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

[NoBiting]

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

I also don’t understand why some seem so desperate to be able to use it for longer than 30 days from opening. Is it for money saving reasons? If the medication was being prescribed on the NHS would this much analysis be going into the wording?

@PromoJoJo 5 doses fits within the 30 days, injections on day 1, 8, 15, 22 and 29.

8 weeks... well you'd have to recognise that you are risking bacterial infection and ineffectiveness of the active ingredient. It's not something I'd causally recommend to others as unproblematic and risk free.

This. Was reading it and thinking what instructions say and it was

Everyone needs to make their own personal risk assessment and be aware that past 30 days is breaking manufacturer protocol. Personally 2.5 is working really well for me still at week 8. I'm using a 5mg pen counting 30 clicks. It's in the fridge apart from the 60 seconds when I use it each week. I'm using medi wipes and new needles and washing my hands. If it lasts 8 weeks it lasts 8 weeks. I believe the antibacterial ingredient, hygiene procedures and refrigeration mean the risk is pretty minimal. If you believe otherwise then bin it after 30 days.

The instructions are crystal clear unless you either 1) choose to try to misunderstand them, 2) have issues with comprehension.

If you choose not to follow them and take the risk, based on ropey facebook posts from unverified, unqualified sources then at least own it and don't try to blame "vague" instructions. You are just making yourself look a bit silly.

If you have comprehension issues, which might lead to you not understanding any instructions of this prescription only medication perhaps contact your provider for additional support.

@ThatSchoolOfficeLady
As I said earlier, the 30day limit is nothing to do with the efficacy of tirzepatide but the efficacy of the preservative. You sound like you're employing very good hygiene but many people don't, I'm sure. As long as people are aware of the potential bacterial infection risks, there's nothing more to be said I'd have thought, except I wish EL would make this risk clearer in their guidance, instead of leaving people to assume it's about profiteering.

I used one of my pens for 7 weeks. Kept it in the fridge all the time. No problem at all.
I will be doing it with my next pen too.

Where does that belief come from (other than social media) to extend the usage by such a significant length? I understand stretching it a couple of days over 30, but doubling it is reckless.

Have you factored in if the medication retains its chemical stability after 30 days once exposed to air and the oxidation process starts, exposed to light and moisture in a domestic environment. It isn't just bacteria and hygiene that needs to be considered, the chemical structure of Mounjaro (or any medication, especially in liquid form) starts to change as soon as the laboratory seal is broken and changes in that structure could result in harmful compounds, we all know peptide drugs are sensitive to their environment and need to be handled and stored carefully to maintain chemical integrity.

The changes in that structure, or the formation of chemical byproduct, the impact in your body's organs repeatedly having to process them, might not be immediately apparent.

Out of date prescription only antibiotics can degrade into compounds that are harmful to your kidneys, why anyone would take a similar unknown risk with prescription only peptides amazes me.

Ok, you've done it and I am happy for you it seems ok and hope it continues to be. But you are deluding yourself if you don't think you are playing russian roulette with a needle by doubling the intended use of the medication.

Did you feel power for the first time writing this nasty post or is it your usual character? Tell me what in my posts warranted such personal insults. As you appear to be someone who can't post without being emotional, I doubt you are one to listen to.

Furthermore, that you managed to conclude what I choose to do (which is actually wrong because i don't plan on using it past 30 days but unlike you, I can have objective discussions regardless of my personal stance. I even mentioned in my post that you clearly didn't read or didn't comprehend that I won't be recommending it to anyone either) and claim it's based on "ropey facebook posts from unverified, unqualified sources" shows that either 1) You didn't read my posts fully and just got what you wanted from it or 2) you read but ironically didn't comprehend anything from it. If you didn't see clearly that my argument is mainly based on clearly attached screenshots and links from both Eli Lilly and Asda Online Doctor websites which aren't unverified or unqualified (and i actually pointed out the unverified screenshots so you're saying nothing new), then you must have been looking in the mirror as you wrote your despicable post.

Anyway, I won't be responding anymore to a nasty individual like you and anyone like you who obviously couldn't fight the compulsion to insult even after I asked in my OP, and whose only source of feeling powerful in life is posting personal attacks and making nasty, condescending, insulting posts instead of making objective points on mumsnet. You obviously cannot have a healthy discussion or disagree like a normal, rational, civilised human being. That's much worse than anything you think you've shat out in your post about me.

Thanks all for your contributions. I suppose i should make it clear that I'm looking at this from a legal standpoint as opposed to medical. The writings have 'legal team' written all over it. Like a pp seems to understand, Eli Lilly should make an explicit statement regarding this, which they haven't despite some people claiming they have.

From a legal standpoint, there's no direct statement here about pen should be in the fridge for no more than 30 days, like these ones (Let me attach them again). None. No one has shown any evidence to that at all. What is written is up for interpretation as they've cleverly written things. It's as "clear" as the legal team wants it to be and if you understand how that works, you'll know it's not an oversight.

If someone is in doubt, perhaps you could email Eli Lilly and ask them to state directly if a pen should be discarded after 30 days of being open/used while being in the fridge. The answer is either yes or no but I bet they'll come back (if they do at all) with a 'politician's speech' that won't directly answer the question.

