Mounjaro can be stored past 30 days if always refrigerated??

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Okay I've read so many discussions around this and I've searched including Eli Lilly's website and I agree with the few people who seem to have figured out (have they or are we wrong?) that Eli Lilly has kept the statement surrounding fridge storage a bit vague (for whatever reason, some people say because of tests not going further than 30 days but which doesn't prove anything past 30 days; others say it's so they can make money off us buying MJ pens every month. I don't know what to think here).

Most of us know or have been told that we need to discard Mounjaro kwikpen after 30 days of first use but what Eli Lilly hasn't expressly stated is if this includes when stored in the fridge all the time. Their writings typically mention room temperature, then further vague statements about discarding it after 30 days without ever mentioning refrigerated pens.

Here's the screenshot and excerpt of what I'm talking about from Eli Lilly's website:

"How should the Mounjaro® (tirzepatide) KwikPen® be stored?

Store an unused KwikPen in the refrigerator between 2ºC – 8ºC. Protect the medicine from light and do not freeze. After first use, patients may store their pen at room temperature up to 30 °C and dispose of it after 30 days."

Here's another one and note the circled part on the pic (and bolded on here) where it seems to infer (or basically state) that the 30 days is only based on room temp storage...OR am I reading it wrong?

"What are the recommended storage conditions?
Unused KwikPens 1,2

must be stored in the refrigerator between 2 ºC – 8 ºC.
Do not freeze. Discard if frozen.
May be used until the expiration date printed on the label if the KwikPen has been kept in the refrigerator.
After first use, the patient may store the used KwikPen1,2

at room temperature up to 30°C
away from heat and light,
The KwikPen;

must NOT be stored with the needle attached, to prevent leaking, blocking the needle and air entering the pen.
must be stored with the pen cap attached.
The pen must be discarded after 4 weekly doses and must not be used more than 30 days after the first use.

How should wholesalers, HCPs and pharmacies store Mounjaro KwikPen?
During shipping and storing by wholesalers, health care professionals (HCPs) and pharmacies, Mounjaro must be kept between 2°C and 8°C.3

The 30-day room temperature exposure allowance refers to the used pen, and wholesalers, distribution Centers, HCPs and pharmacies cannot use any part of this allowance."

Here's the link to the screenshots/excerpts so you can see it for yourselves.

medical.lilly.com/uk/products/answers/how-should-the-mounjaro-tirzepatide-kwikpen-be-stored-217607

Now this is what spurred me into looking into this, a post on Facebook where someone insistently posted a screenshot supposedly from Asda Online Doctor which expressly states you don't need to discard after 30 days if refrigerated. I say "supposedly" because there was no link to verify if it came from Asda OD or not. Upon searching Asda OD myself, I couldn't find the specific screenshot the poster shared but I found another screenshot which sort of uses a similar vague language towards fridge storage but clearly states 30 days after room temp.

Here is the screenshot of the poster that I couldn't verify (Sorry i dont have it in written format so i can't copy and paste it here as an excerpt).

Here is the screenshot/excerpt of what I did find, which sort of supports the poster's unverified screenshot.

"How should I store Mounjaro?

Store Mounjaro in its original packaging, out of reach and sight of children. Don’t use it after the expiration date on the pen label. You can store Mounjaro in the fridge between 2°C and 8°C, but make sure it doesn’t freeze. You can also store Mounjaro out of the fridge, but not above 30°C, for up to 30 days. After 30 days out of the fridge, Mounjaro should be discarded.

How long can Mounjaro be out of the fridge?

Mounjaro should ideally be kept in the fridge, but it can be stored unrefrigerated for up to 30 days. If you keep Mounjaro out of the fridge, it must not exceed temperatures above 30°C. It should not be exposed to light, so keep it in its original box or a medication box."

Here is the link to the Asda OD site so you can verify for yourselves too. You'll need to scroll down a bit to get to it.

https://onlinedoctor.asda.com/uk/mounjaro

So all this leads me to wonder if indeed the answer to this somehow popular question and discussion on MJ forums and groups online (more so on others than mumsnet but a thread on here today also spurred me to locate the facebook post and do some searches) about 'do we really have to discard after 30 days if kept in the fridge' is "No we don't"? I don't know.

