* 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/offerstcs

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Safety InformationPrescribing Information

New Nutrition Support Launched to Benefit HCPs and NITYR patients

March 18th, 2021

In addition to our live virtual community events, Tyrosinemia Connections, we have implemented two new nutrition support programs to help the HT-1 community in these unprecedented times.

  • Assistance for patients in adherence to the nutrition plan designed and established by your clinic’s doctor or RD protocol – the Patient Nutrition Program 1
  • Support for RDs in their understanding of Hereditary Tyrosinemia Type 1 (HT-1) nutritional management – Tyrosinemia 1:1 Dietitian Support2
    Both these programs recognize the critical role of a carefully tailored low-protein diet in a complete treatment plan for patients with HT-1, delivered by Registered Dietitians/Nutritionists (RDs) and supported by organizations such as AND, GMDI and SIMD.

    Both these programs do not add, change, replace or eliminate the nutrition plan given by the doctor or RD.

Patient Nutrition Program

We understand that it can be challenging for patients to retain the nutrition information received during clinic visits and calls. By working with your clinic’s dietitian to only reinforce the nutrition plan created by the doctor or RD, our new Patient Nutrition Program aims to overcome some of the challenges and, with their consent, help your patients and their families to meet the nutrition goals designed by the doctor and/or RD.

The sessions will be led by Angela Kurtz, MS, RD, CDN (Clinical Metabolic Director), and will include discussion topics tailored to meet your patient’s individual nutrition goals designed by your team and will be shared in advance. The discussion will be delivered through 30-minute telephone or video calls with patients and/or caregivers, with the overall goal of supporting the nutrition care designed and delivered by your clinic. This program is available to patients undergoing treatment with a low protein diet and NITYR® (nitisinone) Tablets.

In addition, we have extended the Patient Nutrition Program to commercially insured patients on the 30-Day Free NITYR Program3 , where patients can try the NITYR Experience without interruptions to their current nitisinone medication.

Please do discuss within your clinic if the Patient Nutrition Program is well-suited to any of your patients with HT-1.

Tyrosinemia 1:1 Dietitian Support

Furthermore, we are introducing Tyrosinemia 1:1 Dietitian Support to provide specialized dietitians with a resource to address this rare disorder and further advance understanding of HT-1 nutritional management.
This product support is designed for all Registered Dietitians/Nutritionists who have become metabolic dietitians in the past two years, or those who have not treated a patient with HT-1 before, provided through telephone or video calls.

Find out more about the 30-Day Free NITYR Program here. To find out more information about the Patient Nutrition Program or Tyrosinemia 1:1 Dietitian Support contact Angela Kurtz at 1-646-234-7576 or email Angela.Kurtz@cyclepharma.com.

References:
1. Patient Nutrition Program: Subject to terms and conditions and eligibility criteria. This program is for patients with a valid prescription for NITYR issued by their physician or other HCP, or commercially insured patients on the 30-Day Free NITYR Program, and is subject to other federal and state law. Terms, conditions and eligibility criteria are available at www.nityr.us/offerstcs. 2. Tyrosinemia 1:1 Dietitian Support: Subject to terms and conditions and eligibility criteria. This program is for registered dietitians and nutritionists who have become metabolic dietitians in the past two years or have not treated a patient with HT-1 before, and is subject to other federal and state law. Terms, conditions and eligibility criteria are available at www.nityr.us/offerstcs. 3. 30-Day 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/offerstcs.

Important Safety Information

Indication and Usage

NITYR® (nitisinone) Tablets are a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase 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.

Important Safety Information

Do not prescribe NITYR to patients allergic to nitisinone or any other ingredients.
Use in Pregnancy: Limited available data with nitisinone use in pregnant women.
Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or from the underlying maternal condition.

Warnings and Precautions

Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques:

  • Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine, which at levels above 500 micromol/L can result in ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia, intellectual disability and developmental delay or painful hyperkeratotic plaques on the soles and palms.
  • Do not adjust the NITYR dosage in order to lower the plasma tyrosine concentration.
  • Perform baseline ophthalmologic examination including slit-lamp examination prior to initiating treatment, and regularly during treatment. Reexamine patients if symptoms develop or tyrosine levels are > 500 micromol/L.
  • Perform a clinical laboratory assessment, including plasma tyrosine levels, in patients with an abrupt change in neurologic status.

Changes in blood profile
Patients can develop leukopenia and severe thrombocytopenia: Monitor platelet and white blood cell counts.

Adverse reactions

The most common adverse reactions (≥1%) in patients with HT-1 taking nitisinone 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.

Drug interactions

  • Nitisinone is a moderate CYP2C9 inhibitor, a weak CYP2E1 inducer and an inhibitor of OAT1/OAT3.
  • Potential clinical impact of concomitant administration with CYP2C9 Substrates: Increased systemic exposure of co-administered drugs metabolized by CYP2C9. Intervention: reduce the dosage of the of
    co-administered drugs metabolized by CYP2C9 by half. Additional dosage adjustments may be needed to maintain therapeutic drug concentrations for narrow therapeutic index drugs.
  • Potential clinical impact of concomitant administration with OAT1/OAT3 Substrates: Increased exposure of these co-administered drugs; monitor for potential adverse reactions.

For more detailed information, please refer to the full Prescribing Information at www.nityr.us/pi.

To report suspected adverse reactions, you may contact Cycle Pharmaceuticals at 1-855-831-5413 or you may also contact FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch