In rats dosed at about 6 times the recommended human dose, an increased number of late resorptions, dead fetuses, post implantation losses, reduced fetal body weight, fetal cerebral variations (dilated cerebral ventricles), fetal skeletal variations (poor bone ossification), and fetal malformations (abnormal number of ribs or lumbar vertebra) occurred. Doses at which these effects occurred were associated with maternal toxicity. In rabbits, dosed up to 10 times the recommended human dose, fetal harm was not observed; mild maternal toxicity was observed. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned

Risk Summary: Limited data are not sufficient to assess drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Comments:
-Women with Gaucher disease are at an increased risk of spontaneous abortion, especially if disease symptoms are not controlled prior to conception and during pregnancy.

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Benefit should outweigh risk

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

Comments: The effects in the nursing infant are unknown.

Approximately 0.23% of radioactivity was excreted in milk within 24 hours following a single radiolabeled dose of 30 mg/kg to female rats on postpartum day 11. The concentration of drug in rat milk at 24 hours post dose was 16.3-fold higher than plasma. Daily administration to dams through weaning resulted in decreased body weight in dams and offspring. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

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