Sepiapterin

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).

Prescribing label

Selected manufacturer label information, organised into consistent sections by Sofidex. This source is written for healthcare professionals; ask your pharmacist to explain instructions that are unclear. Read the full label at DailyMed ↗

Drug facts

Used for: 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).

What it is used for

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.

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

Increased Bleeding.
Hypophenylalaninemia.

Who should not take it

None.

Storing it

Storage and Handling

Store SEPHIENCE at room temperature between 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F).

Store SEPHIENCE liquid or soft food mixture either refrigerated or at controlled room temperature.

Cite this page

NLM: sofidex [Internet]. Daloreum; c2026. Sepiapterin; [reviewed 2026 Aug 3; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/sepiapterin
APA 7th: sofidex. (2026, August 3). Sepiapterin. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/sepiapterin
AMA 11th: Sepiapterin. sofidex. Reviewed August 3, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/sepiapterin

The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.