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Neffy is the only needle-free epinephrine nasal spray for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs (15 kg) or greater.

Neffy is available in two strengths:

• 1 mg – for children 4 years and older weighing 15 kg to less than 30 kg (33-66 lbs)
• 2 mg – for adults and children weighing 30 kg (66 lbs) or more

Each carton contains 2 single-dose nasal spray devices.

Neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.

Neffy acts on certain receptors in the body called alpha- and beta-adrenergic receptors. This causes the blood vessels to narrow (which can increase blood pressure), opens the airways, and reduces swelling. Epinephrine also alleviates itching, hives, and angioedema, and may relieve gastrointestinal symptoms associated with anaphylaxis by relaxing smooth muscle of the stomach, intestine, uterus, and urinary bladder.

1. Remove Neffy from packaging – Pull open the packaging to remove the nasal spray device
2. Hold device correctly – Hold the device with your thumb on the bottom of the plunger and a finger on either side of the nozzle. Do not pull or push on the plunger. Do not test or prime (pre-spray). Each device has only 1 spray.
3. Insert into nostril – Insert the nozzle into a nostril until your fingers touch your nose. Keep the nozzle straight into the nose pointed toward your forehead. Do not point the nozzle to the nasal septum (wall between nostrils) or outer wall of the nose.
4. Administer the dose – Press plunger up firmly until it snaps up and sprays liquid into the nostril. Do not sniff during or after the dose is given.
5. Second dose if needed – If symptoms continue or get worse after the first dose, administer a second dose using a new Neffy in the same nostril starting 5 minutes after the first dose.
6. Seek emergency care – Get emergency medical help for further treatment after using Neffy.

Always carry two Neffy nasal sprays with you because you may not know when anaphylaxis may happen.

Tell your healthcare provider about all your medical conditions, especially if you have:

• Heart problems
• Kidney problems
• Low potassium in your blood
• Parkinson’s disease
• Thyroid problems
• High blood pressure
• Diabetes
• Underlying structural or anatomical nasal conditions (nasal polyps, history of broken nose, nasal surgery)

Neffy hasn’t been studied in people with certain nasal conditions or a history of nasal trauma. It’s unclear how well the medication works in these situations, and it might not be absorbed correctly.

• Nasal discomfort
• Headache
• Throat irritation
• Chest and nasal congestion
• Feeling overly excited, nervous, or anxious
• Nose bleed
• Nose pain
• Sneezing
• Runny nose
• Dry nose or throat
• Tingling sensation (including in the nose)
• Feeling tired
• Dizziness
• Nausea and vomiting

Neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects.

Serious side effects to watch for include:

• Eye symptoms: Sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, seeing halos around lights
• Heart symptoms: Fast, irregular, or pounding heartbeats; fluttering in chest; shortness of breath; sudden dizziness, lightheadedness, or passing out
• Neurological symptoms: Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady
• Other serious effects: Very stiff muscles, high fever, profuse sweating, tremors
• Cardiovascular effects: Angina, arrhythmias (including fatal ventricular fibrillation), cerebral hemorrhage, hypertension, palpitations, tachycardia, stress cardiomyopathy

Drugs that may increase Neffy’s effects:

• Tricyclic antidepressants
• Monoamine oxidase inhibitors (MAOIs)
• Levothyroxine sodium (thyroid medication)
• Certain antihistamines (chlorpheniramine, tripelennamine, diphenhydramine)
• COMT inhibitors (such as entacapone for Parkinson’s disease)

Drugs that may reduce Neffy’s effects:

• Beta-adrenergic blocking drugs (such as propranolol)

Drugs requiring careful monitoring:

• Cardiac glycosides
• Diuretics (water pills)
• Anti-arrhythmic drugs
• Other nasal sprays (Neffy may alter nasal mucosa for up to 2 weeks, increasing absorption of other nasal products)

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It is not known if or how Neffy could affect pregnancy or harm an unborn baby. However, during pregnancy, anaphylaxis can be catastrophic and can lead to severe complications including permanent damage or death to both mother and fetus.

Doctors consider epinephrine an acceptable treatment for severe allergic reactions during pregnancy. The benefits of epinephrine treatment typically outweigh any risks. If you are pregnant and having a severe allergic reaction, you should use Neffy and get emergency help right away.

Breastfeeding: There are no data on the presence of epinephrine in human milk. However, due to its poor oral bioavailability and short half-life, transfer of epinephrine into breastmilk is expected to be low. Treatment for anaphylaxis in breastfeeding patients should not be delayed.

• Epinephrine