Product Dossier

NEFFY

Product Dossier for NEFFY (adrenaline (epinephrine), Seqirus). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

NEFFY is adrenaline (epinephrine) nasal spray that delivers 1 mg or 2 mg in one spray of 100 microlitres of solution. It is a ready-to-use, single-dose nasal spray that delivers its entire dose upon activation. The product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Emergency treatment of type I allergic reactions, including anaphylaxis, in adults and children aged 4 years and older and weighing 15 kg or greater.

Dosing overview

NEFFY should be administered at the first sign of a severe type I allergic reaction. Dosing is weight-based:

If there is no clinical improvement, or if deterioration occurs or symptoms reappear after 5 minutes following the initial treatment, a second dose should be administered using a new NEFFY nasal spray (ideally in the same nostril). It is recommended that patients should always carry two NEFFY nasal sprays in case of severe allergic reaction. More than two sequential doses of adrenaline should be administered under direct medical supervision.

Key safety warnings

Patients with concomitant asthma may be at increased risk of severe anaphylactic reaction. Caution should be taken when administering adrenaline to patients who have heart disease including patients with cardiac arrhythmias, coronary artery disease, or hypertension, as adrenaline may precipitate or aggravate angina, as well as produce ventricular arrhythmias. There is a risk of adverse reactions following adrenaline administration in patients with high intraocular pressure, severe renal impairment, prostatic adenoma leading to residual urine, hypercalcaemia, and hypokalaemia. Individuals with hyperthyroidism, cardiovascular disease, hypertension, or diabetes, elderly individuals, and pregnant women may be at greater risk of developing adverse reactions after adrenaline administration. Although NEFFY contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons, the presence of a sulfite in NEFFY should not deter administration of the drug for treatment of serious allergic reactions including anaphylaxis. Anaphylaxis is a life-threatening emergency and self-administration of adrenaline is not intended as a substitute for immediate medical care; the patient should be advised to seek emergency medical assistance immediately following administration of NEFFY.

Contraindications

No contraindications are listed.

PBS listing

This product is not listed on the PBS.

Regulatory history

NEFFY adrenaline (epinephrine) 1 mg and 2 mg nasal spray vials were first registered on the ARTG on 8 December 2025 under licence category RE (Restricted Export/Restricted use).