Sapropterin Pregnancy and Breastfeeding Warnings

Sapropterin is also known as: Kuvan

Sapropterin Pregnancy Warnings

FDA pregnancy category: C Sapropterin should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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 phenylalanine (Phe) levels above 600 mcmol/L were associated with very high rates of neurological, cardiac, facial dysmorphism, and growth anomalies. Dietary control of Phe levels during pregnancy is essential to reduce the rate of Phe-induced teratogenic effects. Women exposed to sapropterin during pregnancy are encouraged to enroll in a patient registry by calling 1-866-906-6100 (USA). 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.

Sapropterin Breastfeeding Warnings

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 sapropterin -Potential side effects in the human milk fed child due to the drug or the mother's underlying condition

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