Is Agalsidase Alfa safe while breastfeeding?

Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Agalsidase Alfa. The text below is quoted from that source — it is not our own verdict.

Summary of use during breastfeeding

Agalsidase alfa is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Because it is a large protein molecule with a molecular weight of about 100,000, 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 agalsidase alfa experienced no adverse effects associated with the drug.

Effects on the breastfed infant

Six patients with Fabry 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 milk supply

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

Levels in milk

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.

Alternatives LactMed lists

Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Agalsidase Alfa” (LM1446). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.