If you still think it's clear, we'll agree to disagree.

(Ironically, I didn't think this needs to be said but for the posters who clearly assumed this, this thread or my posts have no indication whatsoever about what I intend to do with my Mounjaro pens besides what I stated in my last post. I'm only trying to discuss an issue I've come across and decided to look up. It's okay to disagree).

But it literally says in the insert that used pens should be discarded after 30 days. The actual leaflet that comes inside the box. A PP posted the pic and I've checked mine and it's the same. It's got a heading of 'used pens'. The other stuff in that list applies to all used pens too, except the one section where it says it may be stored at room temperature after opening. None of the other items on the list have anything to do how it is stored. The heading is 'used pens', therefore it applies to any pen that is used, as it is written.

I don't think it could be much clearer on the insert personally.

I understand what you're trying to get at, but it has explicitly stated it on the insert, there's no real way to misunderstand the leaflet that comes with the medication unless on purpose. Used pens is entirely clear and obvious - it applies to a pen that is used. No other variables. A used pen is a used pen.

What legal issue are you anticipating here that would require a court case?

The instructions in the UK patient leaflet are absolutely clear, and that's what Lilly would refer to if anyone had any cause to question that in a legal setting.

I still don't see what part of the instructions you think are unclear. A used pen can be kept in or out of the fridge for 30 days before it must be discarded. An unused pen must be kept in the fridge and can be kept until its expiry date. That is abundantly clear from the leaflet instructions. Can you say why you disagree with what I've said here?

Please show me where fridge storage is written here and compare it to my screenshots that you can easily verify from their websites? As I said, it's as clear as the legal team want it to be. It's left to interpretation and for the user to assume what they mean instead of being explicit, which isn't an oversight. They very clearly always state room temp when talking about 30 days storage but fridge storage is always somewhere, anywhere around, somewhere near or another paragraph or sentence. It's just something to notice. If it's not there to you, that's fine.

Never once have they used it fully in the same sentence. You may think it's arguing "semantics" but oftentimes legally, that's how you win or lose a case. (No, I'm not anticipating a legal case. It's a hypothetical discussion from a legal standpoint).

Here it is again. It's clear that the bullets points are referring to 'used pens'. It doesn't need to specify fridge/room temp because a used pen is a used pen regardless. If it was relevant there would be separate bullet points.

Now there is a discussion to be had about safety, obviously at 31 days it doesn't turn toxic and kill you. But that's the limit they have put on for infection control/reduction of efficacy reasons. I'm sure plenty of people have and do use it longer when they are titrating down or maintaining with no ill effects, but 30 days is currently the risk level the pharmaceutical company are comfortable with.

Side note, in America they have a different kwikpen often which is individual weekly doses, not four in one, so some info online relates to that.

But it doesn't need to say fridge storage! Because storage method is irrelevant for used pens. That's the whole point. It says 'used pens' because it doesn't matter where it's stored when it comes to the bullet points.

Answer me this: is a pen you have used a 'used pen'?

If you agree it is indeed a used pen, then the heading of 'used pens' applies to your pen.

If you don't think the pen you have used is a 'used pen' then that's a whole new ball game.

In one of the screenshots, they have "the 30 day room temp exposure allowance refers to used pen..."

30 day room temp exposure allowance? Not room and fridge? They didn't need to specify fridge in here and leaflets because it would take longer to write?

We'll agree to disagree. They legally do need to state it if it is indeed true just like they've stated everything else. It's simply assumption or wishful thinking or something else to think they don't have to state it. You're essentially putting words in their mouth by saying what you think they mean instead of looking at what is written and isn't written.

My opinion is that they cannot directly state it because they cannot legally back it up. I'll change my opinion if they do.

If the pen is used it must be discarded after 30 days irrespective of storage method.

That's from your own posts OP

I'll like to see where "irrespective of storage methods" or to that effect was written as I haven't seen that.

I'm going to attach Asda's screenshot again as it actually seems a bit clearer than Eli Lilly. I'm only sticking to Eli lilly since they're the manufacturers. But I'll like to know if it's clear to some people that they mean 'discard after 30 days of used pen when refrigerated too' on Asda's website, when they're clearly talking about unrefrigerated/out of the fridge used pens.

It's not like the medication transforms into battery acid on day 31 🙄

All the evidence, biology of peptides and loads of easily findable on-line anecdotes suggest if left in the fridge and handled very cleanly it will be safe and effective for months. The manufacturers have only tested its safety and effectiveness for 30 days and so will not recommend beyond that date. Any use after 30 days from opening is done at your own risk. You pays your money and you makes your choices.

What legal issue do you anticipate here? Lilly being sued for some reason, due to issuing allegedly unclear instructions and therefore potentially causing harm to someone? Or something else?

This refers to how pharmacies handle pens. They are not allowed to use any of the 30-day room temperature days. Ergo, they have to keep it at fridge temperatures at all times.

Also, it's not about fridge or nor fridge. It's about used or unused. Unused = must be in fridge, can keep up to expiry date. Used = may be at room temp, discard after 30 days regardless. No other information is needed and that is utterly clear and easy to understand. And it's what is written on the info leaflet as per the image posted here.