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 advice from the medical service that prescribes my MJ is that the pen can be used longer than 30 days!

I’m in Scandinavia, a cautious part of the world.

They say that ‘although the manufacturer recommends discarding after 30 days, it is our patients’ experience that the drug remains effective after several months of use and this is also supported by the manufacturer’s own trial data. But it’s up to you how long you use it.’

I will certainly use all 8 of the doses in my first pen.

Scientifically it is relevant where it is stored as refrigeration will reduce bacterial multiplication so it would stand to reason that it could be stored for longer in a fridge than out

However legally if there is no distinction made in the instructions then the company is not liable for any negative consequence of your unregulated use and nor is your prescriber or supplier (unless they advise you to go against the manufacturers instructions they would make themselves liable so they will not do that)

Drug companies obviously do want to make money from their products. They are not charities. They want to make money for their shareholders and minimise the risk of being sued so usually their advice will be very conservative. There is nothing particularly sinister in that but there is noting in it for them to 'clarify' the in fridge storage advice. They are never going to advise taking a risk to make it last longer so it is pointless to keep googling trying to find some back up as there is zero reason for the drug company to do this so they won't.

This is not accurate, many things,refrigerated have to be discarded a certain amount of time after opening. Many food stuffs would be a good example. You have a long life on it, but once opened you need to consume within 2 days as an example.

the reason for this is plenty bacteria multiplies and grows irrelevant of storage. On top of this, no one knows the reason why the drug needs to be disposed of but it is likely not just bacteria, but certain components, which ensure the drugs safety deteriorate.

however you’re right,if someone deliberately chooses to use medicine after the advice is to dispose, then only they are responsible.

I don’t think the op would stand a chance in court arguing that she didn’t feel the statement discard after 30 days was absolute, and she wanted it to say irrelevant of storage method.

The PP’s statement is accurate, actually. Mounjaro is preserved so at room temperature the preservative alone is inhibiting microbial growth, whereas in the fridge the temperature is also inhibiting growth.

The 30 day in-use shelf life is taking into account both the risk of microbial growth and also the accelerated chemical degradation at room temperature.

You’re 100% right about where responsibility lies for using a medicine outside its licensed instructions though.

The problem is, not everyone has enough information to be able to do their own risk assessment.

Would I use paracetamol tablets that expired in 2019? Certainly. Would I use eye drops that have been open for longer than the instructions say? Absolutely not.

They are also vanishingly unlikely to get regulatory approval to extend the in-use expiry of an injectable medicine.

Completely agree. I would do the same re: paracetamol tablets and eye drops

I don’t think I would use an injectable medication past its use by date because if it was contaminated the consequences could be serious.

DH won't eat anything past the use by but I do if I've weighed up the chances of it going off but the worst that can happen is food poisoning which is not something I am very scared of.

Christ on a bike

To be fair, I’d probably wing it with refrigerated Mounjaro for a fortnight maybe because it’s just subcutaneous. But I wouldn’t advise anyone to follow my example. 😁

It's a personal risk assessment. I have some experience in this area. Firstly I do think that pharmaceutical companies / legislation are always very cautious. Presumably both because they want absolute safety and efficacy and also to increase profits. Do you remember when epi pens were in short supply and they issued a statement saying you could extend the expiry date by 6 months from what was on the label? It just shows there's a massive grey area. Likewise when they were rolling out the covid vaccines the Moderna one in the first year had to be fridged apart from a few hours when open and giving it, and this made it much harder to organise giving it. A year later when they had more data they allowed it to be at room temperature for days at a time which totally changed the logistics and made it much easier.

Personally if I was struggling financially I would absolutely make a mounjaro last longer by a number of weeks /up until the expiry date for fridged unopened pens. What's the worst that happens?

It's a subcutaneous injection so if it happened to have got contaminated / infected within the pen that may cause an infection under the skin. Which to be honest seems very unlikely to happen anyhow especially if you use an alcohol wipe on your skin first for every injection (ie you minimise any chance of bugs getting into your pen). And a subcut infection isn't awful anyhow (ie it's not serious compared to if you were proposing injecting something a bit suspect intravenously which I would definitely never do).

