Sepiapterin Pregnancy and Breastfeeding Warnings

Brand names: Sephience

Medically reviewed by Drugs.com. Last updated on Sep 16, 2025.

Sepiapterin Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Uncontrolled blood phenylalanine (Phe) levels before and during pregnancy are associated with increased risk of adverse pregnancy outcomes and fetal adverse effects.
-During the 3 months prior to conception and during pregnancy, blood Phe levels should be maintained between 120 and 360 mcmol/L to reduce the risk of hyperphenylalaninemia-induced fetal adverse effects.

Animal studies have failed to reveal evidence of embryofetal toxicity. In pregnant rats and rabbits administered this drug via oral gavage during organogenesis, no maternal or embryofetal developmental toxicities were observed at doses up to 1000 mg/kg/day, 9-fold (rats) and 6-fold (rabbits) the human exposure at the maximum recommended human dose. There are no controlled data in human pregnancy.

Available data from a collaborative study in pregnant women with phenylketonuria showed uncontrolled Phe levels greater than 600 mcmol/L are associated with an increased risk for major birth defects (including microcephaly, major cardiac malformations), intrauterine fetal growth retardation, and future intellectual disability with low intelligence quotient (IQ).

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Sepiapterin Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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