Levemir Going Off

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Simon Quinnell DAFNE Graduate
Maidstone General Hospital
16 posts

I have a perplexing problem. Over the past 3-4 weeks my blood sugars have been very high (15-1Cool most of the time. Applying DAFNE principles made no difference. I was not unwell, and had no ketones. My routines and eating habits have not changed. After a process of elimination I discovered that changing to a new batch of Levemir cartridges solved the problem, however, I am at a loss as to why it appears to be going off. When I get the cartridges from the pharmacy I put them straight in the fridge, and they stay there until I need them. The cartridge in my pen is at room temperature. I have a digital thermometer in my lounge. The temperature rarely exceeds 25C, and the insulin packaging says Levemir in use will stay fresh for up to 6 weeks, up to 30C. I don't leave the pen anywhere hot. The expiry date on the pack reads 05/2013. The insulin is crystal clear in the cartridge.

When I get a repeat prescription, I get 2 packs (10 cartridges). Each cartridge lasts me approx 20 days, so I will get through all 10 in about 8 months.

This is not the first time this has happened, and always seems to occur when I get to the last couple of cartridges. I have run out of ideas. Am I overlooking something?

Thanks for your help.

Simon.

novorapidboi26 DAFNE Graduate
NHS Lanarkshire
1,774 posts

What is the shelf/fridge life of Levemir........

It might be losing its potency nearer the 8 month mark........

This is because you are getting 2 packs of Levemir at once......

I use the disposable flex-pen for my Levemir, and I only get one pack, so 5 x 300ml injections [300 units], I use 60 a day, so including priming/wastage, your looking at about 3 days use, so just over 2 weeks for one pack.....

so your not that far off me, but it might be wise to just get one pack a time........

JayBee DAFNE Graduate
James Paget University Hospitals NHS Foundation Trust
765 posts

Funny this has come up - I've very recently started monitoring my usage of both insulins after someone I follow on Twitter expressed some concerns about Lantus' life time once out of the fridge. I'm also on Levemir so this is interesting to know. I will see what happens with me too.

Doesn't say too much on the paper that comes in the box (Under 5. How to Store Levemir):
~Do not use Levemir after the expiry date which is stated on the cartridge label and carton are EXP. The expiry date refer to the last day of that month.
~You can carry it with you and keep it at room temperature (below 30C) for up to 6 weeks.

Does 6 weeks sound about right? :/ I'm not sure.

Simon Quinnell DAFNE Graduate
Maidstone General Hospital
16 posts

Thanks for the idea novorapidboi. It's worth a try! I'll request my GP to send only one 5 pack next time, and see what happens.

RichFreed DAFNE Graduate
Princess Alexandra Hospital, Queensland
51 posts

It would seem to me that if you have followed the storage specs and are within the expiry date then this issue needs to be reported (since it's not the first time - could be any number of issues outside of your control eg a transport & storage procedure that has broken down prior to reaching you in the first place). At the very least the unused ones should be replaced for you (each time it happens).

Gleened this off Google for you.

RECOMMENDED ECOMMENDED STORAGE
Unused LEVEMIR should be stored between 2° and 8°C (36° to 46°F). Do not freeze. Do
not use LEVEMIR if it has been frozen.

Vials:
After initial use, vials should be stored in a refrigerator, never in a freezer. If refrigeration is
not possible, the in-use vial can be kept unrefrigerated at room temperature, below 30°C
(86°F), for up to 42 days, as long as it is kept as cool as possible and away from direct heat
and light.

Unpunctured vials can be used until the expiration date printed on the label if they are
stored in a refrigerator. Keep unused vials in the carton so they will stay clean and
protected from light.

PenFill cartridges, FlexPen , or InnoLet :
After initial use, a cartridge (PenFill ) or a prefilled syringe (including FlexPen or InnoLet )
may be used for up to 42 days if it is kept at room temperature, below 30°C (86°F). In-use
cartridges and prefilled syringes in-use must NOT be stored in a refrigerator and must NOT
be stored with the needle in place. Keep all cartridges and prefilled syringes away from
direct heat and sunlight.

Not in-use (unopened) LEVEMIR PenFill , FlexPen or InnoLet can be used until the
expiration date printed on the label if they are stored in a refrigerator. Keep unused
cartridges and prefilled syringes in the carton so they will stay clean and protected from
light.

marke Site Administrator
South East Kent PCT
641 posts

Hi Rich is correct you should report this to your pharmacy. Every batch of any prescription drug can be traced from manufacturer all the way through to the dispensing pharmacy. If you suspect a batch is 'faulty' you should report it to the pharmacist. They can then get it investigated and ideentify if there is an
issue. You can find the Batch Number and Expiry Date on every pen near the base. In the case of Insulin it should be transported and stored at all stages
in temperature controlled storage. It makes no difference if you get 2 boxes and keep them in the fridge or one since you are storing them in the temperature range required.

chrisinbrum DAFNE Graduate
University Hospitals Birmingham NHS Foundation Trust
41 posts

Have you considered that the pen device might be faulty and therefore not giving you the units you are dialling up? Are there any recommendations for how long a pen is 'reliable' for or how often they should be replaced?

Pepsi DAFNE Graduate
Cambridgeshire
8 posts

I have just been given a new cartridge pen, and the leaflet said a life of 3 years.

novorapidboi26 DAFNE Graduate
NHS Lanarkshire
1,774 posts

After looking at the documentation it would seem that the insulin pens you are using can last for a longer time than you are experiencing problems at......

So it might be just a faulty batch of pens.....

The insulin can also be damaged if exposed to freezing temperatures....

Simon Quinnell DAFNE Graduate
Maidstone General Hospital
16 posts

Hi All,

I know this thread is now quite old, so thank you for all your feedback, however, I've stumbled across an article tonight which may explain why my insulin is going off!

https://medicalxpress.com/news/2018-02-insulin-quality-diabetes-experts-scrambling.html

What do you think?

Simon.