* 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

See offer Consultation Guide

See offer Consultation Guide

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NITYR Enrollment Form Safety Information Prescribing Information

Safety Information Prescribing Information

GENERATION LIBERATION

Enhancing the HT-1 Experience for All Life’s Stages

More and more people with Tyrosinemia Type 1 (HT-1) and their caregivers are discovering the independence NITYR brings to their nitisinone medication. NITYR puts your needs first.

Easy to give. Easy to take.

Very small, baby aspirin-sized¹

No refrigeration requirements

No mealtime restrictions

Once-daily dosing*

Flexible administration options for all ages

Why NITYR Try. Compare. Decide.

Patient Stories

Read the stories of patients on their journey and what happened when they discovered NITYR.

Watch Patient Stories

Support Every Step of the Way

Try. Compare. Decide—With the 30-Day Free NITYR Program**

Patient Liaison Support

Patient Nutrition Program^§

Patient Liaison Support Patient Nutrition Program

What I Like about NITYR

Please contact NITYR Patient Liaison Support for more information:
1-800-847-8714

*For patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone. Ask your healthcare provider about taking NITYR once per day.
**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.
^§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
Reference: 1. Data on file NIT/03/18

Why NITYR?

Designed for convenience, NITYR gives patients and their caregivers one less thing to worry about. NITYR liberates patients from the start, with the ...

FAQs

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...

Patient Support

Our Patient Liaison Support and Patient Nutrition Program* helps you get the most of your treatment with NITYR while also promoting good dietary ...

Cycle Pharma

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

US Patients Indications and Important Safety Information

Indications

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 take NITYR if you are allergic to nitisinone or any other ingredients. Tell your healthcare provider about any health problems, and if you are pregnant or planning to become pregnant and/or breastfeeding, before starting treatment.

Warnings and Precautions

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.
• Plasma tyrosine levels above 500 micromol/L may lead to ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia, intellectual disability and developmental delay or painful hyperkeratotic plaques (thickening of the skin) on the soles and palms.
• Your healthcare provider should not adjust NITYR dosage in order to lower the levels of tyrosine in the blood.
• Your healthcare provider will obtain a slit-lamp examination prior to initiating NITYR 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
• You may 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.

Most Common Adverse reactions

The most common adverse reactions (≥1%) in patients with HT-1 taking nitisinone are elevated tyrosine levels, low platelets (thrombocytopenia) or white cells in the blood (leukopenia), and complaints related to the eyes, including conjunctivitis, corneal opacity, inflammation of the cornea, eye pain and extreme sensitivity to light (photophobia), nosebleed (epistaxis), itching (pruritus), skin inflammation (exfoliative dermatitis), rash (maculopapular rash), dry skin and alopecia.

Drug Interactions:

Nitisinone can interfere with the effect of other medicines. Tell your healthcare provider or pharmacist if you are taking, have recently taken or might take any other medicines.

Use in Specific Populations:

Pregnancy: The safety of this medicine has not been studied in pregnancy. Tell your healthcare provider immediately if you become pregnant or planning to become pregnant.
Lactation: The safety of this medicine has not been studied in breastfeeding women. Tell your healthcare provider immediately if you plan on breastfeeding.
Pediatric Use: The safety and effectiveness of nitisinone have been established in pediatric patients for the treatment of HT-1 in combination with dietary restriction of tyrosine and phenylalanine. Use of NITYR in pediatric patients is supported by evidence from one open-label, uncontrolled clinical study conducted with another oral formulation of nitisinone in 207 patients with HT-1 ages 0 to 22 years (median age 9 months)
Geriatric Use: Clinical studies of nitisinone did not include any subjects aged 65 and over. No clinical studies of Nitisinone have been performed in geriatric patients. Your healthcare provider will adjust the dose based on your requirements.

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 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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US-NIT-2100828 . Date of Preparation: July 2021

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