The Essential Guide to Epipen® or Auvi-Q® Temperature Rules

Understand Epipen® and Auvi-Q® temperature control rules for storage to ensure your epinephrine auto-injector is fully effective.

If you, or your child, has life-threatening allergies, you likely know how important it is to have a fully effective EpiPen®, or another epinephrine auto-injector, on hand at all times. But do you remember how to handle it? What if you're going outside in the heat - can you keep it in a cooler with ice? Can you leave it in the car? There's a lot of confusing information about temperature control rules and epinephrine online. This blog post will help you navigate them with ease. 

What Are Auto-Injectors? 

Auto-injectors are designed to treat life-threatening allergic reactions. They are commonly used for people with food allergies or anaphylaxis. The most common auto-injectors here in the United States include EpiPen®, Auvi-Q®, Teva, and Adrenaclick. They all contain a single dose of epinephrine, to be  injected into the thigh to stop symptoms like hives, swelling, vomiting, or wheezy breathing. Auto-injectors are relatively easy to use by anyone. They can be self-administered or used by someone else, for example, in treating a small child. 

Where Should I Store My Auto-Injector?

Whether you have an EpiPen®, Auvi-Q®, Teva, or Adrenaclick, when it comes to their ambient temperature you must follow these rules to ensure the medicine inside your auto-injector does not lose its potency:

Protect From Light: Epinephrine, the drug inside the auto-injector, is sensitive to light and can lose potency if exposed. To provide the best protection from sunlight, keep the auto-injector in its original package. EpiPen® comes in a tube, for example. It should always stay in it.

Keep Away from Extreme Heat or Cold: Epinephrine should be stored between 68°F to 77°F (20°C-25°C). Your epinephrine auto-injector must not get hot or frozen as this may cause the medicine inside to become unstable and lose its effectiveness. 

Keep it in a Controlled USP Room Temperature: The United States Pharmacopeia (USP) has set specific guidelines for appropriate temperatures for medicines. These standards are the basis of most pharmacy and health care guidelines nationwide. A USP controlled room temperature is a temperature that is maintained thermostatically within 68°F to 77°F (20°C to 25°C). 

The Don'ts: 

When it comes to storing your auto-injector, there are many things to avoid, including:

  • Do not refrigerate your auto-injector. 
  • Do not keep it in a freezer.
  • Don't leave it in your vehicle's glove box, car seat, or any other place that could get extremely cold or hot. 
  • Don't store it in any place where the temperature could go above or under the recommended range. 

What If My Auto-Injector is Accidentally Exposed to Extreme Temperatures?

It happens. You might be at the pool, and the auto-injector is left in your bag or purse under the hot sun. Or you might forget to take it out of your car after parking in the garage on a cold winter or hot summer day. The manufactures say those excursions can be okay as long as they are within the following two rules:

  1. The temperature excursion stays between 59° and 86 °F (15° and 30°). 
  2. The excursion does not last more than 24 hours.

Note: The excursion is contingent upon the so-called mean kinetic temperature (MKT) not exceeding 77°F (25°.) To calculate the MKT, there is the following complex mathematical formula, which you don't really need to know if you ALWAYS remember to keep your auto-injector between 68°F to 77°F (20°C-25°C). And if you are like most people with one too many things to remember, don't worry. Thanks to technology, there is a solution that will guarantee you will never forget to keep your auto-injector with you. It will also alert you immediately if the device is exposed to extreme temperatures. You will learn more about that groundbreaking solution called EpiReminder at the end of this article. 

Epipen Mean Kinetic Temperature Calculation

Let’s take a look at a couple of normal examples and how they fare in the MKT calculation (Note in all of these examples I use temperatures already outside the excursion temperature range, so even short exposure to this temperature could damage the epinephrine. However, it’s useful to see how impactful these temperature spikes are compared to a full day):

Example 1 (At the Pool): 

On a recent trip to the pool on a hot day,  I measured a temperature of 98 degrees in our insulated bag.  But to go further, let’s imagine we stayed at the pool for 3 hours at this temperature.  Then, we went home and ensured the epipen was 72 degrees F the rest of the day. According to the mean kinetic temperature calculation, the temperature profile of the medication was as if it was stored at 78.2° for 24 hours, or above the ideal temperature range. 

