Alglucosidase Alfa

Drug Levels and Effects:




Summary of Use during Lactation:


Alglucosidasealfaactivity was detectable in breastmilk for only 24 hours after a dose in one woman. The investigators recommended withholding breastfeeding for 24 hours after each dose as a precaution until more data are obtained.[1]


Drug Levels:


Maternal Levels.

One 40-year-old woman with adult-onset Pompe disease receivedalglucosidasealfaduring pregnancy and lactation in an intravenous dose of 20 mg/kg every 2 weeks. Thealglucosidaseactivity in breastmilk before the injection was 3 nmol/hour.ml, Which was about 10% of what the authors had measured in the milk of an unaffected woman. Breastmilk activity peaked 2.5 hours after the end of the infusion at 245 nmol/h.mL which was 0.3% of the peak plasma value. Direct measurement ofalglucosidasealfain the breastmilk of the normal mother and the mother receiving the drug were consistent with these activity measurements.Alglucosidasealfawas undetectable (assay limit not stated) 24 hours after the end of the infusion.[1]

Infant Levels.

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


Effects in Breastfed Infants:


An infant was born to a mother receivingalglucosidasealfaduring pregnancy and lactation in an intravenous dose of 20 mg/kg every 2 weeks for adult-onset Pompe disease. At 3 and 77 days of age, the infant's serum had negligible anti-alglucosidasealfaantibodies. The infant was examined regularly up to 1 year of age and showed normal development, although the extent of breastfeeding during this time was not stated.[1]


Possible Effects on Lactation:


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


References:


1. De Vries JM , Brugma JC, Ozkan L et al. First experience with enzyme replacement therapy during pregnancy and lactation in Pompe disease. Mol Genet Metab. 2011;104:552-5. PMID:21967859



Substance Identification:




Substance Name:

AlglucosidaseAlfa

CAS Registry Number:

420784-05-0

Drug Class:


  • Enzymes

  • Enzyme Replacement Therapy


  • Administrative Information:




    LactMed Record Number:


    907


    Last Revision Date:


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