Needle-Free Epinephrine: What Parents Need to Know

Epinephrine is the only treatment for anaphylaxis, a potentially severe life-threatening allergic reaction. Currently, we can only give this medication with a needle. This has contributed to lots of fear and anxiety about using these devices.

Whether it’s eggs or shrimp or a bee sting that leads to the lip swelling, trouble breathing, coughing, vomiting, itchy hives, increased heart rate, low blood pressure – all signs of an allergic reaction – epinephrine starts to reverse the symptoms within minutes. It can save your child’s life and that’s why access to this medication has been important and why a device that can deliver this medication without a needle is making a splash not only in the medical community, but also in the news.

Information about the device is outlined below, but please talk with your child’s doctor about whether this could be an option.

A pharmaceutical company has been working on a device to deliver the medication through a nasal spray. The U.S. Food and Drug Administration which oversees the approval process for new medications, approved this device in August 2024. The product was approved through the “Fast Track” designation which moves the process along more quickly for medications for serious medical conditions.

This device was not studied in people who were experiencing anaphylaxis; however, it was studied in 175 healthy adults along with the traditional epinephrine that is injected into muscle and the data captures an appropriate and expected rise in nasal and bloodstream levels. Both delivery routes resulted in similar increases in blood pressure and heart rate.

If you paused at “not studied in people who were experiencing anaphylaxis,” know that we actually don’t have any randomized controlled trials even with traditional epinephrine injections because it wouldn’t be ethical to not give people the lifesaving medication in potentially life-threatening situations. We just know that it works based on all of our overwhelming real-life experiences with this medication and allergic reactions.

Some important details about the new nasal epinephrine device:

• The dose in one spray of nasal epinephrine is 2 mg (which is a different dose from the muscle injectors).
• If there is no improvement in symptoms, a second dose should be given in the same nostril five minutes after the first dose.
• This device and dose are only approved for pediatric and adult patients who weigh 30 kilograms (66 pounds) or more. It’s currently being studied in the people who weigh less than 30 kilograms.
• The device should be inserted straight into the nostril with normal breathing. Do not direct towards the middle or outer part of your child’s nose.
• The most common adverse reactions reported in the studies were throat irritation, nasal discomfort, sneezing, headache and feeling jittery.
• Each kit will contain two devices, and they don’t expire for 30 months. This is different from the traditional muscle injectors that expire 12 months after they’re made.

This device is now available at retail pharmacies and one online pharmacy. Three potential outcomes can occur when ordering from a pharmacy:

1. A $25 co-pay for commercially insured patients
2. A cash option if you don’t have insurance coverage ($199)
3. Access to the patient assistance program through the manufacturer as needed.

The device can be shipped to your home directly at no charge, after the prescription and processing have occurred. Look at the cost for each device and even though this intranasal epinephrine may be more expensive upfront, it lasts longer and may be worth it in the long run.

Medicaid will start covering this medication on January 1, 2025.

We know that one of the reasons people are less likely to use traditional muscle injectors is because they’re scared of needles, but it’s important to carry your child’s emergency epinephrine if you have a medical condition that could potentially require this treatment.

Which device you end up using, whether it’s the traditional injector or nasal spray, should be discussed with your child’s allergist to help assess the patient’s medical condition, previous allergic reaction history, what your personal risk of having an allergic reaction is, and whether nasal epinephrine would be appropriate.