Sapropterin Pregnancy and Breastfeeding Warnings

Sapropterin is also known as: Kuvan

Sapropterin Pregnancy Warnings

Sapropterin has been assigned to pregnancy category C by the FDA. Animal studies failed to reveal clear evidence of teratogenic activity. However, in one animal teratogenicity study there was an increase (not statistically significant) in the incidence of holoprosencephaly. There are no controlled data in human pregnancy. Sapropterin should only be given during pregnancy when benefits outweigh risks.

Women who are exposed to sapropterin during pregnancy are encouraged to enroll in the sapropterin patient registry.

Sapropterin Breastfeeding Warnings

An animal study has reported sapropterin to be excreted into milk following intravenous administration, but not excreted into milk following oral administration.

There are no data on the excretion of sapropterin into human milk. Because of the potential for serious adverse reactions in nursing infants from sapropterin and because of the potential for tumorigenicity shown for sapropterin in an animal carcinogenicity study, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

See Also...

• sapropterin Consumer Information
• Pregnancy Support Group
• FDA Pregnancy Categories
• Medicine use during Pregnancy
• Medicine use while Breastfeeding
• Safe Medications during Breastfeeding

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