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 or search for MHRA Yellow Card in the Google Play or Apple App
Store (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