What can really happen if Enbrel is left unrefrigerated?

Enbrel is a subcutaneous injectable prescription medication used to treat the symptoms of various chronic conditions such as rheumatoid arthritis (RA), psoriatic arthritis (PA), ankylosing spondylitis (AP), plaque psoriasis, and Polyarticular juvenile idiopathic arthritis. Etanercept, its active ingredient, helps decrease inflammation to reduce the pain and symptoms associated with these diseases.  

Like most liquid injectable medicines, including other ones used in the treatment of the same chronic conditions such as Humira, Actemra, Cimzia, Orencia, or Simponi, Enbrel is highly sensitive to temperatures. It must be refrigerated when not in use and can only be left at room temperature for up to a maximum of 14 days.

If you’re one of the many patients who have been prescribed Enbrel, you might wonder how exactly you should store your valued medicine. Here’s a FAQ article focusing on the storage and refrigeration of Enbrel pens and syringes at home.

Related article: 7 Great tips for traveling with Psoriatic and Rheumatoid Arthritis

How long can Enbrel be unrefrigerated?

Enbrel is usually administered once a week either at your doctor's office or in most cases at home by yourself. It comes in the forms of prefilled syringes, prefilled Sure Click autoinjector pens, single-dose prefilled cartridges, or in rare cases powder. It’s a fragile biologic medicine that can quickly deteriorate and spoil if not properly kept at the right temperatures.

Related article: What drugs are refrigerated? List of medicines that require refrigeration

Enbrel temperature sensitivity

Enbrel is highly sensitive to temperatures and temperature changes. According to Immunex Corporation, Enbrel’s manufacturer, it must be stored at fridge temperature, that is to say, 2°C-8°C / 36°F-46°F which is the standard temperature range for domestic refrigerators.

When properly stored in the fridge, your Enbrel pens, syringes, or cartridges are good until the expiration date that is printed on the label.

Once you’ve taken Enbrel out of your fridge, it can be kept “at room temperature between 20°F-25°C / 68°F-77°F for up to 14 days”. During that time, Enbrel should never be exposed to temperatures above 25°C/77°F. It means that whether you're going down the block or traveling across the country with Enbrel in your bag, you must make sure it's protected from the outside heat. In most cases, if you live in or travel to places where the ambient temperature gets higher than that, you'll need to use a medical cooler.

After 14 days have passed since you’ve taken Enbrel out of the fridge for the first time, it isn’t safe for use anymore and must be disposed of.

What happens to Enbrel without refrigeration?

Enbrel is a biological medicine. As opposed to most drugs that are chemically synthesized, biologic drugs, also called biopharmaceuticals or biologics, come from living sources, microorganisms, plants, or human and animal cells. As such, they are heat sensitive, can easily spoil, and are prone to microbial contamination.  

Temperature changes affect the efficacy, bioavailability, and immunogenicity of biopharmaceuticals like Enbrel. Exposure to high temperatures has proven to denature these medicines and make them lose their efficiency. In other words, Enbrel pens or syringes that have not been refrigerated or stored properly may be spoiled and are not safe for use anymore.

In the same category of biologics that are heat sensitive, common examples are Humira, Enbrel, Rituxan, and some insulins like Lantus.

When your life depends on such temperature-sensitive medications, it brings a bunch of challenges and concerns. Living and traveling with refrigerated drugs requires discipline, good organization, and a great medical cooler!

Related article: Tips for traveling with Enbrel + Enbrel travel bag

 

Get a medical travel cooler to keep your Enbrel refrigerated in any situation!

What happens if Enbrel gets frozen?

Like most biological drugs, Enbrel cannot freeze. It's expressly stated the manufacturer's instructions for use. The protein structure of biological drugs may change during the freezing process. Enbrel that has frozen is not good for use anymore, even if it has thawed afterward.

Situations where your Enbrel might freeze are more frequent than you would think. Here are a few ideas to prevent Enbrel from freezing:

  • Never leave Enbrel in your car overnight if temperatures may get below 0°C-32°F
  • Don’t store it next to the freezer compartment of your fridge
  • If you live or travel to extremely cold places, keep your Enbrel pens or syringes in an interior pocket. Your body's warmth should be enough to prevent it from freezing.

If you doubt whether or not your Enbrel pen or syringe has frozen, even for a short period of time, do not use it. Dispose of it immediately and get a new one from the fridge or the pharmacy.

Is re refrigerating Enbrel a good idea?

No. Once Enbrel has left the fridge, you should not put it back into it. Enbrel may be left unrefrigerated for up to 14 days (if protected from light and heat). But once it’s been out of the fridge for more than 15 minutes and has reached room temperature, it can’t be placed back in the refrigerator.

If you have not used your Enbrel pen or syringe within 14 days, discard them and get new ones from the pharmacy.

What about Enbrel expiration date?

If Enbrel is constantly stored in the fridge without any break in the cold chain, it’s good and safe for use until the expiration date that is printed on the label.  

Enbrel is a clear and colorless liquid. It’s ok if you see small particles in it, but if you notice that the medicine is cloudy, discolored, or contains large lumps or flakes, it might have gone bad. When in doubt, do not use it and get a new pen, syringe, or cartridge.

We hope this article has made things clearer for you and you now feel comfortable about the storage of your Enbrel! If not, please share your doubts in the comment section. We’d be happy to help you out!