Does nitisinone expire?
The printed date covers the sealed pack. Once nitisinone is opened, mixed or diluted, its label sets a second and usually much shorter limit — quoted below, per product.
Shortest limit on any nitisinone label: 2 hours
“Discard after 2 hours.”
That applies to the product it is printed on, not to every form of nitisinone — check which one you have against the list below.
What the labels say
“Discard after 2 hours.”
On the label for NITYR · DailyMed
“Discard after 24 hours.”
On the label for NITYR · DailyMed
“If not used within 45 days, discard ORFADIN capsules.”
On the label for ORFADIN · DailyMed
“If not used within 45 days, discard Nitisinone Capsules.”
On the label for Nitisinone · DailyMed
“If not used within 60 days, discard unused portion.”
On the label for ORFADIN · DailyMed
How the label says to keep nitisinone
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 Capsules: White capsules marked in black with "NTBC" and identified as 2 mg, 5 mg, 10 mg or 20 mg strengths of nitisinone.”
- “Store refrigerated at 2° to 8°C (36° to 46°F).”
- “Alternatively, patients/caregivers may store ORFADIN capsules at room temperature up to 25°C (77°F) for up to 45 days.”
- “Store refrigerated at 2°C to 8°C (36°F to 46°F) prior to first use.”
- “After first opening, store the product at room temperature (up to 25°C (77°F)) for up to 60 days.”
- “Store the bottle in the refrigerator prior to first use.”
- “Store the bottle at room temperature (not above 25°C).”
- “and Handling Store NITYR tablets at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].”
Frequently asked questions
Does nitisinone 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 2 hours on some nitisinone products, and that is the number quoted on this page.
Can I still use nitisinone 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 nitisinone 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 nitisinone
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.