Is Taliglucerase 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 Taliglucerase alfa. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Taliglucerase alfa is a biosynthetic synthetic enzyme closely related to beta-glucocerebrosidase, which is a normal component of human milk. Because it is a large protein molecule with a molecular weight of about 61,000 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.[1,2] Preliminary evidence indicates that breastfeeding while taking Taliglucerase does not harm the breastfed infant. International panels of clinicians that treat Gaucher's disease recommend breastfeeding with enzyme replacement therapy such as imiglucerase.[2,3] Consider limiting the duration of breastfeeding to about 6 months to avoid excessive bone loss in the nursing mother.[2-4]
Effects on the breastfed infant
In the manufacturer-sponsored taliglucerase-alfa international, prospective drug registry, data on adverse events were collected from 24 sites in Albania, Israel, Turkey, and the United States from September 2013 to November 2023. Five women enrolled in the pregnancy-lactation sub-study and had 6 uneventful live birth deliveries. All these participants continued the drug during their pregnancies and while breastfeeding. No unexpected safety issues were identified.[6]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. A woman with Gaucher disease received taliglucerase alfa 20 units/kg intravenously every 2 weeks during pregnancy and postpartum during breastfeeding. One month after delivery, breastmilk samples were collected before, immediately after, and 30 minutes after an infusion of the drug. Beta-glucocerebrosidase activity in breastmilk were: 3.9 nmol/hour/mL before the infusion, 7.1 nmol/hour/mL immediately after infusion, and 7.2 nmol/hour/mL 30 minutes after infusion. These values are lower than those found in the milk of mothers treated with other replacement enzymes. The woman breastfed her infant exclusively on demand through 10 months of age.[5]
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 “Taliglucerase alfa” (LM997). 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.