expired Ibrutinib

[Refuashleima]

Hello. I’ve been on Ibrutinib 140mg/day since 2015. My health provider recently started only prescribing one month worth at a time instead of the usual three month supply. As I’m constantly travelling I may be unable to renew my prescription for the next 2 months. I have a sealed Ibrutinib bottle that expired in 2021. Worst case scenario could I safely use this to tide me over until I can get home and pick up my new prescription? Thank you in advance .

[AussieNeil Partner Administrator]

I don't know that you'll be able to get an answer to your question. It's not just humidity exposure to pharmaceuticals that shortens their use by date, but also critically their storage temperature. I know of one study that found that recommended use by dates for a range of tested medication were fairly conservative, but you'll need information specifically for the ibrutinib formulation and only the manufacturer can provide that.

Neil

[LeoPa]

Better than nothing probably

[Astro617]

Can't you just explain your situation and ask your provider to write you a 3 month Rx?

[BayfieldAnnette]

My husband used to get his ibrutinib every 3 months, and then they said there was a shortage, and changed his collection to once a month, and he has to have his blood tests every 3 weeks before he picks up his chemo tablets. You could check with your provider.

[Cheshire2016]

I’d say to never use expired medication.

I used to work in a stability laboratory where we tested medications over time at various storage conditions (to determine/monitor/support/extend the shelf life/expiry dates.)

these will have been established to gain maximum commercial viability, so companies don’t short date these without very good reasons.

Stability studies are required to be performed on marketed products every year, so if a longer expiry was viable, it would have been submitted to the regulatory bodies to change expiry.

Various things happen depending on the drugs, eg. impurities can increase, purity of the active can reduce ( which reduces efficacy of the medication) and many other chemical or physical changes.

[22011 in reply to Cheshire2016]

I worked for a drug company for many years. In the US, the FDA submission for drug approval is usually sent in as soon as the minimum required stability data is available because, as you intimate, it is commercially important to get an approval to go to market as quickly as possible. However, drugs remain on stability testing for many years. As you mentioned, any extension in expiration would have to be submitted to the FDA for approval, a process that can be costly and time consuming, so drug companies rarely do so. Therefore, a drug with a 2-year (normal) expiration date might actually have been on stability testing for 4 years or more and still be viable. The drug isn't "short dated" but rather hasn't been "updated". There's no way to know, and I'm not making a recommendation that I have no standing to make, but when faced with a decision like this I tend to believe that most drugs are viable well after their stated expiration date. BTW, If you were to call the manufacturer they would never give you any information other than what's on the FDA approved label.

[Cheshire2016 in reply to 22011]

The company I worked for did use on-going stability studies to submit longer expiry dates when the data supported this, as more batches on study gave a greater data set.

Companies generally want approval as soon as possible, so will submit on a useable 2 year expiry, rather than wait another year to submit for a 3 year.

So any extra years would be submitted from on going stability data.

There are numerous regulatory bodies to get through depending on territories approved, not just FDA, but although slow was usually considered worth it.

The company I worked for would definitely extend expiry if the data supported it. An extra year of use greatly helps supply chain planning.