Bioequivalence

Change may be concerning for your patients— we understand.

If you are transitioning a patient from another nitisinone to NITYR® (nitisione) Tablets, rest reassured NITYR is bioequivalent to the NTBC your patient has always taken.1 We’re here for your patients to provide continuous support and to ensure a seamless process in transitioning to NITYR.

The recommended initial dose for NITYR and Orfadin®* in the pediatric and adult population is 0.5 mg/kg administered orally twice daily.

Once daily dosing of NITYR is also available for qualified patients on a stable dosage of nitisinone.**

The room-temperature stability of NITYR tablets allows for excursions between 59°F and 86°F (15°C and 30°C) without exceeding impurity limits set by the FDA.

Graph demonstrating Orfadin* 10mg arithmetic mean compared to NITYR 10mg arithmetic mean, show bioequivalence

Graph demonstrating Orfadin®* (nitisinone) capsules 10 mg arithmetic mean compared to NITYR 10 mg arithmetic mean, showing bioequivalence1

Food-effect bioavailability data on NITYR (nitisinone) Tablets 10mg

Food-effect bioavailability data on NITYR (nitisinone) Tablets 10 mg3

Drug product stability – accelerated conditions 104°F, 75% RH5

Drug product stability – accelerated conditions 104°F, 75% RH5

RH=relative humidity.

NITYR Gives Your Patients True Flexibility

Patients and their caregivers especially like NITYR because it may offer greater convenience, while being bioequivalent to the Orfadin®* (nitisinone) capsules they are used to taking: same efficacy, same safety, same side effects.1

Your patients may also find NITYR has a simple administration regimen and supports your patients throughout the treatment journey.

Read patient storiesEnroll your patients

"Knowing that this was the same medication as Orfadin®* gave us confidence."

Carrie: Mother of Ethan
(NITYR patient, 5 years old)

* Orfadin is a registered trademark, licensed by Swedish Orphan Biovitrum AB (publ) and is marketed by Sobi, Inc.

** For patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone

References

1. Data on file: REF-00047
2. Data on file: REF-00004
3. Data on file: REF-00046