Health Canada has approved an updated version of the NITISINONE TABLETS’ Product Monograph

November 19th 2019

November 19th, 2019 – We are pleased to announce that Health Canada has approved an updated version of the NITISINONE TABLETS’ Product Monograph (PM) including an improvement to the administration procedure for infants using an oral syringe.

NITISINONE TABLETS is a prescription only medicine indicated for the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

HT-1 is a rare genetic disease that is unusually common in Quebec, particularly in the Saguenay-Lac-Saint-Jean region, affecting children from birth. Untreated, it leads to serious health consequences that can include childhood liver transplants or early death.

Cycle Pharmaceutical’s NITISINONE TABLETS was approved by Health Canada in November 2016, and it was the first HT-1 treatment to be recommended by the Institut National d’Excellence en Santé et Services Sociaux Quebec (INESSS) passing its rigorous evaluation in June 2017.

NITISINONE TABLETS are small and tasteless tablets (baby aspirin sized) for all ages. With the update to the PM, patients and caregivers can now create as suspension using an oral syringe with a cap and administering to patients until they are able to swallow the small tablets. The suspension created can be kept for up to 24 hours before administration which may provide further convenience.

Cycle’s tablets are also approved by the European Medicines Agency (EMA) in Europe and it is currently prescribed in several countries and regions around the world such as U.S., Middle East, Australia, Latin America, South East Asia and South Africa. Registration conditions differ internationally.

NITISINONE TABLETS have an established safety profile with warnings and precautions as follows:

Warning and Precautions: Endocrine and Metabolism: Elevated plasma tyrosine levels. Hematologic: Leukopenia and thromboclytopenia. Hepatic/Biliary/Pancreatic: Liver status should be assessed regularly through liver function tests. Neurologic: Variable degrees of intellectual disability and developmental delay have been observed in HT-1 patients treated with nitisinone. In patients treated with nitisinone who exhibit a change in neurologic status, a clinical laboratory assessment including plasma tyrosine should be performed. Ophthalmologic: Ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia have been reported in patients treated with nitisinone. Patients who develop photophobia, eye pain, or signs of inflammation such as redness, swelling, or burning of the eyes during treatment with NITISINONE TABLETS should undergo slit-lamp re-examination and immediate measurement of plasma tyrosine concentration.
Contraindications: Patients who are hypersensitive to nitisinone or to any ingredient in the formulation or component of the container; Mothers receiving NITISINONE TABLETS should not breast feed. Common Adverse Reactions: The most common adverse reactions (≥1%) reported in patients treated with nitisinone (NTBC) are: Eye Disorders: conjunctivitis, corneal opacity, keratitis, photophobia, blepharitis and eye pain. Blood and lymphatic System Disorders: thrombocytopenia, leukopenia and granulocytopenia. Skin and subcutaneous tissue disorders: pruritis, exfoliative dermatitis and maculopapular rash. Investigations: elevated tyrosine levels.

The Canadian Product Monograph and Patient Medication Information Leaflet are available here: www.nitisinonetablets.com

GL-0030 (November 2019)