Drug Index


Mechanism :

Sapropterin is a synthetic form of the cofactor BH4 (tetrahydrobiopterin) for the enzyme phenylalanine hydroxylase.

Indication :

  • To reduce blood phenylalanine levels in patients with hyperphenylalaninemia caused by tetrahydrobiopterin (BH4)-responsive PKU.

Contraindications :

Hypersensitivity to sapropterin or any component of the formulation.

Dosing :

≥1 month:
Initial: 10 to 20 mg/kg PO once daily. Maintenance range: 5 to 20 mg/kg once daily. Adjust after 1 month based on blood phenylalanine levels.

Adverse Effect :

Headache, rhinorrhea, diarrhea, vomiting, pharyngolaryngeal pain, cough, rhinitis.

Interaction :

Levodopa: Sapropterin may enhance the adverse/toxic effect of Levodopa.
Methotrexate: May decrease the serum concentration of Sapropterin.
Phosphodiesterase 5 Inhibitors: Sapropterin may enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors.

Hepatic Dose :

Monitor liver function closely. No dose adjustment recommended.
01/24/2024 10:23:30 Sapropterin
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