Due to the vague language from the manufacturer specifically, I personally cannot recommend this to anyone but I'm not going to discourage anyone from doing so either unless someone can show me a clearly expressed statement from Eli Lilly that the pen must be discarded after 30 days of first use if kept in the fridge at all times. Not a clumsily worded sentence or a vague blanket statement about storage but one that is as clear as where they clearly stated that you must discard after 30 days if stored at room temperature. Even when someone said on Reddit that they contacted Eli Lilly to clarify storage, I don't think they got a straight statement about fridge storage or got any response at all (I can't remember as it's been at least a month I saw that).

(There are 2 more screenshots that i can't remember where i found to get the links while I was searching, one was from facebook as well. They also support similar statements surrounding storage but feel free to ignore since they're unverified. I'm posting them after this post since I can only share a certain number of photos in one post.)

So what are your thoughts on this?

Please, I'm looking for honest thoughts and not insults as some posters tend to do about this. Thanks for reading x

No it clearly isn't what is written. You're simply writing your own words (of understanding) in addition to what is written. Clearly you understand it differently, that's fine.

Yes I understand that they have this rule. I'm seeing that particular phrase differently but I can also see what you're saying though that it's simply about them not using the 30 day allocation for customers for used pens. I'll reserve argument about this particular phrase for now as I can't fully say that I'm sure about it anymore.

I don't understand it differently. I understand it accurately.

Ok

This instructions also say dispose of the pen after 4 weekly doses. And many of us are not doing that and taking the extra dose.

I agree it's ambiguous and seems to relate largely to the effectiveness being tested up to 30 days after opening.

Could you argue your interpretation of the storage instructions, 'legally'?

Yes (though, as others have said, your cause of action is unclear)

Would you lose if you tried to argue it?

Also yes. Because the language on the leaflet that comes with the medication is unambiguous.

I am a lawyer. You, very clearly, are not.

Lol ok

What legal action do you anticipate being taken about this?

I had thought it was fine to keep in the fridge for longer than 30 days even once opened and was planning to do the same as have taken a 3.75 dose this week rather than 5 and am then going away somewhere extremely hot and will be with prying family. I am going to look up where I read this now.

I have answered that question already. None.

Re: my cause of action, if that is unclear despite my stating atleast twice what it is (including my answer to a question), I do question pp's interpretation of clearly written materials and the ability to state what is ambiguous or not. It also points to a potentially biased interpretation of words based on suspicion? Paranoia? Blind belief? I don't know.

This https://www.medicines.org.uk/emc/files/usermanual.15484.pdf is definitive and not at all ambiguous.

That is the same as the leaflet and doesn't directly mention fridge storage with 'dispose after 30 days', as already stated on the thread.

Storage place is irrelevant for a used pen.

Used pens: Dispose of the pen 30 days after first use.

Only two facts matter - is the pen used, and has it been 30 days since first use. (Assuming > 2 degrees C and < 30 degrees C, of course).

No one has responded to the Asda Online Doctor screenshot and link. Are they talking crap or have I also misunderstood them?

Sorry op, but you are wrong.
The wording is clear, as practically every other poster on this thread has explained.

Op, I’m not sure how many folks need to tell you. It is hugely clear. Inc on the Asda screenshot.

for unopened pens they differentiate between refrigerated and non refrigerated due to storage requirements,
for opened pens they differentiate between refrigerated and non refrigerated due to storage requirements

they do not differentiate for disposal of opened pens, as refrigerated or not, it has to be discarded after thirty days, as such, they do not need to speak specifically to the storage, as both are 30 days.

you seem to think as they do not differentiate it means maybe, just maybe there is some secret over you don’t need to dispose after 30 days of opening.

there is not, it is clear.irrelevant of storage method, once opened it needs to be disposed after 30 days.

this is normal English language usage, if the method of storage does not change the guidance, it doesn’t need to be specified it is both. Because it needs to be disposed of irrelevant of how it was stored

i am a little bemused so so many people are explaining it to you and you still can’t see it, potentially English isn’t your first language. But as you’ve been told by so many people,maybe accept it. Or email your provider and confirm, as it is getting a little repetive now,

I use Asda. I go past the 30 days disposal rule. I do this at my own risk with the clear understanding that Asda and Eli Lilly have very plainly stated that you should not. Yes you can do it, but you are going against the protocols stated by all providers and the manufacturer.

