I am a breastfeeding mother and i want to know if it is safe to use Agalsidase Alfa? Is Agalsidase Alfa safe for nursing mother and child? Does Agalsidase Alfa extracts into breast milk? Does Agalsidase Alfa has any long term or short term side effects on infants? Can Agalsidase Alfa influence milk supply or can Agalsidase Alfa decrease milk supply in lactating mothers?
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.
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. Threee 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]
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