Animal studies have failed to reveal evidence of impaired fertility or embryofetal toxicity at daily doses up to 0.4 to 0.5 times the human steady-state AUC at recommended human biweekly dose during organogenesis; however, increase in mouse pup mortality observed when dose was given every other day during organogenesis through lactation at 0.4 times the human steady-state AUC at recommended human biweekly dose. There are no controlled data in human pregnancy.

The Pompe Registry monitors the effect of this drug on pregnant women and their offspring. For additional information and enrollment: pomperegistry.com

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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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.

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category:
-Lumizyme(R): C
-Myozyme(R): B

See references

The Pompe Registry collects data on breastfeeding women treated with this drug. For additional information and enrollment: pomperegistry.com

In 1 woman, alglucosidase alfa activity was evident in breast milk for only 24 hours after a dose.

At 3 and 77 days of age, anti-alglucosidase alfa antibodies were negligible in the serum of an infant born to a mother receiving alglucosidase alfa 20 mg/kg IV every 2 weeks during pregnancy and lactation. This infant was examined regularly up to 1 year of age and showed normal development; extent of breastfeeding was not reported.

LactMed: As a precaution, breastfeeding should be withheld for 24 hours after each dose.
-AU: Use is recommended only if clearly needed and after careful benefit/risk analysis for mother and child.
-UK: Breastfeeding should be stopped when this drug is used.
-US: Caution is recommended; to minimize infant exposure, the nursing mother may pump and discard breast milk produced during the 24 hours after drug administration.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-This drug is a large protein molecule (molecular weight about 110,000); the amount in milk is likely to be very low; absorption unlikely as it is probably destroyed in the infant gastrointestinal tract.

See references