How Long Can Dupixent Stay Out Of The Fridge Without Going Bad?

If you live with Asthma, Eczema, or other allergic and inflammatory conditions, you may have been prescribed Dupixent. After your doctor has proceeded to the first subcutaneous injections, he sent you home with your new prescription. At the pharmacy, you’ve probably been told to put your new medicine in the fridge as soon as you get home.

Indeed, Dupixent is a very sensitive biological drug that requires specific storage temperatures. While storing Dupixent in your fridge seems easy, more than 80%[1] of people taking similar biologics don’t store them properly.

Yet, observing pharmaceutical cold chain procedures is essential to keep temperature-sensitive medicines like Dupixent active and functional.

So, how exactly should your store your Dupixent pens and syringes? How long can they safely stay out of the fridge? What happens if Dupixent is left unrefrigerated? And how to tell if it has gone bad?

What is Dupixent?

Dupixent is the brand name of dupilumab, an FDA-approved biologic drug used for respiratory and allergic conditions like eczema, asthma, eosinophilic esophagitis, and others.

It belongs to the monoclonal antibody class of drugs. It works by interfering with the immune system and blocking two natural proteins in the body (interleukin-4 and interleukin-13) that are responsible for inflammation and swelling.

Dupixent may be indicated for patients with severe dermatitis (eczema) where other therapies have not worked or cannot be used. It also helps prevent severe asthma attacks and improves breathing when used in combination with other asthma medicines. It may also be prescribed to patients with chronic rhinosinusitis and nasal polyps as well as eosinophilic esophagitis.

After the first injections are given at the doctor's office, Dupixent is usually prescribed for home treatment. It comes in prefilled single-use syringes or auto-injectable pens and is usually injected once every other week or once every 4 weeks depending on the patient’s age and weight.

Like any medication, Dupixent may cause some side effects including allergic reactions, eye problems, joint pain, or others.

If you're more of a visual learner, here's our video about good storage practices for your Dupixent injections:

Dupixent Storage Instructions

Dupixent is a biological drug. It means that it comes from living sources (plants, animals, or humans). As such, it is very sensitive to temperature and light changes and can quickly go bad if not stored properly. If you’ve been prescribed Dupixent injections at home, here’s how you should store your medicine:

Dupixent must be stored in the fridge

According to Regeneron Pharmaceuticals and Sanofi Genzyme, the developers of Dupixent, dupilumab must be stored in the fridge at 36°F - 46°F (2°C - 8°C). Once taken out of the fridge, Dupixent can stay at room temperature (77°F or 25°C) for up to 14 days maximum.

Concretely, it means that you must keep any unopen Dupixent prefilled syringes or pens in your home refrigerator as soon as you get back from the pharmacy. Once a syringe or a pen has been open, used, or kept out of the fridge for more than a few hours, it must be used within 14 days max.

During these 14 days, in no instance should your medicine be exposed to temperatures above (77°F or 25°C). If you need to travel or if your next injection will occur away from home and outside temperatures are higher than that, you must use a portable medicine cooler.

4AllFamily's medical-grade travel coolers have been designed to keep drugs like Dupixent refrigerated in any situation

Dupixent must be protected from light

Exposure to too much light may also deteriorate Dupixent. When stored in the fridge, make sure to keep your medicine in its original carton so it's protected from the refrigerator light.

If you need to take your pens or syringes for your next injection away from home, keep them in your purse or anywhere away from direct sunlight.

Dupixent should never freeze

According to the manufacturing laboratory, Dupixent should not freeze. While the injectable asthma and eczema medicine should be kept cold to stay effective, too cold isn’t good either. Freezing temperatures deteriorate biological drugs. Do not use Dupixent if it has frozen, even if it has thawed afterward.

To prevent your valuable injections from freezing, make sure to store them far away from your fridge’s freeze compartment. If you use a medical travel cooler with ice, always wrap your pens or syringes in a cloth so they’re not in direct contact with ice. Never leave your medicine in the car overnight when temperatures might get below 32°F (0°C). In extremely cold temperatures, slip it into an inside pocket. Your body's warmth should be enough to prevent it from freezing.

What happens if Dupixent isn’t refrigerated?

Biological drugs made from living sources like Dupilumab are extremely sensitive to temperatures. Storage at elevated temperatures may lead to irreversible denaturation of the medicine and loss of its biological activity. Consequently, Dupixent that has not been stored properly may lose efficiency. In the most extreme cases, the medicine can even go bad and be contaminated, although that's a rare scenario.

How long exactly can Dupixent stay out of the fridge?

According to Regeneron Pharmaceuticals and Sanofi, Dupixent can stay out of the fridge for up to 14 days. During these 14 days, Dupixent must be kept at room temperature below 77°F - 25°C.

It’s important to understand that biological antibodies like Dupilumab are extremely sensitive to both high temperatures and temperature changes. The most constant the storage temperature is, the better. Even room temperature is sometimes too warm for biologics. That’s why most of them like in s ulin, Humira, Ozempic, Mounjaro, or Dupixent start deteriorating after a few days out of the fridge.

Dupixent that has been unrefrigerated for more than 14 days or that has been exposed to temperatures above 77°F - 25°C even temporarily isn’t safe for use anymore. Throw your pen or syringe away and get a new one from the fridge or the pharmacy.

Related article: Does Asthma Affect Travel Insurance?

How to tell if Dupixent has gone bad?

Dupixent may go bad in two cases: if the expiration date has passed or if it has not been stored properly.

You can find Dupixent expiration date on the single-dose prefilled syringes or pens. Passed that expiration date, the medicine inside isn't safe for use anymore. It may go bad and its efficiency and safety may be compromised.

There's a viewing window on the syringe that lets you see the liquid inside. Before use, always check that your medicine looks clear and colorless. Visual signs that Dupixent has gone bad include a pale-yellow color, discoloration, cloudiness, bumps, or strings inside.

When in doubt, dispose of your medication and get a new unopen device from your fridge or the pharmacy.

References:

[1] Santin, G., da Silva, M.M.M., Villarreal, V.A. et al. Home storage of biological medications administered to patients with rheumatic diseases. Adv Rheumatol 60, 30 (2020). https://doi.org/10.1186/s42358-020-00131-x

September 27, 2022

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Comments

4AllFamily Customer Care Team said:

Hi Kathleen,
It should be safe if it was only out of the refrigerator for a few hours. However, it depends how long exactly and at what temperature. In no case should Dupixent be exposed to temperatures above 77F / 25C.
If you have doubts about how long it’s been out of the fridge, use it within 14 days max, or ask for advice at the pharmacy.
Warm regards,
4AllFamily Customer Care Team

Kathleen Cupolo said:

Is Dupixent safe to use if left out of refrigerator a couple of hours and then put in the refrigerator?