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

The other 2 screenshots

Sorry, here is the revised image with the circled part I mentioned in my first post. I forgot to do that before posting in my first post.

It's not that complicated imo.

1. If unused, the pen can and must be stored in the fridge (2 to 8 degrees C) and can be kept like that until the expiry date on the pen.

2. Once you've started using the pen, then it must be used within 30 days, and can be kept in or out of the fridge, your preference, as long as it is kept under 30 degrees C.

Point (1) is about keeping the active ingredient from degrading and becoming less effective.

Point (2) is about potential contamination and minimising potential bacterial growth once the seal is pierced.

That's it.

Would like a link to your statement from the manufacturer please thanks. As I haven't found that anywhere.

It's on the paper instruction leaflet that comes with the pen, which is written by Lilly as far as I'm aware.

My links and screenshots show exactly what the manufacturer and Asda OD have clearly written which doesn't support "discard after 30 days in or out of the fridge". It sort of reminds me of the 2 year time limit that's supposed to be for Wegovy but was applied to Mounjaro because of vague statements from the manufacturer regarding prescribing time limits for MJ. This one seems to be the same with the room temp and nothing clear on fridge storage but 30 days is being applied to it too.

Yes that is part of the vague statement. It doesn't say if stored in the fridge. It's the general statement. It clearly states discard after 30 days if stored in room temp on their website. If it also meant fridge there is no reason why they wouldn't put fridge as part of the sentence.

I'm not sure what the issue is here, or which part of the instructions are unclear.

Thanks for your contribution though. I simply disagree that it proves to discard used pens after 30 days when stored in the fridge at all times.

Do you mean used or unused fridge storage?

It seem very clear to me that an unused pen must be kept in the fridge.

A used pen can be kept in or out of the fridge, but discarded after 30 days regardless.

It reads like you’re arguing semantics to find a way to justify keeping it longer, when it is utterly clear.

It's a statement for all used pens, regardless of storage method. That's why it's under a 'used pen' heading and not 'used pen at room temperature' heading. The documentation with the actual medicine is entirely clear, whatever other creative reading of support guidance can be done.

@NoBiting I think it is confusing!

It really depends on whether you have opened ie. used the pen.

Once opened/used it has to be discarded within a month.

However unopened/unused it can last up to the expiry date on the pen which may be MONTHS later! I think, though I am not sure, it has to be kept in the fridge though throughout that time, (just to confuse issues)

I hope that makes sense. I think it is very, very unclear myself. (So take no notice of the “it’s obvious” responses).

Look, I'm one of the people who have always reprimanded people about discarding after 30 days! There is no agenda here but looking at something from a certain light since I started looking into it. This is a great loophole. Ask any lawyer - you cannot hold Eli Lilly down with any written text to say that they clearly stated that you can't use it past 30 days if stored in the fridge. That's what I'm arguing. They haven't stated it in black and white - only left it in a grey area. I have been like those who're arguing with me now about this so I understand where you're coming from but until I looked deeply into this, I just didn't question it or see it any differently than what I was told to see.

If it seems clear to you, that's fine. It isn't though and won't hold up in court if someone ever brought it up as proof. It's just for people who're able to look at it objectively to do so and make of it what they will. Nothing more.

People are so rude on MN. I’m not bothering to post on here anymore with these kind of ‘you’re an idiot’ “know-all” type responses. There are Mounjara supportive people on Facebook Mounjara groups. Probably better idea to ask there!

Good luck OP 🍀

But it is in black and white. It's in that screenshot for the medication insert. It says used pens must be discarded after 30 days. If it only applied to room temperature jabs it would say that but it doesn't. It is under the 'used pens' heading along with other stuff that very clearly applies to used pens regardless of storage.

That’s because irrelevant of storage method it has to be discarded after 30 days. They don’t need to state refrigerated or not.

And I'm pretty sure the documentation of the actual medication saying used pens should be disposed of after 30 days is exactly the kind of thing that would be proof in court!

A used pen is a pen that has been used, that's the only way they are defining it in that document.

It’s just like some ham I have in my fridge. The use by date is two weeks away, so I could keep it unopened and use it safely at any time up to that date. But if I open it today, it needs to be eaten within two days of opening, even though it won’t have reached the use-by date at that point. I don’t see another way of interpreting it.

Why would you look for ways to take risks with a substance you inject into your body?

It says ‘used pens must be discarded after 30 days’. There is no need to state ‘both refrigerated and unrefrigerated’, because it applies to both.

Yes this!

Although I have used mine beyond 30 days and have been fine 😂

Eye drops must always be discarded 30 days after opening. They contain preservatives which are only effective for 30 days. MJ also contains a preservative. I assume, therefore, that the principle is the same - the issue is the fall in efficacy of the preservative after 30 days from opening rather than the efficacy of the tirzepatide or the storage temperature. I do agree, however, that the guidance could be more explicit about this so that debates like this wouldn't be necessary. I think people would then be as reluctant to inject a substance potentially full of bacteria into their bellies as they would to squirt it in their eyes.

@NoBiting you are asking really good questions here imho. I have tried - and failed - to access any trial data/scientific data that shows what happens to the medicine within the pen after 30 days ie does efficacy wane and if so how fast? Does the preservative or a carrier fail? Is there an excess of introduced bacteria and how does that affect patients in vivo? I am very sceptical that this data has not been published because it wouldn’t help sell more pens - I don’t think anything magical happens on day 31 and generally medicines have a bit of tolerance around these dates.
But obviously it’s a risk to use it after that time without evidence. What is clear is that the efficacy data, side effect data and licence are all based on discarding it after 30 days. So probably better to be cautious I guess.

Most medicines don’t publish this though, it’s perfectly normal.

I don't really understand why people are having such difficulty with comprehension. The instructions are quite clear. Do you do this with other prescribed drugs too? I find it very odd.