If you have questions about NITYR, you are not alone. We have compiled some Frequently Asked Questions (FAQs) to help, but if you have any other questions then get in touch with the NITYR Patient Liaison Services.
Q: What is NITYR?
A: NITYR (nitisinone) Tablets are a new option for the treatment of HT-1. NITYR is bioequivalent1 to Orfadin* and contains the same nitisinone (NTBC) you are used to, but NITYR has been formulated in a way that can provide greater convenience for patients and their families.
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?
Q: Do the tablets have any flavor?
A: NITYR is tasteless.
Q: Who manufactures NITYR?
A: Cycle Pharmaceuticals manufactures NITYR in Switzerland.
Q: How do you deliver this medication?
A: The medication is delivered directly to a location of your choice and comes with a convenient proactive refill program.
Q: Can I get a free sample of NITYR to try?
A: The 30-Day Free NITYR Program3 gives you the opportunity to decide if NITYR is right for you and your family.
During the Program, you will receive calls from our NITYR Patient Liaison Services Team, including an initial call to discuss NITYR and explain how to administer the medication. If you have any questions before, during or after the Program, our Nityr Patient Liaison Services is available on 1-800-775-5783.
The Free Program won’t stop your current deliveries of Orfadin*.
For more information on the 30-Day Free NITYR Program click here.
Q: Do I need to keep NITYR in the fridge?
A: No, NITYR is stable4 at room temperature between 68° and 77°F (20° to 25°C), allowing for excursions between 59° and 86°F (15° and 30°C) until its expiry date. It has a shelf life of 36 months (3 years).
Q: Are there any adverse reactions associated with taking NITYR?
A: NITYR has the same efficacy and safety profile as your current nitisinone (NTBC) treatment.
The most common adverse reactions (>1%) to taking NITYR are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia.
Q: How do you administer NITYR to small babies and toddlers?
A: NITYR tablets are very small5 (baby aspirin sized) and can be easily swallowed by patients from 3 years old. However, the ability of the patient to swallow the tablet should be established by your HCP (a 30-Day Free Program is available3).
For those unable to swallow a tablet, NITYR can be converted to a suspension that can be administered via an oral syringe. The suspension can be stored at room temperature for up to 24 hours before use. If your child can swallow soft food, NITYR tablets can also be crushed and added to applesauce. Further information and a short video are available here.
Q: From what age can children swallow NITYR tablets?
A: Generally, children aged 3 years and older can swallow NITYR tablets (tablets are baby aspirin sized5). However, check with your healthcare professional before administering NITYR tablets to young children (a 30-Day Free Program is available3).
Children under 3 years old can take NITYR by creating a suspension using an oral syringe (watch video here) or by crushing the tablets and mixing them with applesauce. The suspension can be stored at room temperature for up to 24 hours before use. Our Patient Liaison Services Team can provide training, oral syringes and tablet crushers free of charge and give you tips on how to teach your child to swallow NITYR Tablets. Please call 1-800-775-5783.
Q: Does NITYR have a patient support program?
A: Yes, we provide the NITYR Patient Support Program for US patients and caregivers. You can call the Patient Support Team and gain advice and support from a specialist pharmacist when you need help or have any questions. The program also includes delivery of your medication to your home and proactive refills. For more information call 1-800-847-8714 or visit here.
Q: What other support do you offer to patients?
As part of the Low-Protein Food Program you will receive a $400 monthly contribution to spend on Cambrooke Therapeutics’ specialist foods.
For questions on this program, call the Cambrooke team on 1-866-456-9776.
Q: What do I do if I miss a dose?
A: If you forget a dose, take the next dose as planned. Do not take a double dose to make up for a forgotten dose. Contact your healthcare professional or the NITYR Patient Support Program3 on 1-800-847-8714 for further advice.
Q: What can I or my child eat during treatment with NITYR?
