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.
Graph demonstrating Orfadin* 10mg arithmetic mean compared to NITYR 10mg arithmetic mean, show bioequivalence1
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.**
Food-effect bioavailability data on NITYR (nitisinone) Tablets 10mg3
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.
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 simpler administration regimen and supports you and your patients throughout the treatment journey.
"Knowing that is 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.