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Amgevita/Humira in a power cut

How well does Humira or Amgevita last without refrigeration? My Amgevita wouldn't have reached as much as 25°C at any point (what seems to be considered room temperature), but the power cut hit late in the evening, and the fridge had reached about 13°C when I moved it outdoors in the morning. It then appeared to stay between 2°C and 8°C until I was able to put it in the fridge again.

Does the window on the auto-injector pens tell the full story? Or should this not be trusted even if it stays clear and colourless?
 

my little penguin

Moderator
Staff member
Per the humira website the medicine can be stored at room temperature . But once it reaches room temperature -it must be used within 14 days .- at least it used to be that way 5 years ago when my son was in it .
Never used the biosimilar
So no idea there .

There should be a customer contact number on the company website to call
Please call the company


5. How to store AMGEVITA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze.

Store in the original carton in order to protect from light.

A single AMGEVITA pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The pre-filled pen must be protected from light, and discarded if not used within the 14-day period.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
So definitely call the company
 
Location
San Diego
I don't have experience specifically with Humira stability, but based on what I know about stability testing for FDA approvals, there is very likely a reasonable amount of tolerance around storage conditions - meaning that a few hours at a modestly elevated temparature should be fine.

But if the times without refrigeration were lengthy, or if temperatures got downright hot, and especially if the drug was accidentally frozen, then perhaps the stability is questionable.
 
Thanks Scipio and my little penguin for the replies. What about the windows on the pens, does that give any insight into the stability?
 
Location
San Diego
Thanks Scipio and my little penguin for the replies. What about the windows on the pens, does that give any insight into the stability?
As far as I know, the stability of the pens simply follows the stability of the drug in the pens. So what I said about the drug applies to the pens.
 

my little penguin

Moderator
Staff member
Never had humira pen only syringes

We do have epi pens which also have windows for the drug in them as well as safe temperatures ranges for storage
For the epi pen at least
It will not be clear in the window if there is an issue (brown , cloudy . Particles )
But can still be clear in the window even if your outside the recommended temperature and can’t expect the pen and /or meds to work properly -annoying

should be ok but better to call the company directly
Humira has always been very helpful in these situations
 
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