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neffy combines 3 proven FDA-approved components6

Image of neffy® (epinephrine nasal spray), including a callout of it not being the actual product size

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FDA, US Food and Drug Administration; Rx, prescription.

References: 1. neffy [prescribing information]. San Diego, CA: ARS Pharmaceuticals Operations, Inc.
2. Data on file. EPI-15 CSR. ARS Pharmaceuticals Operations, Inc. 2024. 3. Data on file. EPI-16 CSR. ARS Pharmaceuticals Operations, Inc. 2022. 4. Data on file. Human Factors Study. ARS Pharmaceuticals Operations, Inc. 2024. 5. Casale TB, Lockey R, Portnoy J, et al. Presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting; February 24, 2023; San Antonio, TX. 6. Ellis AK, Casale TB, Kaliner M, et al. Development of neffy, an epinephrine nasal spray, for severe allergic reactions. Pharmaceutics. 2024;16(6):811. 7. Rabinowicz AL, Carrazana E, Maggio ET. Improvement of intranasal drug delivery with Intravail® alkylsaccharide excipient as a mucosal absorption enhancer aiding in the treatment of conditions of the central nervous system. Drugs R D. 2021:21(4):361-369.

INDICATION AND IMPORTANT SAFETY INFORMATION

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INDICATION

neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 15 kg or greater.

IMPORTANT SAFETY INFORMATION

It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose.

neffy is for use in the nose only.

Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.

Absorption of neffy may be affected by underlying structural or anatomical nasal conditions.

Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.

The presence of a sulfite in neffy should not deter use.

neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy.

Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions.

Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.

Most common adverse reactions are nasal discomfort, headache, rhinorrhea, dizziness, nausea, vomiting, throat irritation, nasal congestion, paresthesia, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery.

These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at. 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for neffy.