Does dactinomycin expire?
The printed date covers the sealed pack. Once dactinomycin is opened, mixed or diluted, its label sets a second and usually much shorter limit — quoted below, per product.
Shortest limit on any dactinomycin label: 4 hours
“Discard after 4 hours.”
That applies to the product it is printed on, not to every form of dactinomycin — check which one you have against the list below.
What the labels say
“Discard after 4 hours.”
On the label for Dactinomycin · DailyMed
How the label says to keep dactinomycin
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 Dactinomycin for Injection, USP for intravenous use is an amorphous yellow to orange powder.”
- “Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).”
- “Protect from light and humidity.”
- “Store at room temperature for no more than 4 hours from reconstitution to completion of injection or infusion.”
- “16 HOW SUPPLIED/STORAGE AND HANDLING Dactinomycin for injection, USP is a lyophilized powder.”
- “Store at 20º to 25ºC (68º to 77ºF); [see USP Controlled Room Temperature].”
- “16 HOW SUPPLIED/STORAGE AND HANDLING Dactinomycin for Injection USP for intravenous use is supplied as a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial.”
- “Store at 20 to 25ºC (68 to 77ºF); excursions permitted between 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature].”
Frequently asked questions
Does dactinomycin 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 4 hours on some dactinomycin products, and that is the number quoted on this page.
Can I still use dactinomycin 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 dactinomycin 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 dactinomycin
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.