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NITYR

NITYR

The nitisinone tablet for all life stages

Patients Healthcare Professionals

Important Safety Information

Do not prescribe NITYR to patients allergic to nitisinone or any other ingredients. Patients should report problems, and if they are pregnant or planning to become pregnant, 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 the dosage of NITYR in order to lower the levels of tyrosine in the blood

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 clot)
Your healthcare professional will monitor platelet and white blood cell counts, and will adjust your medication accordingly
If you have a question about your dosage, or if you experience any of the symptoms explained above, please speak to your healthcare professional.

Adverse Reactions

The most common adverse reactions (>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.

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

Patients should keep NITYR and all medicines out of reach of children.

For more detailed information, please refer to the full prescribing information, which can be found at www.nityr.us/pi

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Enrollment Form Download
Free Trial Form Download

NITYR Patient Support Program: 1-800-847-8714 Medical information team: 1-855-831-5413 Free trial support team: 1-844-767-5865

Resources

Enrollment form
Prescribing information
Instructions for use
NITYR patient initiation brochure

Terms Privacy Acceptable Use

US-0070. Date of Preparation: June 2018

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