A: Your child should follow a low-protein diet and avoid foods and drinks that contain phenylalanine or tyrosine. You should work with your healthcare professional and consult a metabolic dietician skilled in helping people manage amino acid disorders for specific dietary instructions. Dietitian consultations are provided free of charge through the NITYR Patient Support Program. A COVID-19 Response Wellbeing Program2 is available to eligible patients.
Q: My son/daughter has no symptoms and has been feeling good for a while, can I stop the medication?
A: No. HT-1 is a lifelong condition and it’s important to maintain recommended medication and dietary routines to lower the risk of adverse health outcomes.
Q: How does NITYR work?
A: NITYR Tablets contain nitisinone, which prevents the build-up of toxic substances which cause severe liver and kidney problems in patients with HT-1. Patients still need to follow a low-protein diet, restricting the intake of phenylalanine and tyrosine to control tyrosine levels in the body.
Q: I am not in the United States, how can I receive NITYR?
A: For NITYR availability in other countries please contact: firstname.lastname@example.org
Additional FAQs for Patients Moving to NITYR
Q: Why should I move to NITYR? And how do I do it?
A: NITYR (nitisinone) Tablets may be more convenient for patients and their families. Moving to NITYR is easy to do and a 30-Day Free NITYR Program3 is available. Discuss with your healthcare professional. A new Consultation Guide is available to help patients and caregivers navigate questions with their HCP about choosing NITYR.
Q: How is NITYR different from the nitisinone I’ve been prescribed before?
A: NITYR (nitisinone) tablets are bioequivalent1 to Orfadin* (nitisinone) capsules, which means that it has the same efficacy, safety and side effects, and may offer patients and their families greater convenience.
NITYR is also stable4 at room temperature between 68° to 77°F (20° to 25°C), allowing for excursions between 59° and 86°F (15° and 30°C), until its expiry date, freeing you from having to refrigerate the medication. It has a shelf life of 36 months (3 years).
NITYR tablets are tasteless and very small5 (baby aspirin sized) and come in 2 mg, 5 mg and 10 mg tablets. NITYR can be taken with or without food, and comes with a price advantage and a COVID-19 Response Wellbeing Program2.
Q: Is NITYR the same as Orfadin* (nitisinone) capsules?
A: NITYR is bioequivalent1 to Orfadin*, which means that it has the same efficacy, safety and side effects, and may offer patients and their families greater convenience.
Q: Are the adverse reactions different from Orfadin* capsules?
A: Because NITYR (nitisinone) Tablets are bioequivalent1 to Orfadin* capsules, NITYR has the same efficacy, safety and adverse reactions.
Q: What do you mean by ‘improved stability’?
A: Improved stability 4 refers to how long NITYR can be stored at room temperature for (up to 77°F/25°C), allowing for excursions between 59° and 86°F (15° and 30°C), until its expiry date. It has a shelf life of 3 years. Because of this improved stability you do not need to refrigerate NITYR.
Q: Will NITYR cost me more than my current nitisinone medication?
A: NITYR should not cost you more and the COVID-19 Response Wellbeing Program2 may help with the out of pocket expenses. Our team can make a full benefit investigation to tell you straight away how much NITYR will cost. We also offer $0 Co-pay for eligible patients7.
Talk to your healthcare professional and ask them to complete a 30-Day Free NITYR Program3 enrollment form. The results will help you with the decision.
Q: Will there be adverse reactions associated with moving from my current nitisinone to NITYR?
A: No, patients who move to NITYR are not expected to experience any new adverse reactions. The most common adverse reactions for nitisinone (>1%) are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash and alopecia. Click here for full adverse events and prescribing information.
1 Data 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 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. 4Data on file:NIT/01/20 5 Data on file: NIT/03/18.6 Data on file: NIT/01/20 7$0 co-pay for eligible commercially insured patients (up to $15,000 per year per patient). *Orfadin is a registered trademark licensed by Sobi, Inc. or its affiliates. Cambrooke Therapeutics 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.