We compiled some Frequently Asked Questions (FAQs) to address some questions you may have about NITYR:
FAQs for Healthcare Providers
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 Hereditary Tyrosinemia Type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. NITYR and Orfadin* (nitisinone) capsules are bioequivalent.1 NITYR 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: 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 stable at room temperature between 68°F and 77°F (20°C and 25°C), allowing for excursions between 59°F and 86°F (15°C and 30°C) until its expiry date, and so freeing your patients from having to refrigerate the medication. NITYR tablets are tasteless, very small2 (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 a suspension and taken via an oral syringe (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 bioequivalent to Orfadin* capsules, which means that it has the same efficacy, safety and side effects, and may offer patients and their families greater convenience.1 Further information is available here.
Q: Why should I prescribe NITYR to my patients?
A: NITYR may offer patients greater convenience. NITYR tablets are tasteless, very small2 (baby aspirin sized), do not require refrigeration and can be taken with or without food.
NITYR also offers a 30-Day Free NITYR Program5 for eligible 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 Hereditary Tyrosinemia Type 1 and may offer convenience for patients. NITYR tablets are tasteless, very small2, do not require refrigeration and can be taken with or without food.
Q: How do you administer to infants and other patients with dysphagia?
A: NITYR Tablets are very small2 (baby aspirin sized) and can be swallowed by patients from around 3 years old. However, the ability of the patient to swallow the tablet should be established by their healthcare provider. (A 30-Day Free NITYR Program** is also available).
For those unable to swallow a tablet, NITYR can be converted to a suspension that can be administered as a suspension 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 mixed with 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 patients.§
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-pay 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 Program** 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 Program**, 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 Support 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 Support 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 Support 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 1-800-775-5783. For information about NITYR availability in other countries outside of the US, please contact firstname.lastname@example.org
*Orfadin is a registered trademark licensed by Sobi, Inc. or its affiliates. **Free 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. §Co-pay: For eligible commercially insured patients (up to $15,000 per patient annually). References: 1. Data on file: NIT/02/20. 2. Data on file: NIT/03/18.
* If you select "no" then you will be directed to the Cycle Pharmaceuticals website.