Caution is recommended; benefit should outweigh risk

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: Limited data on use of this drug in pregnant women is insufficient to inform a drug-associated risk; women with type I Gaucher disease have an increased risk of spontaneous abortion if disease symptoms are not treated and controlled pre-conception and during pregnancy.

Comment: Pregnancy may exacerbate existing type 1 Gaucher disease symptoms or result in new disease manifestations.

Animal studies have failed to reveal evidence of embryo-fetal toxicity with doses 5 times the recommended human dose. An increased risk of spontaneous abortion has been observed in women with Type 1 Gaucher's disease, especially if disease symptoms are not treated and controlled before conception and during pregnancy. Disease manifestations that may lead to adverse pregnancy outcomes, include hepatosplenomegaly which can interfere with the normal growth of a fetus and thrombocytopenia which can lead to increased bleeding and possible postpartum hemorrhage requiring transfusion. There are no controlled data in human pregnancy.

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 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.

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There is no data on the presence of this drug in human milk. It is a biosynthetic enzyme that is closely related to beta-glucocerebrosidase which is a normal component of human milk. Because it is a large protein molecule, if it is present in human milk, its concentration is likely to be very low and infant absorption unlikely as it would probably be destroyed in the infant's gastrointestinal tract. A panel of experts reports that breastfeeding complications were less frequent in mothers treated for Gaucher's disease while breastfeeding than untreated mothers. These mothers were treated with alglucerase or imiglucerase, other biosynthetic forms of the enzyme.

Caution is recommended

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

Comments:
-To avoid excessive bone loss in the nursing mother, consider limiting breastfeeding to about 6 months.

See references