Lantus temperature sensitivity and other info

[Alan Hamman]

I have been asked a lot about the ability of Lantus to be out of refrigeration without damage. I have a link from the Lantus Physicians site that has a lot of Lantus information. The chart 16.2 "Storage" at the link below shows the ability of Lantus to be kept out of the refrigerator without damage for 28 days. In another document that I am looking for so I can post it here, they tested Lantus for 30 days at 103F the results were "no loss of activity". There was yet another document I read that stated it could be stored in the refrigerator between doses, and sterility was a major part of the recommendation to discard at 28 days after opening. I will try to post more when I get the time. All that said keeping it in the fridge as much as possible makes it last longer.

LINK HERE for the document mentioned with chart 16.2 in it

 

[tiffmaxee]

So many of us have used lantus for 5-6 months and keep it stored in the refrigerator. In the almost 4 years in this site I’ve never heard of anyone having sterility issues.

 

[Alan Hamman]

So many of us have used lantus for 5-6 months and keep it stored in the refrigerator. In tge almost 4 years in this site I’ve never heard of anyone having sterility issues.

My thoughts....It isn't that you should expect sterility issues. The company wanting to steer clear of any slight possibility of lawsuit for human use decided that sterility might be an issue. Carrying through on that they state not to share the pens even if you install a new needle. Their expectations for it's users are pretty low, their worst nightmare is for someone not being careful enough to have a sterility problem. So that was why they recommended to discard after 28 days, plus they sell more product if you throw it away, and buy a new pen. I have seen people use a single pen for months storing it in the fridge in between doses with no problems at all.

 

[Chris & China (GA)]

The 28 day limit was set because that's all that the manufacturer asked the FDA to test for.....so "legally", they have to say it's only good for 28 days since no "official" testing was done after that.

They don't want the pens refrigerated because there have been problems with the "dial a dose" mechanism failing to work properly, but since we use regular insulin syringes to pull the insulin out of the pen, that's not an issue for us.

 

[Squalliesmom]

My thoughts....It isn't that you should expect sterility issues. The company wanting to steer clear of any slight possibility of lawsuit for human use decided that sterility might be an issue. Carrying through on that they state not to share the pens even if you install a new needle. Their expectations for it's users are pretty low, their worst nightmare is for someone not being careful enough to have a sterility problem. So that was why they recommended to discard after 28 days, plus they sell more product if you throw it away, and buy a new pen. I have seen people use a single pen for months storing it in the fridge in between doses with no problems at all.

That's exactly what my vet told me about all the insulins we use!

 

[Alan Hamman]

The 28 day limit was set because that's all that the manufacturer asked the FDA to test for.....so "legally", they have to say it's only good for 28 days since no "official" testing was done after that.

They don't want the pens refrigerated because there have been problems with the "dial a dose" mechanism failing to work properly, but since we use regular insulin syringes to pull the insulin out of the pen, that's not an issue for us.

You have to remember that Lantus was designed to be carried for human patient convenience, where the pen you are currently using doesn't need to be refrigerated. That is the primary reason they tell you take it out of the fridge and leave it out for 28 days. Also to be FDA approved for human use they have to be very reliable. When Lantus first came out I requested all the documentation available for it which they sent to my lab. It was about 500 pages, and I studied it a while. Everything in the original post was from that manual. Sterility? some patients are not clean enough. Be extra clean and it isn't an issue is what I always tell everyone.

The reason for my post was to help those who didn't understand the ability for Lantus to spend time out of refrigeration without loss of activity.

 

[Sienne and Gabby (GA)]

I agree with everything you noted. An additional point is that most people, especially if they travel, keep their pen unrefrigerated. Pharmacies will keep boxes of pens in the refrigerator until dispensed. It may not be necessary but it seems to be what they do. The major concern I've encountered is repeatedly changing the temperature of the pen -- leaving it out for a few days then refrigerating for a few days all over the lifetime of the pen which is typically longer than a human uses a pen. The concern has been less with the insulin than either with the dispensing mechanism or the way the internal plug moves down the cartridge in order to maintain the internal pressure and prevent excess air from getting into the cartridge.

Also, just to be clear, we're all addressing the use of a Solostar pen and not a vial.

 

[Alan Hamman]

I agree with everything you noted. An additional point is that most people, especially if they travel, keep their pen unrefrigerated. Pharmacies will keep boxes of pens in the refrigerator until dispensed. It may not be necessary but it seems to be what they do. The major concern I've encountered is repeatedly changing the temperature of the pen -- leaving it out for a few days then refrigerating for a few days all over the lifetime of the pen which is typically longer than a human uses a pen. The concern has been less with the insulin than either with the dispensing mechanism or the way the internal plug moves down the cartridge in order to maintain the internal pressure and prevent excess air from getting into the cartridge.

Also, just to be clear, we're all addressing the use of a Solostar pen and not a vial.

I don't think anyone will have problems with cycling hot/cold on the solostar pen. The pens have to meet repeated high standards beyond reason to be accepted for human use. Even if problems did arise insulin can be extracted from the pen with a syringe. I look at the fact that Lantus is resistant to heat, and that is a positive. Then I look at the fact that Lantus lasts longer under refrigeration, and that is a plus too. So if it needs to be out of the fridge for transportation or a vacation it is very good that the Lantus is tolerant of being out of the fridge. And the fact that you can prolong its life by keeping it refrigerated is good, especially for the use on pets where small doses are the norm. New insulin's are being developed that are less and less temperature sensitive, there is one available now that can be kept out of the refrigerator for 90 days.

 

[Bobbie And Bubba]

I am so glad you posted this. I have actually quoted your information your sent to me by PM about the temp stability of Lantus when I questioned that the Lantus you sent to me was not on ice. Your info gave me a lot of comfort. And as Chris said above and my Walmart pharmacist said the same, a 28 day expiration date has to be put on the pens for the FDA. What he said to me was that date was more because it was assumed that the pens would NOT be refrigerated.

 

[Sienne and Gabby (GA)]

I would not remove Lantus from it's container. It would dramatically increase the risk of contamination.