clear-cut Alglucosidase Alfa use while Breastfeeding Drugs containing Alglucosidase Alfa: Lumizyme, Myozyme Overview Side Effects Dosage Professional Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Alglucosidase Alfa Levels and Effects while Breastfeeding Summary of Use during Lactation Because alglucosidase is a large protein molecule with a molecular weight of about 110,000, 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 Alglucosidase alfa activity 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 received alglucosidase alfa during pregnancy and lactation in an intravenous dose of 20 mg/kg every 2 weeks. The alglucosidase activity 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 of alglucosidase alfa in the breastmilk of the normal mother and the mother receiving the drug were consistent with these activity measurements. Alglucosidase alfa was 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 receiving alglucosidase alfa during 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-alglucosidase alfa antibodies. 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] Effects on Lactation and Breastmilk 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 Alglucosidase Alfa Identification Substance Name Alglucosidase Alfa CAS Registry Number 420784-05-0 Drug Class Enzymes Enzyme Replacement Therapy Administrative Information LactMed Record Number 907 Last Revision Date 20130907 Disclaimer Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site. Print this page Disclaimer: This information is not intended as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. Use of this website signifies your agreement to the Terms of Use and Online Privacy Policy. More about alglucosidase alfa Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group En Español 0 Reviews Add your own review/rating Drug class: lysosomal enzymes Consumer resources Alglucosidase alfa injection Alglucosidase Alfa Alglucosidase alfa Intravenous (Advanced Reading) Other brands: Lumizyme , Myozyme Professional resources Alglucosidase Alfa (AHFS Monograph) Alglucosidase Alfa (Wolters Kluwer) Related treatment guides Pompe disease Drug Status Rx Availability Prescription only Pregnancy Category Risk depends on usage N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Alglucosidase alfa Rating No Reviews - Be the first! 1.0 /10 No Reviews - Be the first! 1.0 Rate it! Drug Class Lysosomal enzymes learners
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