Summary of Use during Lactation

Limited information from on mother receiving laronidase 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 laronidase is required by the mother, it is not a reason to discontinue breastfeeding. Until more data are available, laronidase should be used with careful monitoring during breastfeeding.

Drug Levels

Maternal Levels. A woman with mucopolysaccharidosis type I received intravenous laronidase 100 units/kg weekly during breastfeeding, beginning one week after delivery. Laronidase was undetectable (assay limits not specified) in breastmilk just before the infusion and 60 minutes after the infusion at 1 and 3 months postpartum.[1]

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

Effects in Breastfed Infants

A woman with mucopolysaccharidosis type I received intravenous laronidase 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]

Effects on Lactation and Breastmilk

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

References

1.

Castorina M, Antuzzi D, Richards SM, et al. Successful pregnancy and breastfeeding in a woman with mucopolysaccharidosis type I while receiving laronidase enzyme replacement. therapy. Clin Exp Obstet Gynecol. 2015;42:108–13. [PubMed: 25864295]

Substance Name

Laronidase

CAS Registry Number

210589-09-6

Drug Class

Breast Feeding

Lactation

Enzymes

Enzyme Replacement Therapy

Hexosaminidases