NITYR® (nitisinone) Tablets
What is NITYR?
NITYR is an FDA-approved tablet indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Designed with convenience in mind, NITYR may give patients and their caregivers one less thing to worry about.
At Cycle, we know that supporting people with rare diseases is about more than just the medicine. That’s why we created Cycle Vita, delivering individualized product support with NITYR, every step of the way.
More and more people with HT-1 and their caregivers are discovering the independence NITYR can bring to their nitisinone medicine.
NITYR product support available to you
Start your NITYR enrollment here
Download, complete and fax a PDF
The first 24hrs
Your Cycle Vita team will quickly get to work with your insurance provider to help you understand your coverage.
We will coordinate seamlessly between different parties, such as insurance companies, doctors, and pharmacists to meet your prior authorization and documentation requirements.
We will route your NITYR therapy to the appropriate specialty pharmacy and follow-up to ensure swift shipment of your medication.
Additional assistance, when required, throughout your journey
In some cases, an appeal may be needed. Where this is the case, our experienced team will work with your insurer and doctor to understand and overcome any NITYR reimbursement gaps.
Co-Pay Assistance*
A $0 co-pay is available for eligible commercially insured patients.* This program will help cover the cost of insurance co-pays for NITYR, up to the program maximum, for those who are eligible. Please contact our Access Specialists to find out more about this and other programs that may be available to you (such as Quick Start, Bridge Program etc.).
Our proactive team will remind your doctor when your NITYR prescription needs to be renewed, in a timely manner, to ensure an uninterrupted supply of your therapy.
We provide product support to help you manage every aspect of your NITYR therapeutic routine, such as clinical education and 1-to-1 administration training either at home or in-clinic.
Translation services are available on request.
What is HT-1?
Hereditary Tyrosinemia Type 1 (HT-1) is an inherited autosomal recessive genetic condition. When a person is born with tyrosinemia type 1 their body is missing the enzymes to break down the amino acid tyrosine in food. Without this enzyme, a dangerous buildup of toxic substances in the body can occur. This in turn can lead to serious liver and kidney problems, making early diagnosis and management essential.
Following a low protein diet is a key part of living with HT-1. Published medical guidelines recommend patients with HT-1 follow a low-protein diet to avoid complications associated with elevated plasma tyrosine levels. 1 However, eating properly while following a low-protein diet can be challenging.
As part of the NITYR Experience, eligible patients can utilize the Patient Nutrition Program, which provides access to a Registered Dietitian to support you in following the nutrition goals set and agreed upon by your healthcare team. Please contact our Access Specialists to find out more about this and other programs that may be available to you.
In the United States, HT-1 is primarily diagnosed at birth. Newborn screening typically involves a heel stick blood test. However, a positive screening result may not be definitive. Your healthcare provider will generally order additional blood and urine tests to confirm the diagnosis. Early testing gives the opportunity to start treating you baby as early as possible, minimizing the risk of further complications.
Remember, you’re not alone. The Cycle Vita team is here to support you for life.
Resources
Footnote
*$0 co-pay for eligible commercially insured patients within specified limits and relevant terms and conditions.
Cycle Vita™ is a trademark of Cycle Pharmaceuticals in the United States. NITYR® is a registered trademark of Cycle Pharmaceuticals in the United States.
References
- Chinsky JM, Singh R, Ficicioglu C, van Karnebeek CDM, Grompe M, Mitchell G, Waisbren S, Gucsavas-Calikoglu M, Wasserstein MP, Coakley K, Scott CR, Diagnosis and treatment of tyrosinemia type I: a US and Canadian consensus group review and recommendations. Genet Med. 2017 Dec;19(12):1-16. doi: 10.1038/gim.2017.101