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Sapropterin Pregnancy and Breastfeeding Warnings

Sapropterin is also known as: Kuvan

Medically reviewed on May 28, 2018

Sapropterin Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; caution is recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Comments: This drug should be considered only if dietary restriction of phenylalanine (Phe) is ineffective in reducing blood Phe levels.

Animal studies have failed to reveal clear evidence of teratogenic activity; however, in a rabbit study, an increase (not statistically significant) in the incidence of holoprosencephaly occurred with high doses. There are no controlled data in human pregnancy.

Uncontrolled Phe levels above 600 mcmol/L in pregnant women were associated with very high rates of neurological, cardiac, facial dysmorphism, and growth anomalies in their infants. Dietary control of Phe levels during pregnancy is essential to reduce the rate of Phe-induced teratogenic effects.

US: To monitor the outcomes of pregnant women exposed to this drug, a patient registry has been established. For additional information: 1-866-906-6100

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Sapropterin Breastfeeding Warnings

AU, UK: Use is not recommended.
US: Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk:
-IV: Yes
-Oral: No

The following should be considered:
-The developmental and health benefits of human milk feeding
-The mother's clinical need for this drug
-Potential side effects in the human milk fed child due to the drug or the mother's underlying condition

See references

References for pregnancy information

  1. "Product Information. Kuvan (sapropterin)." BioMarin Pharmaceutical Inc, Novato, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Kuvan (sapropterin)." BioMarin Pharmaceutical Inc, Novato, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.