Example 2 (Hot Car):

On a hot day, the inside of your car can reach temperatures of 140°F in 20 minutes. If we leave our Epipen at this temperature for just 2 hours and then maintain a 72°F temperature for the remainder of the day it would be as if it was stored at 98°F the whole day, far exceeding even the excursion temperature max.

Example 3 (Cold Car Overnight):

After coming home from dinner, you leave your epipen in the car. Overnight, the temperature gets down to 35°F (obviously, in many locations, cars get much colder than this) - 12 hours later, you remember you left it in the car and return it to room temperature of 72°F.  Forgetting in the car for this scenario is as if you stored at 62°F for a full day, below the ideal temperature range.

What Happens If I Accidentally Expose My Auto-Injector to Extreme Temperatures?

If your auto-injector has been exposed to extreme temperatures, such as the car seats in the summer months or when left near a heater during winter, it may not work during an emergency. If that happens, you should immediately contact your healthcare provider or pharmacist and ask whether you should discard the device and get a new one. They will typically ask you questions about the type of device you have, the amount of time it was exposed to extreme temperature, and whether the device has visible signs of damage. EpiPen, for example, has a window showing a clear liquid inside. If that liquid is discolored, it could be a sign that your auto-injector needs to be replaced. To view real-life experiments, I highly recommended reading through Eileen’s at-home experiments on her blog, The Allergy Superheroes. These experiments are especially useful in understanding not just the detriment to the medication but also to the auto-injector device itself. Many of those tested didn’t even fire!

Potential Consequences of Exposing an Auto-Injector to Extreme Temperatures

If your epinephrine auto-injector is exposed to a temperature outside the recommended range, research shows that it can lead to one or all of the following four problems:

  • Loss of Assay:  This is the most common problem caused by exposure to extreme temperatures. The epinephrine in your auto-injector may no longer be effective because it has been exposed to a temperature outside its correct storage range. This means that the medication may not work to relieve your life-threatening allergic reaction if you need it later.
  • Increase of Impurity:  The epinephrine in your auto-injector may become impure because of the extreme temperature change, which can lead to a less effective treatment or even adverse effects like swelling at the injection site. Epinephrine is a hormone, and like all hormones, it can be affected by extreme temperatures. If your epinephrine undergoes a structural change, it may fail to relieve symptoms.
  • Separation of Layers of Liquid Products: The epinephrine solution in auto-injectors manufactured in the United States and Canada contains epinephrine, sodium chloride, and either sodium metabisulfite or sodium bisulfite. The epinephrine in your auto-injector can be separated by the rapid change in temperature, and if this happens, you may not get a full dose or any relief at all.
  • Discoloration: Exposing your device to excessively high or low temperatures can lead the device's epinephrine product (a clear liquid) to turn brownish-yellow, a sign that your medication has been compromised. It may not achieve the expected result in an emergency due to degradation of potency. Remember, research shows that epinephrine degradation can occur without any visible change in color.

How to Ensure My Auto-Injector is Safe and Ready to Use When Needed?

There are relatively inexpensive insulated cases such as Frio®, PracMedic®, and Allermates® that are designed to protect your products from the effects of extreme temperatures. You might want to get one of these cases to help protect your auto-injector from sudden temperature changes.

More than 30 million Americans have food allergies. Every year, over 200,000 people are hospitalized for emergency treatment because of food allergies. 

Having your auto-injector with you and kept in a safe environment is essential to respond quickly and effectively in the event of a severe allergic reaction. It can make the difference between life and death.

But in today's fast-paced world, it's easy to forget about your auto-injector. It's hard to know if it is near enough to your child at school. It's virtually impossible to know if it is at the right temperature at all times. For those reasons, you need EpiReminder, a revolutionary mobile app and tag for your epipen that connects you with your medicines to help you be prepared on the go. EpiReminder sends you alerts whenever any of the following two issues arise:

  1. You or your loved one that needs the auto-injector is not close enough to the device.
  2. When your auto-injector becomes too cold or too hot.

With Epimider, you can achieve peace of mind. It is now easier than ever to always have your auto-injector close by and at the right temperature, no matter where you are or what time it is.

Signup for EpiReminder’s Pre-Order list today! A limited supply of these devices will be released this July.

 

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