Secondly it may just not be effective if it's had too long out the fridge. I find this hard to believe if you're just taking it out for ten minutes a week to give the injection as the pen would likely remain fairly cold if you don't take it out for many minutes. Similar to how the supply chain has to be cold but it's understandable that there will be a couple of minutes here and there where it isn't in a fridge eg when moved from fridged van to a fridge in the pharmacy and that is still accepted as part of the cold chain. But there remains a risk it may be less effective over time.

As I said I think it depends on your personal risk assessment and also your finances!

Ps I'm not even on mounjaro though my OH has used it earlier this year.

Do you remember when epi pens were in short supply and they issued a statement saying you could extend the expiry date by 6 months from what was on the label

yes but they will have extensively tested before they did that, and they will do it each time.

we do something similar, all a consumer will see is the expiry extended. What they don’t see is the testing done to confirm,and simply as it is done once, doesn’t mean we can just do it again.

Do you remember when epi pens were in short supply and they issued a statement saying you could extend the expiry date by 6 months from what was on the label?

@jellyjellyinmybelly The same thing actually happened to Mounjaro pens. I think it was the 2.5mg pens that were supposed to expire 9/24 but were extended up to a few months or so.

Also in the US, their pens are supposed to be discarded after 21 days of use as opposed to our 30 days. Some people say they've been told 6 weeks or 8 weeks too but I don't know.

My worry is people storing it in a domestic fridge with food isn't the same as a clinical drug fridge so I feel there may be a risk of cross contamination. Sure a subcut injection isn't as bad as IV but I was worrying about cellulitis or at the worst necrotising fasciitis. But maybe that's just me.

Everyone has their own threshold but it's important to realise that you have no comeback if something goes wrong whilst you are using it off licence and outside medical advice.

The extended expiry date related to unused pens so a different risk.

The US pens are a different type to UK ones so completely different.

I would be more concerned about what happens to the medication itself as its preservative wears off, and its active ingredients degrade.

The preservative used in this case prevents microbial growth and has no effect on the chemical stability of the drug.

So are you saying there isn’t any natural degradation of the substance itself? It remains stable and efficacious indefinitely?

The extended expiry date related to unused pens so a different risk.

That wasn't the point I was making to the pp. I was simply stating something similar. However, to your point, the pens had their expiry date as 9/24. Some of us received the pens from some providers in the same month 9/24, so used or unused, it would have supposedly been a big risk. However, we received the pens with notes to say the expiry date has been extended so we should disregard the 9/24 written on the box. It didn't feel good to have an "expired" (but extended) pen to start using for 4+ weeks. The extended date was to say it's okay to use them in September and beyond till the extended date, even though the original unused (and therefore used because if it's expired as unused, it's automatically expired to be used as well - not sure what differentiation you were trying to make there) expiry date is Sept. We used it because the manufacturers said so. That was it.

The US pens are a different type to UK ones so completely different.

Nowhere did I say otherwise. I'm stating another fact to another pp that has nothing to do with how similar our pens are or not, nor was I making any other point (as you seem to assume) than what I wrote.

I am not. What I am saying is that the preservative in Mounjaro doesn’t have any effect on its chemical degradation rate.

It (and pretty much all medicines) chemically degrades gradually over time, and degradation is faster the warmer it is. After 18 months, including up to 1 month at room temperature, it still contains over 95% of its original content, so is OK. After that point the content may be below an acceptable level, and gets worse the longer it’s stored.

This is so interesting - could you please provide a link to this advice (happy to read non-English) 😀

The point about whether the drug remains effective after 30 days is not in question. The point is whether the preservative system - which is added to the 4 dose Kwikpen version of Mounjaro and is not needed in a single dose eg USA version - remains effective after 30 days.

