We compiled some Frequently Asked Questions (FAQs) to address some questions you may have about NITYR:
FAQs for Healthcare Professionals
Q: What’s NITYR and what strengths are available?
A: NITYR (nitisinone) is a new formulation of nitisinone (NTBC) that is prescribed to treat patients with Tyrosinemia Type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. NITYR and Orfadin* (nitisinone) capsules are bioequivalent1. NITYR tablets comes in 2 mg, 5 mg, and 10 mg tablets.
Q: Is NITYR also NTBC?
A: Yes, NITYR contains the active ingredient nitisinone. NTBC is an abbreviation for nitisinone and the two terms mean the same thing.
Q. What is Cycle Pharmaceuticals response to the COVID-19 pandemic?
A. Given the unprecedented COVID-19 lockdown that shuts down patient access to wellbeing facilities that may seriously impact the health of HT-1 patients, Cycle has developed a COVID-19 Response Wellbeing Program2 for a limited period of time and only for eligible patients with HT-1.
The COVID-19 Response Wellbeing Program includes a Low Protein Food Program and an Online Fitness Program.
The Low-Protein Diet Food Program2 has been created in partnership with with Ajinomoto Cambrooke that eligible HT-1 patients can redeem against medical nutrition for all products available at Cambrooke’s website.
The Online Fitness Program2 has been created in partnership with the leading fitness organizations in partnership with My Gym and Fit Factory, to provide eligible HT-1 patients of all ages with an on-line live program that they can join to support a healthy exercise routine from home, while most groups classes and gyms are closed across the country.
For more information on these programs, click here to learn more.
Q: Do the tablets have any flavor?
A: NITYR tablets are tasteless.
Q: Who manufactures NITYR?
A: Cycle Pharmaceuticals manufactures NITYR (nitisinone) tablets in Switzerland.
Q: How is NITYR different from other nitisinone in the market?
A: NITYR is stable3 at room temperature between 68° and 77°F (20° and 25°C), allowing for excursions between 59° and 86°F (15° and 30°C) until its expiry date, and so freeing your patients from having to refrigerate the medication. It has a shelf life of 36 months (3 years). NITYR tablets are tasteless, small4 (baby aspirin sized), easy to swallow and can be taken with or without food at any time of the day.
For younger patients or patients that can’t swallow tablets, NITYR can also be converted to an oral suspension (see video and supporting materials here) or can be crushed and mixed with applesauce. See full instructions for use here.
Q: Is NITYR bioequivalent to Orfadin* (nitisinone) capsules?
A: Yes, clinical trials have demonstrated NITYR is bioequivalent1 to Orfadin capsules, which means that it has the same efficacy, safety and side effects, and may offer patients and their families greater convenience. Further information is available here.
Q: What do you mean by “improved stability”?
A: NITYR tablets were designed to be more convenient for your patients because they can be stored at room temperature between 68° and 77°F (20° to 25°C), allowing for excursions between 59° and 86°F (15° and 30°C), with less likelihood of the formation of potentially toxic impurities.
Even in accelerated conditions (40°C; 104°F and 75% RH) and over 6 months, NITYR does not surpass the impurity limits established by the FDA. See graph here for more details.
Q: Why should I prescribe NITYR to my patients?
Q: How do I prescribe NITYR and where can I find the enrollment form?
Q: Why would any of my patients be interested in NITYR?
A: NITYR is an option for the treatment of HT-1 and may offer both convenience for patients and a price advantage. NITYR tablets are tasteless, very small, do not require refrigeration and can be taken with or without food. The COVID-19 Response Wellbeing Program2 may offer benefits and enable access to wider range of medical foods and formulas.
Q: How do you administer to infants and other patients with dysphagia?
A: NITYR Tablets are very small4 (baby aspirin sized) and can be swallowed by patients from 3 years old. However, the ability of the patient to swallow the tablet should be established (a 30-Day Free NITYR Program5 is available).
For those unable to swallow a tablet, NITYR can be converted to a suspension that can be administered via an oral syringe and stored for up to 24 hours at room temperature before use. If your patient can swallow soft food, NITYR Tablets can also be crushed and added to applesauce. Further information and a short video are available here.
Q: Do you have a patient support program?
A: Yes, the NITYR Patient Support Program is available to patients. The patient support team is available so your patients can gain advice and support with access to a pharmacist when they need help or have any questions. Home delivery and proactive refills are also provided, making this process more convenient for your patients as well. We also offer $0 co-pay for eligible patients6.
For more information please refer patients to www.nityr.us or call 1-800-847-8714.
Q: Do you have a $0 co-pay?
A: As part of Cycle’s dedication to providing NITYR to patients in an accessible and affordable manner, we provide a $0 co-pay6 to eligible commercially insured patients (up to $15,000 per patient annually). For more information, please contact our NITYR Patient Support Program on 1-800-847-8714
Q: How can I find out if NITYR is less expensive for any of my patients?
A: The NITYR Patient Support Program can complete a full benefits investigation for your patients. Please complete the enrollment form and send it back to the support team. You and your patients will be informed of the results from the investigation to support your decision making. Patients undergoing the 30-Day Free NITYR Program5 will also receive the information on their benefits investigation. Enrollment forms can be faxed to 1-800-842-5163.
Q: Can patients get free samples of NITYR to try?
A: There is a 30-Day Free NITYR Program5, that will give your patients an opportunity to decide if NITYR is right for them.
During the 30 day program, your patient will receive calls from our NITYR Patient Liaison Services Team including an initial call to discuss NITYR and how to administer the medication. If you or your patients have any questions before, during or after the program, our Patient Liaison Services is available on 1-800-775-5783.
More information on the 30-Day Free Program can be found here.
Q: Where can I call if I have more questions about NITYR?
A: Please contact the Patient Liaison Services on 1-800-775-5783, or contact our Medical Information team on 1-855-831-5413.
Q: I would like to see a NITYR medical representative – how do I arrange a visit?
A: For appointments and patient materials in the US, please contact 1-800-903-1793. For information about NITYR availability in other countries outside of the US, please contact firstname.lastname@example.org
1Data on file: NIT/02/20. 2 Wellbeing Program (Low-Protein Food Program and Online Fitness Program): Subject to terms and conditions and eligibility criteria. This program is for eligible commercially insured patients only. Not available for government-insured patients and subject to other federal and state law. Terms, Conditions and eligibility criteria is available at www.nityr.us/offertcs.3 Data on file: NIT/01/20. 4 Data on file: NIT/03/18. 5Free NITYR Program: Patients can try NITYR for 30 days, one time, for free, as long as their doctor prescribes it. Subject to terms and conditions, eligibility criteria, and other federal and state law. Terms and Conditions and eligibility criteria are available at www.nityr.us/offertcs. 6 Co-pay: For eligible commercially insured patients (up to $15,000 per patient annually). *Orfadin is a registered trademark licensed by Sobi, Inc. or its affiliates. Cambrooke is a registered trademark of Ajinomoto Cambrooke, Inc. My Gym is a registered trademark of Gym Consulting LLC. Fit Factory is a registered trademark of Fit Factory LLC.
* If you select "no" then you will be directed to the Cycle Pharmaceuticals website.