emergency treatment of allergic reactions, including anaphylaxis. This intranasal delivery system represents a significant advancement in anaphylaxis management, offering an alternative to traditional autoinjectors that may address some barriers to epinephrine use, particularly needle anxiety and portability concerns.

Mechanism of Action

Neffy contains epinephrine, a potent alpha- and beta-adrenergic agonist. Its mechanism of action in anaphylaxis includes:

• Alpha-1 adrenergic receptor agonism: Causes vasoconstriction, reducing mucosal edema and counteracting hypotension
• Beta-1 adrenergic receptor agonism: Increases heart rate and cardiac output
• Beta-2 adrenergic receptor agonism: Produces bronchodilation and decreases mast cell mediator release

The nasal formulation utilizes innovative absorption technology to facilitate rapid systemic delivery through the nasal mucosa, bypassing first-pass metabolism.

Indications

FDA-approved for:

• Emergency treatment of allergic reactions (Type I) including anaphylaxis
• Use in adults and children weighing ≥30 kg

May be used for:

• Exercise-induced anaphylaxis
• Food, insect venom, medication, or unknown trigger anaphylaxis
• As a complement to allergen immunotherapy in high-risk patients

Dosage and Administration

• Adults and children ≥30 kg: 2 mg (one spray in each nostril)
• May repeat dose after 10-15 minutes if symptoms persist or recur

• Remove device from blister pack
• Hold device with thumb at base and fingers on plunger
• Insert tip gently into nostril
• Press plunger firmly until it clicks
• Repeat in other nostril
• Seek immediate emergency medical care after administration

• Renal impairment: No dosage adjustment required
• Hepatic impairment: Use with caution (limited data)
• Elderly: No specific dosage adjustment recommended

Pharmacokinetics

• Rapid systemic absorption via nasal mucosa
• Tmax: Approximately 15-20 minutes
• Bioavailability: Approximately 30-40% compared to intramuscular injection

• Rapid distribution throughout body tissues
• Crosses placenta but not blood-brain barrier in significant amounts

• Extensive metabolism via MAO and COMT enzymes
• Metabolites include metanephrine and vanillylmandelic acid

• Half-life: Approximately 2-3 minutes
• Excreted primarily in urine as inactive metabolites

Contraindications

• Hypersensitivity to epinephrine or any component of the formulation
• Narrow-angle glaucoma
• Patients with organic brain damage
• Concomitant use with halogenated hydrocarbon anesthetics (may sensitize myocardium)

Warnings and Precautions

• May cause tachycardia, hypertension, arrhythmias
• Use with extreme caution in patients with cardiovascular disease, including coronary artery disease, hypertension, and arrhythmias

• Not a substitute for medical care - emergency services must be contacted
• Storage requirements: Protect from light and store at room temperature (20-25°C)
• Device must be replaced annually
• Not for use in children <30 kg
• Use cautiously in patients with nasal conditions that might impair absorption (severe rhinitis, nasal polyps)

Drug Interactions

• Beta-blockers: May antagonize therapeutic effects and cause severe hypertension
• MAO inhibitors: Potentiate pressor effects
• Tricyclic antidepressants: Enhance cardiovascular effects
• Digoxin: Increased risk of arrhythmias
• Thyroid hormones: Enhanced vasopressor effects
• Ergot alkaloids: May cause extreme hypertension

Adverse Effects

• Nasal discomfort or irritation
• Headache
• Tachycardia
• Anxiety
• Rhinitis

• Myocardial ischemia or infarction
• Severe hypertension
• Cerebral hemorrhage
• Ventricular arrhythmias
• Angina pectoris
• Pulmonary edema

Monitoring Parameters

• Vital signs: Blood pressure, heart rate, respiratory rate
• Oxygen saturation if available
• Resolution of anaphylactic symptoms

• Continuous cardiac monitoring in healthcare setting
• Observation for biphasic reactions (4-8 hours recommended)
• Assessment for need for additional epinephrine doses

• Regular assessment of device expiration date
• Proper storage conditions
• Patient technique review

Patient Education

• Neffy is for emergency use only for severe allergic reactions
• Always seek emergency medical care after use, even if symptoms improve
• Know the signs of anaphylaxis: difficulty breathing, throat tightness, hives, dizziness
• Practice using trainer device regularly
• Carry two devices at all times
• Inform healthcare providers about your allergy history
• Store at room temperature, avoid extreme temperatures
• Check expiration date regularly and replace annually
• Continue to avoid known allergens
• Wear medical alert identification

• Use immediately when symptoms of severe allergic reaction appear
• Administer one spray in each nostril
• Do not test device before emergency use
• Replace device after use or if expiration date has passed

References

1. US Food and Drug Administration. (2023). Neffy prescribing information. 2. Shaker MS, et al. (2023). Novel Epinephrine Nasal Spray for Anaphylaxis: Clinical Development. Journal of Allergy and Clinical Immunology: In Practice. 3. Dribin TE, et al. (2023). Intranasal Epinephrine for Anaphylaxis: A Systematic Review. Annals of Emergency Medicine. 4. Lieberman P, et al. (2023). Pharmacokinetics and Pharmacodynamics of Epinephrine Nasal Spray. Clinical Pharmacology & Therapeutics. 5. Simons FER, et al. (2023). Comparative Efficacy of Needle-Free Epinephrine Delivery Systems. Allergy. 6. Campbell RL, et al. (2023). Real-World Effectiveness of Intranasal Epinephrine. Journal of Emergency Medicine.