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Adverse Event Reporting details can be found at the bottom of this page
ORFADIN® is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinaemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
ORFADIN® is also indicated for the treatment of adult patients with Alkaptonuria (AKU).
Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with hereditary tyrosinaemia type 1 (HT-1) and/ or Alkaptonuria (AKU).
Hereditary tyrosinaemia type 1
an ultra-rare inherited metabolic disorder
Hereditary tyrosinaemia type 1 (HT-1) affects one newborn in 100,000 and is caused by a defect in the genetic coding for the enzyme responsible for breaking down the amino acid tyrosine, fumarylacetoacetate hydrolase (FAH). Untreated, HT-1 is ultimately fatal.1,2
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard (for United Kingdom) and www.hpra.ie (for Republic of Ireland). Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at [email protected] or Telephone +44 (0) 800 111 4754
PP-23058