Neffy

Emergency Treatment of Allergic Reactions

Neffy is prescribed for the immediate treatment of severe, life-threatening allergic reactions (Type I). These reactions can occur quickly after exposure to an allergen and require urgent medical attention. It is intended for use in adults and children who weigh at least 30 kilograms (approximately 66 pounds).

Common Triggers

This medication is used to treat reactions caused by various triggers, including:

• Foods: Such as peanuts, tree nuts, shellfish, or dairy.
• Insect stings or bites: From bees, wasps, hornets, or fire ants.
• Medications: Reactions to certain drugs or vaccines.
• Other substances: Such as latex or other environmental allergens.
• Exercise: For individuals who experience exercise-induced anaphylaxis.

Neffy is designed for emergency use by the patient, a caregiver, or a bystander when a severe reaction begins. It provides a needle-free alternative to traditional epinephrine injections.

Mechanism of Action

Neffy contains epinephrine, a medication that acts as a sympathomimetic agent. This means it mimics the effects of naturally occurring chemicals in the body that respond to stress or danger. When administered during a severe allergic reaction (anaphylaxis), it works rapidly on several systems to stabilize the body.

Improving Breathing and Blood Pressure

Epinephrine targets specific receptors throughout the body to counteract the symptoms of anaphylaxis:

• Alpha-adrenergic receptors: It causes blood vessels to constrict (narrow). This helps to increase blood pressure, which often drops dangerously during a severe reaction, and reduces swelling in the face, throat, and tongue.
• Beta-adrenergic receptors: It relaxes the muscles in the airways, allowing the lungs to open up so the person can breathe more easily. It also stimulates the heart to beat faster and more strongly.

Stopping the Allergic Response

In addition to treating symptoms, epinephrine helps stop the reaction from progressing. It prevents certain immune cells, known as mast cells and basophils, from releasing more histamine and other inflammatory chemicals into the bloodstream.

Nasal Delivery

Unlike traditional epinephrine treatments that require an injection into the muscle, Neffy is absorbed through the lining of the nose (nasal mucosa). Once sprayed into the nostril, the medication enters the blood vessels in the nasal passage to provide systemic relief throughout the body.

Common Side Effects

The most common side effects reported with this medication involve the nose and throat. These may include:

• Throat irritation
• Tingling or itchy sensation in the nose
• Nasal discomfort or congestion
• Runny nose or sneezing
• Headache
• Nausea or vomiting
• Feeling shaky, nervous, or jittery
• Dizziness
• Fatigue
• Sweating

Serious Side Effects

While less common, some side effects can be serious. Seek emergency medical attention if you experience:

• Chest pain
• Fast, pounding, or irregular heartbeat
• Difficulty breathing
• Severe headache or blurred vision
• Significant increase in blood pressure
• Fainting or extreme weakness

Because this medication is used to treat life-threatening allergic reactions (anaphylaxis), it can sometimes be difficult to distinguish between the symptoms of the allergy and the side effects of the drug. Always seek immediate emergency medical help after using this medication, even if symptoms seem to improve.

Emergency Medical Care

Neffy is intended for immediate use during a severe allergic reaction. After using the nasal spray, it is necessary to seek emergency medical help right away. Medical monitoring is required because the symptoms of anaphylaxis may return as the medication wears off.

Nasal Conditions

The absorption of Neffy may be affected by certain nasal issues. People with nasal polyps, a history of nasal surgery, or chronic sinus congestion should discuss these conditions with a healthcare provider, as these factors might reduce the drug's effectiveness compared to an injection.

Medical Precautions

Epinephrine can affect heart rate and blood pressure. Caution is recommended for individuals with the following conditions:

• Heart disease or high blood pressure
• Irregular heartbeats (arrhythmias)
• Thyroid disease
• Diabetes
• Parkinson's disease

Drug Interactions

Certain medications may interfere with how the body responds to epinephrine or increase the risk of side effects. This includes some antidepressants, such as MAOIs or tricyclic antidepressants, as well as beta-blockers and alpha-blockers. These combinations can lead to severe changes in blood pressure or heart rhythm.

Repeat Dosing

If symptoms of the allergic reaction do not improve or if they worsen after the first dose, a second dose may be administered using a new nasal spray device in the same nostril. No more than two doses should be given for a single episode.

Pregnancy

Epinephrine is the standard first-line treatment for life-threatening allergic reactions (anaphylaxis) during pregnancy. Anaphylaxis is a medical emergency that can result in death or serious harm to both the pregnant person and the fetus if left untreated. Because of these risks, the benefits of using Neffy during an emergency typically outweigh the potential risks of the medication.

There are no adequate or well-controlled clinical studies specifically looking at the use of nasal epinephrine in pregnant women. If you are pregnant or planning to become pregnant, you should discuss the use of this medication with your healthcare provider as part of your allergy management plan.

Breastfeeding

It is currently unknown whether epinephrine administered via nasal spray passes into human breast milk. However, epinephrine is a hormone that occurs naturally in the body and has very low oral bioavailability, meaning it is not easily absorbed through the digestive system. You should consult with a healthcare professional if you have concerns about using Neffy while breastfeeding.

Available Forms

Neffy is provided as a nasal spray. This medication is administered using a needle-free delivery device designed for use in the nose.

• Nasal Spray: The medication is contained in a device intended for a single use. Each device is designed to deliver a dose into a nostril during an emergency.

FDA Approval History

The U.S. Food and Drug Administration (FDA) approved Neffy on August 9, 2024. This approval marked a significant milestone as it is the first epinephrine product for the treatment of anaphylaxis that is administered as a nasal spray rather than by injection.

Approved Indications

Neffy is indicated for the emergency treatment of Type I allergic reactions, including life-threatening anaphylaxis, in adults and pediatric patients who weigh at least 30 kg (approximately 66 pounds).

Regulatory Background

The FDA granted Neffy Fast Track designation during its development to expedite the review of the medication. The approval was based on clinical studies that compared the concentration of epinephrine in the blood after nasal administration to traditional injection methods. These studies demonstrated that the nasal spray provides comparable levels of the medication to help reverse the symptoms of a severe allergic reaction.

There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategies (REMS) associated with this medication.

Estimated Costs

The manufacturer's list price for a two-pack of Neffy is approximately $710. However, the amount a patient actually pays at the pharmacy is typically lower depending on their insurance plan and available financial assistance.

Insurance and Savings Programs

• Commercial Insurance: Patients with private or commercial insurance may qualify for a co-pay savings program that reduces the cost to as little as $25 for a two-pack.
• Uninsured or High-Deductible Plans: For individuals without insurance or those whose insurance does not cover the drug, the manufacturer offers programs such as neffyConnect, which may provide the two-pack for a discounted price of approximately $199.

Factors Influencing Price

Neffy is generally sold as a two-pack because a second dose may be necessary if symptoms of a severe allergic reaction do not improve after the first administration. The final out-of-pocket cost can be affected by:

• Your specific insurance provider's formulary and tier placement.
• Eligibility for patient assistance programs.
• The specific pharmacy used to fill the prescription.

It is recommended to check with your insurance provider or the manufacturer for the most current pricing and to determine which savings programs you may be eligible for.