Is Aldurazyme Safe in Breastfeeding
Question
I am a breastfeeding mother and i want to know if it is safe to use Aldurazyme? Is Aldurazyme safe for nursing mother and child? Does Aldurazyme extracts into breast milk? Does Aldurazyme has any long term or short term side effects on infants? Can Aldurazyme influence milk supply or can Aldurazyme decrease milk supply in lactating mothers?
Aldurazyme lactation summary
- DrLact safety Score for Aldurazyme is 3 out of 8 which is considered Low Risk as per our analyses.
- A safety Score of 3 indicates that usage of Aldurazyme may cause some minor side effects in breastfed baby.
- Our study of different scientific research indicates that Aldurazyme may cause moderate to no side effects in lactating mother.
- Most of scientific studies and research papers declaring usage of Aldurazyme low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
- While using Aldurazyme We suggest monitoring child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
- Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.
Answer by Dr. Ru: About Aldurazyme usage in lactation
Recombinant-type of alfa-L-iduronidase that is used in enzyme replacement therapy in patients with Mucopolysaccharidosis I (MPS I). Its high molecular weight explains the null passage observed in the milk of a nursing mother who had received weekly doses of Aldurazyme for three months, while she was breastfeeding. No physical or developmental problems in infants in the short or long term were observed. Its low oral bioavailability hampers its passage from the breast milk ingested to the infant's plasma since it is degraded in the gastrointestinal tract due to its proteinaceous nature. It is not absorbed by the gut except in the immediate neonatal period or prematurity when intestinal permeability may be increased. Weekly administration and short half life span allows, if desired, developing strategies to further minimize the risk of exposure (e.g. avoid breastfeeding between 4 and 8 hours after receiving a dose, using the "pump and dump method" of the breast milk while the baby is fed with previously extracted milk)
Answer by DrLact: About Aldurazyme usage in lactation
Limited information from on mother receiving Aldurazyme for mucopolysaccharidosis type I indicates that the drug is not detectable in breastmilk and her breastfed infant suffered no adverse reactions or adverse developmental effects from the drug in milk. If Aldurazyme is required by the mother, it is not a reason to discontinue breastfeeding. Until more data are available, Aldurazyme should be used with careful monitoring during breastfeeding.
Aldurazyme Side Effects in Breastfeeding
A woman with mucopolysaccharidosis type I received intravenous Aldurazyme 100 units/kg weekly for 28 doses during her 37-week pregnancy. She resumed therapy one week after delivery and breastfed her infant for 3 months. The infant had normal height and weight up to 12 months of age and showed normal development at 2.5 years of age. No adverse drug reactions were reported in the infant.[1]