So many people saying it's clear just by their understanding (or not) of what's clear and what's not. Doesn't mean I have to accept them without the request I made to show me a direct statement, which was clear (but seems some people really can't see what is clear).

A few others have said it is not clear, perhaps English isn't their first language too (lol, that was a funny one. I should make my own bingo card).

If it's getting repetitive and tiring, perhaps hiding the thread and moving on is the solution as no one is tied to this thread to keep repeating the same "It is clear" when I've "repetitively" said it is not. I'm also getting tired of the same posters going on and on about it. We disagree, fine. I've said that many times - perhaps accept it and move on instead of trying to force me to accept your opinion.

I store mine in the fridge after first use and use the bonus dose after 30 days. The risk if any is minimal. It is my choice.

It quite clearly gives storage instructions for un-used pens and for used pens. It quite clearly states to discard 30 days after first use.

This is the official, approved leaflet in the pack. It is not ambiguous. There is no room here for your opinion.

Okay thanks for your contribution.

I also do not find this unclear
There is no definite statement 'discard after 30 days' but that is the obvious implication of the statement 'use within 30 days'

It's a really normal instruction to have on a medicine. It's about contamination. Bacteria replicate at a known rate so you can do theoretical calculations of how many would be present after a particular time and clearly 30 days is when they think it might reach a dangerous level if you contaminated it on day 1.

They may not have done any trials to see what actually happens if you keep it past 30 days. It would not be a regulatory requirement to do so. They just cover themselves by stating use by 30 days. It may well be that it is safe but the drug company has no incentive to do a trial to find that out. Why would they?

Lots of people go against the instructions and use it past 30 days. They are doing so at their own risk and if they did get an infection they would not be able to sue the company because it was not used in accordance with instructions. That's all it means.

If you want to use it past 30 days you obviously can but you do it at your own risk and against medical advice so neither the company nor the prescriber is liable if there is any negative consequence for you.

I don't think that a screenshot from one Dr at one online pharmacy will outweigh the manufacturer's instructions in the packet which are the definitive source

Why not ask your own orescriber this question rather than Mumsnet if it really is unclear to you?

No, they are not talking crap. The screen shots refer to storage conditions and length of time permissible at room temperature. You have just not posted the section where it also says discard after 30 days following first use.

This medicine is chemically stable for 18 months, 1 month of which can be at room temperature, whether it’s been opened or not.

Microbiologically, it can be used for 30 days, after which time its preservative will become less effective.

Other posters have taken the position that if they store their in-use pen in the fridge, the risk of microbial growth is acceptably low. This is probably reasonable and rational, but is outside the licensed conditions. No organisation should be recommending use outside its licensed conditions, and I don’t think Asda is. If they were, they would be liable for this advice.

Op, the statement on the instruction leaflet you posted, specifically states discard after 30 days from first use.

i am not sure how this is so unclear to you. I think we all understand you find this confusing, as it doesn’t say discard irrelevant of storage method. But I think you need to accept for everyone else, discard after 30 days from first use is absolute for everyone else.

What the OP seems to want is a statement in the instructions that says:

Used pens: Dispose of the pen 30 days after first use if it has been stored in the fridge.

Plus another statement that says:

Used pens: Dispose of the pen 30 days after first use if it has been stored out of the fridge.

That would make it understandable for the OP.

The majority of people can see that if you had those two instructions, there is logically no need to include the clauses about where to store the pen, as it's clearly irrelevant in this decision context. The only two pertinent facts about when to dispose of the pen are that the pen is used and has been used for 30 days.