Does trastuzumab expire?
The printed date covers the sealed pack. Once trastuzumab is opened, mixed or diluted, its label sets a second and usually much shorter limit — quoted below, per product.
Shortest limit on any trastuzumab label: 24 hours
“If not used immediately, store the reconstituted Herceptin solution for up to 24 hours at 2°C to 8°C (36°F to 46°F) ; discard any unused Herceptin after 24 hours.”
That applies to the product it is printed on, not to every form of trastuzumab — check which one you have against the list below.
What the labels say
“If not used immediately, store the reconstituted Herceptin solution for up to 24 hours at 2°C to 8°C (36°F to 46°F) ; discard any unused Herceptin after 24 hours.”
On the label for Herceptin · DailyMed
“Discard after 24 hours.”
On the label for Herceptin · DailyMed
“If not used immediately, store the reconstituted HERZUMA solution for up to 24 hours at 2°C to 8°C (36°F to 46°F); discard any unused HERZUMA after 24 hours.”
On the label for HERZUMA · DailyMed
“If not used immediately, store the reconstituted Ontruzant solution for up to 24 hours at 2° to 8°C (36° to 46°F); discard any unused Ontruzant after 24 hours.”
On the label for Ontruzant · DailyMed
“Store reconstituted HERZUMA in the refrigerator at 2°C to 8°C (36°F to 46°F); discard unused HERZUMA after 28 days.”
On the label for HERZUMA · DailyMed
“Store reconstituted Ontruzant in the refrigerator at 2° to 8°C (36° to 46°F) ; discard unused Ontruzant after 28 days.”
On the label for Ontruzant · DailyMed
How the label says to keep trastuzumab
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.
- “Store Herceptin vials in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution.”
- “If not used immediately, store the reconstituted Herceptin solution for up to 24 hours at 2°C to 8°C (36°F to 46°F) ; discard any unused Herceptin after 24 hours.”
- “Do not freeze .”
- “This storage time is additional to the time allowed for the reconstituted vials.”
- “Store HERZUMA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution.”
- “Store reconstituted HERZUMA in the refrigerator at 2°C to 8°C (36°F to 46°F); discard unused HERZUMA after 28 days.”
- “If not used immediately, store the reconstituted HERZUMA solution for up to 24 hours at 2°C to 8°C (36°F to 46°F); discard any unused HERZUMA after 24 hours.”
- “Store Ontruzant vials in the refrigerator at 2° to 8°C (36° to 46°F) until time of reconstitution.”
Frequently asked questions
Does trastuzumab 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 trastuzumab products, and that is the number quoted on this page.
Can I still use trastuzumab 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 trastuzumab 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 trastuzumab
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.