Agalsidase Beta and Breastfeeding

Summary of use during lactation

No information is available on the clinical use of agalsidase beta during breastfeeding. Because it is a large protein molecule with a molecular weight of about 100,000 Da, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Six infants who were breastfed for periods up to 12 months by mothers taking the closely related drug agalsidase alfa experienced no adverse effects associated with the drug.

Drug levels in milk and infant serum

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

Effects in breastfed infants

Published information on agalsidase beta was not found as of the revision date. However, some information is available on the closely related drug agalsidase alfa. Six patients with Fabray disease were treated with agalsidase alfa 0.2 mg/kg every 2 weeks during pregnancy and postpartum. One infant partially breastfed for 10 months had asthma at age 4 years and an infant who was partially breastfed for 5 months had recurrent urinary tract infections up to 2 years, but was normal at the age of 5 years. Three infants who were exclusively breastfed for 6 months and partially breastfed until 12 months and one partially breastfed for 12 months were normal. None of the adverse effects appear to have been associated with agalsidase alfa.[1]

Effects on lactation and breastmilk

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

Alternative drugs to consider

Agalsidase Alfa

References

1. Fernández P, Fernández SO, González JGM, et al. Enzyme replacement therapy in pregnant women with Fabry disease A case series. JIMD Rep 2019;45:77-81.30406505 PubMed