Does gadobutrol expire?
The printed date covers the sealed pack. Once gadobutrol is opened, mixed or diluted, its label sets a second and usually much shorter limit — quoted below, per product.
Shortest limit on any gadobutrol label: 24 hours
“Discard any unused portion 24 hours after puncture of the IBP.”
That applies to the product it is printed on, not to every form of gadobutrol — check which one you have against the list below.
What the labels say
“Discard any unused portion 24 hours after puncture of the IBP.”
On the label for Gadavist · DailyMed
“After the Pharmacy Bulk Package has been opened, gadobutrol injection remains stable for 24 hours at 20°-25°C (68°-77°F).”
On the label for gadobutrol · DailyMed
“The contents of the Pharmacy Bulk Package after initial puncture should be used within 24 hours.”
On the label for gadobutrol · DailyMed
“Discard any unused gadobutrol injection 24 hours after initial puncture of the Imaging Bulk Package.”
On the label for gadobutrol · DailyMed
“Discard any unused Gadobutrol injection 24 hours after initial puncture of the Imaging Bulk Package.”
On the label for Gadobutrol · DailyMed
How the label says to keep gadobutrol
Storage is the other half of the question: the stability behind any date assumes these conditions, and a medicine kept outside them ages faster than the calendar says.
- “16 HOW SUPPLIED/STORAGE AND HANDLING 16.”
- “and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].”
- “and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].”
- “temperature of GADAVIST IBP after the closure has been entered is 20°C to 25°C (68°F to 77°F).”
- “and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).”
- “temperature of gadobutrol injection Imaging Bulk Package after the closure has been entered is 20°C to 25°C (68°F to 77°F).”
- “temperature of Gadobutrol injection Imaging Bulk Package after the closure has been entered is 20°C to 25°C (68°F to 77°F).”
Frequently asked questions
Does gadobutrol expire?
Two different clocks apply and only one of them is the printed date. The date on a sealed pack is the manufacturer's guarantee for the unopened product. Once it is opened, mixed or diluted, the label imposes its own limit — as tight as 24 hours on some gadobutrol products, and that is the number quoted on this page.
Can I still use gadobutrol after the date on the box?
This page cannot tell you that, and nor can any page. The FDA's own shelf-life programme found 88% of tested lots stayed within specification at least a year past expiry — and concluded in the same breath that lot-to-lot variation means this can only be confirmed by testing each lot. What you can check at home is the in-use limit above and whether the product has been stored as the label requires. Ask a pharmacist about a specific pack; they will also dispose of what you no longer need.
Why do different gadobutrol products have different limits?
Because they are different formulations. A suspension that gets mixed with water, a pen that gets carried at room temperature, and a sealed tablet do not behave alike, so each manufacturer's label sets its own limit and each is shown here with the product it belongs to. We never merge them into one number for the molecule.
More on gadobutrol
Quoted from FDA labels for reference, not medical advice, and not a suggestion to use anything past its limit. If you are unsure whether a pack is still good, a pharmacist can tell you and can dispose of it safely.