Sepiapterin — Active Pharmaceutical Ingredient

Sepiapterin is an active pharmaceutical ingredient found in 1 FDA-approved drug product. Forms: POWDER. Routes: ORAL.

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Sepiapterin (1 brand name, 1 dosage form, 1 route)

Available dosage forms: POWDER.

Routes of administration: ORAL.

Brand Names

  • SEPHIENCE

Indications and Usage

SEPHIENCE is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)-restricted diet.

Contraindications

None.

Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Bleeding [see Warnings and Precautions (5.1)]. Hypophenylalaninemia [see Warnings and Precautions (5.2)].

Mechanism of Action

SEPHIENCE is a precursor of the enzymatic co-factor tetrahydrobiopterin (BH4) which activates PAH.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.