Orfadin label

Orfadin

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Uses

Orfadin(R) capsules (nitisinone) are indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1).

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History

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Other Information

Orfadin contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1).

Nitisinone occurs as white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.

Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione, and the structural formula is:

Structure of nitisinone.

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Orfadin Manufacturers

  • Rare Disease Therapeutics, Inc.
    Orfadin | Rare Disease Therapeutics, Inc.
    No Recall

    Orfadin | Rare Disease Therapeutics, Inc.

    Orfadin | Rare Disease Therapeutics, Inc.
    2.1 Dosage

    The recommended dose of Orfadin is 1 to 2 mg/kg divided into two daily doses. The initial dose is 1 mg/kg/day divided for morning and evening administration. Treatment with Orfadin should be initiated by a physician experienced in the treatment of HT-1.

    The dose of Orfadin may be adjusted in each patient. In patients whose erythrocyte PBG-synthase activity and urine 5-ALA and urine succinylacetone are not normalized within one month after the start of Orfadin treatment, the Orfadin dose may be increased to 1.5 mg/kg/day. In patients receiving 1.5 mg/kg/day, whose erythrocyte PBG-synthase activity and urine 5-ALA and urine succinylacetone remain elevated and whose plasma succinylacetone is not normalized after three months, the dose may be increased to up a maximum dose of 2 mg/kg/day.

    If plasma nitisinone concentration, plasma succinylacetone, urine 5-ALA and erythrocyte PBG-synthase activity are not available, clinical laboratory assessments should include urine succinyl acetone, liver function tests, alpha fetoprotein, and serum tyrosine and phenylalanine level. During initiation of therapy and during acute exacerbations, it may be necessary to follow more closely all available biochemical parameters [see Warnings and Precautions (5)].

  • Swedish Orphan Biovitrum Ab (Publ)
    Orfadin | Swedish Orphan Biovitrum Ab (publ)
    No Recall

    Orfadin | Swedish Orphan Biovitrum Ab (publ)

    Orfadin | Swedish Orphan Biovitrum Ab (publ)
    2.1 Dosage

    The recommended dose of ORFADIN is 1 to 2 mg/kg divided into two daily doses. The initial dose is 1 mg/kg/day divided for morning and evening administration.

    Treatment with ORFADIN should be initiated by a physician experienced in the treatment of HT-1. The dose of ORFADIN may be adjusted in each patient. In patients whose erythrocyte PBG-synthase activity and urine 5-ALA and urine succinylacetone are not normalized within one month after the start of ORFADIN treatment, the ORFADIN dose may be increased to 1.5 mg/kg/day. In patients receiving 1.5 mg/kg/day, whose erythrocyte PBG-synthase activity and urine 5-ALA and urine succinylacetone remain elevated and whose plasma succinylacetone is not normalized after three months, the dose may be increased to up a maximum dose of 2 mg/kg/day.

    If plasma nitisinone concentration, plasma succinylacetone, urine 5-ALA and erythrocyte PBG-synthase activity are not available, clinical laboratory assessments should include urine succinylacetone, liver function tests, alpha-fetoprotein, and serum tyrosine and phenylalanine level. During initiation of therapy and during acute exacerbations, it may be necessary to follow more closely all available biochemical parameters [see Warnings and Precautions (5)].

    2.2 Administration

    ORFADIN should be taken at least one hour before or at least two hours after a meal, since food effect is unknown. For young children, ORFADIN capsules may be opened and the contents suspended in a small amount of water immediately before use.

    Physicians should counsel patients and their parents or caregivers of the need to maintain dietary restriction of tyrosine and phenylalanine when taking ORFADIN to treat hereditary tyrosinemia type 1.

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