Avalglucosidase Alfa and Breastfeeding

Summary of use during lactation

Information available on the clinical use of avalglucosidase during breastfeeding indicates that it does not increase the alphaglucosidase activity of infants breastfed by mothers taking the drug. Two infants breastfed during maternal avalglucosidase therapy had no apparent adverse effects and were developing normally. No special precaution appear to be necessary.

Drug levels in milk and infant serum

Maternal Levels. Relevant published information was not found as of the revision date. Infant Levels. Acid alphaglucosidase activity was measured in 6 dried blood spots from an infant whose mother was receiving avalglucosidase alfa 20 mg/kg every 2 weeks. Samples taken at various times after the maternal infusion had values ranging from about 1 to 9 micromol/L/hour of acid alphaglucosidase activity. In comparison, the mother’s blood acid alphaglucosidase activities before a dose were 0.5 micromol/L/hour and 169 micromol/L/hour 4 hours after a dose.[1]

Effects in breastfed infants

A woman with late-onset Pompe disease was treated with alglucosidase starting after delivery. The infant was breastfed, with the instruction not to breastfeed for 24 hours after each infusion. At 2 months postpartum, therapy was changed to avalglucosidase. At 8 months postpartum, the infant was developing normally.[2] A woman with late-onset Pompe disease was treated with avalglucosidase 20 mg/kg every 2 weeks during pregnancy and postpartum. Her infant was exclusively breastfed for 6 months and partially thereafter. The child was developing normally at follow-up at the age of 9 months.[1]

Effects on lactation and breastmilk

Relevant published information was not found as of the revision date.

Alternative drugs to consider

Alglucerase, Imiglucerase, Taliglucerase Alfa

References

1. Bachmann M, Kasper D, Scholl-Bürgi S, et al. Enzyme replacement therapy during pregnancy and breastfeeding in late-onset Pompe disease. Int Breastfeed J 2025;20:9241462273 PubMed
2. Yanagihara C, Hayasaka Y, Kageyama Y. Pregnancy during enzyme replacement therapy with alglucosidase alfa over a 14-year period in late-onset Pompe disease. Neurol Clin Neurosci 2023;11:97-9. doi:10.1111/ncn3.12695