However, if you could please ask your provider for a copy of the quoted manufacturer's trial data that would be enormously interesting for this thread.

@ThePure for the fridge issue, the main difference between a clinical fridge in a hospital or pharmacy and a home fridge is actually all to do with maintaining stable temperatures between 2 and 8 degrees C. A medical fridge must have a validated thermometer eg one that displays outside the fridge but reads inside the fridge with a little wire and alarms if the temp is out of range. And a log must be kept of the temps to prove that they're in range.
Yes you're right it's not good to let an open injection touch food but that's easily solved by keeping the mounjaro pen in packaging and away from touching food.

Re epipen being unopened yes that's true but it does give you an idea of the greyness of these decisions! Plus the moderna vaccine example. With more testing products can be proven to last longer but it would cost the drug company money to prove that, and then they'd sell less drug, so it's not worth their while to.

Cellulitis and necrotising fasciitis bugs are often from your skin surface eg group A streptococcus and are pushed under the skin by the needle. So it's always a tiny risk whether the drug is new or old that you're injecting. As I previously said, I think by cleaning the skin with an alcohol wipe every time the pen is used it minimises any chance of bugs.

Personal risk assessment but I think there are waaayyyyy more risky things most people do every day than inject mounjaro kept in the fridge for more than 30 days!

I also had one of the extended expiry pens.

The extension of the expiry date had no impact on the advice to use within 30 days of first use.

Anyway if you still think there is any lack of clarity perhaps email Eli Lilly.

@NoBiting and anyone else who wants to know whether you can safely keep/use a opened pen after 30 days if kept in the refrigerator, or who otherwise finds the instruction ambiguous -

I emailed Eli Lilly directly with this specific question yesterday with a link to this thread. This is their response in full with only my name removed:

Dear Ms XXX

Thank you for your enquiry about the storage of the Mounjaro KwikPen.

The Instructions for Use provides full instructions for storage of used, and unused, pens and clearly states the pen must be disposed of 30 days after first use. This applies to used pens stored at room temperature or those stored in the fridge.

The following is the information on storage in the Instructions for Use:

Storing your Mounjaro KwikPen

Unused pens:
• Store unused pens in the refrigerator between 2°C to 8°C.
• Unused pens may be used until the expiration date printed on the label if the pen has been kept in the refrigerator.
• Do not freeze your pen. Throw away (discard) the pen if it has been frozen.

Used pens:
• You may store your used pen at room temperature up to 30°C after your injection.
• Keep away from heat.
• Keep your pen and needles out of the sight and reach of children.
• Dispose of the pen 30 days after first use.
• Dispose of the pen after receiving 4 weekly doses.

The Instructions for Use are provided with each Mounjaro KwikPen, and are also available at https://www.medicines.org.uk/emc/product/15481/usermanual#about-medicine

Please discuss any questions about the storage of the Mounjaro with a pharmacist, or with another healthcare professional.

We hope this information is helpful.

Yours sincerely

UK and RoI Medical Information
Eli Lilly and Company Limited
Lilly House, Basing View, Basingstoke, Hampshire, RG21 4FA

Tel: +44 1256 315000
[email protected] | https://www.lilly.com/uk/  | www.lillymedical.co.uk

Up-to-date Lilly SPCs can be found at: www.medicines.org.uk (GB), www.emcmedicines.com/en-GB/northernireland/ or www.medicines.ie (Ireland)

Eli Lilly and Company Limited, a company incorporated in England under company registration number 284 385 and having its registered office at Lilly House, Basing View, Basingstoke, Hampshire, RG21 4FA

For the record - and I bet a million £s that this won't be widely disseminated by the tiktokkers or Facebookers - this is the relevant line (my emphasis):

"The Instructions for Use provides full instructions for storage of used, and unused, pens and clearly states the pen must be disposed of 30 days after first use. This applies to used pens stored at room temperature or those stored in the fridge."

If anyone still has any doubts then they also can contact Eli Lilly through their email address which is clearly displayed on their UK website [email protected]