Standard Dose of Neffy for Anaphylaxis Treatment
For patients aged ≥4 years and weighing ≥15 kg who would otherwise be prescribed an EpiPen, the standard dose of Neffy (intranasal epinephrine) is 2 mg administered as a single spray into one nostril. 1
Dosing Algorithm by Weight
Weight-based dosing for Neffy follows this straightforward approach:
- Patients weighing ≥30 kg: Neffy 2 mg (single spray into one nostril) 1
- Patients weighing 15 to <30 kg: Neffy 1 mg (single spray into one nostril) 1
- Patients weighing <15 kg: Neffy is not approved for this weight range 1
This dosing mirrors the traditional EpiPen approach where patients ≥30 kg typically receive 0.3 mg intramuscular epinephrine, while those 15-30 kg receive 0.15 mg. 2
Pharmacokinetic Justification
The 2 mg intranasal dose achieves plasma epinephrine levels bracketed by approved injection products. Neffy 2 mg produces a mean peak plasma concentration of 481 pg/mL in adults, which falls between EpiPen 0.3 mg (753 pg/mL) and manual intramuscular injection 0.3 mg (339 pg/mL). 3 In pediatric patients weighing ≥30 kg, Neffy 2 mg resulted in a mean maximum concentration of 690 pg/mL, while the 1 mg dose in patients 15-<30 kg achieved 651 pg/mL—both within the expected safe and efficacious range. 4
Pharmacodynamic responses with Neffy are comparable to or exceed those of intramuscular epinephrine. The median systolic blood pressure and pulse rate responses following Neffy administration demonstrate appropriate cardiovascular effects consistent with effective epinephrine delivery. 1, 3
Repeat Dosing Considerations
A second dose may be administered 10 minutes after the first dose if symptoms persist or worsen. 1 When two doses are needed, they can be administered into either the same nostril or opposite nostrils with similar systemic exposure. 1 This is consistent with traditional epinephrine autoinjector guidance, where 18-35% of anaphylaxis cases may require a second dose. 2
Clinical Efficacy Evidence
Neffy successfully treated oral food challenge-induced anaphylaxis symptoms in pediatric patients. In a Phase 3 study of 15 pediatric patients aged 6-17 years, all patients who received weight-appropriate Neffy dosing (1 mg for 15-<30 kg, 2 mg for ≥30 kg) experienced symptom resolution with a median time of 16 minutes, and no patients required a second dose for the initial reaction. 5
Important Caveats
Neffy is NOT a substitute for emergency medical care. Patients should still activate emergency medical services (EMS) after administration, as with any epinephrine product. 1, 6 The most common adverse reactions include nasal discomfort (10-19%), headache (6-18%), and throat irritation (2-19%), which are generally mild and self-limiting. 1
Nasal congestion does not significantly impair Neffy absorption. Studies using nasal allergen challenge to induce rhinitis demonstrated that Neffy maintains adequate systemic exposure and pharmacodynamic responses even in the presence of nasal congestion. 1