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Safety InformationPrescribing Information

COVID-19 Response Wellbeing Program1

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 Program for a limited period of time and only for eligible patients with HT-1.

Cycle partnered with Ajinomoto Cambrooke, Inc., a global leader in therapeutic medical nutrition, to create the Low-Protein Food Program. As part of this Program, eligible patients will receive a $400 monthly contribution towards the purchasing of protein formulas and low protein foods.

Under the current circumstances, Cycle understands that patients find that most group classes and gyms are closed across the country. With this in mind, the COVID-19 Response Wellbeing Program also includes an Online Fitness Program developed with My Gym and Fit Factory, to ensure that patients can maintain a healthy lifestyle during the lockdown. Eligible patients will receive a monthly membership which gives access to a number of online activities.

For further details about the Low-Protein Food Program please contact Ajinomoto Cambrooke, Inc. on 866-456-9776, opt. 2.

For more information about the COVID-19 Response Wellbeing Program, specifically the Online Fitness Program, please contact the Patient Liaison Services at 1-800-775-5783.

  • Redeeming your $400 monthly contribution

    If you are an eligible patient, redeeming your monthly contribution is an easy process, simply:

    1. Take a picture of the packing slip that comes with your NITYR medication, making sure that the text is in focus and can be easily read, and send the photo to info@cambrooke.com
    2. Go to Ajinomoto Cambrooke, Inc. and choose the products you would like to spend your $400 montly contribution on, from delicious metabolic food formulas containing Tylactin™ with GMP, to low protein pasta, pizza and snacks.
    3. Call the Ajinomoto Cambrooke, Inc. Customer Service Team on 866-456-9776 and select option 2 to place your order.
  • Experience NITYR

    If you are still considering if NITYR is right for you and your family, click here to find out more about our 30-Day Free NITYR Program.2

    If you are considering NITYR, speak to your HCP, your dietitian or your clinic today – you don’t need to wait until your next appointment. To help you get the most out of the discussion, we’ve gathered some common questions to ask your HCP. Simply follow the link to download the guide here.
     

1Wellbeing 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 here. 2 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 here. My Gym is a registered trademark of Gym Consulting LLC. Cambrooke is a registered trademark of Ajinomoto Cambrooke, Inc. Fit Factory is a registered trademark of Fit Factory LLC.

This website is for education purposes only. It is not intended to be, and should not be used as, a substitute for medical advice.

Important Safety Information

Indication and Usage

NITYR® (nitisinone) Tablets is a synthetic reversible inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase indicated for use as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1).

Important Safety Information

Do not take NITYR if you are allergic to nitisinone or any other ingredients. Tell your healthcare professional about any health problems, and if you are pregnant or planning to become pregnant and/or breastfeeding, before starting treatment.

The warnings and precautions that come with NITYR include:

Increased levels of plasma tyrosine, eye symptoms, developmental delay and skin changes:

  • Inadequate restriction of tyrosine and phenylalanine intake can result in elevations of plasma tyrosine.
  • At plasma tyrosine levels above 500 micromol/L, symptoms can occur including intellectual disability and developmental delay or painful hyperkeratotic plaques (thickening of the skin) on the soles and palms.
  • Do not adjust NITYR dosage in order to lower the levels of tyrosine in the blood.
  • Your healthcare provider may obtain a slit-lamp examination prior to treatment, regularly during treatment and may reexamine you if you develop symptoms or if your tyrosine levels are above 500 micromol/L.

Changes in blood profile

  • Patients can develop leukopenia (reduction in the number of white blood cells, which form part of the immune system) and severe thrombocytopenia (abnormally low levels of platelets, which help the blood to clot).
  • Your healthcare provider will monitor platelet and white blood cell counts, and will adjust your medication accordingly.

Adverse reactions

The most common adverse reactions to taking NITYR are elevated tyrosine levels, low platelets or white cells in the blood, and complaints related to the eyes, including conjunctivitis, corneal opacity, inflammation of the cornea, eye pain and extreme sensitivity to light.

If you have a question about your dosage, or if you experience any of the symptoms explained above, please speak to your healthcare provider.

Keep NITYR and all medicines out of reach of children.

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

If you get any side effects, talk to your healthcare provider. This includes possible side effects not listed in this brochure. You may also report side effects directly by calling Cycle Pharmaceuticals at 1-855-831-5413 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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