Summary of Use during Lactation

No information is available on the clinical use of pegunigalsidase alfa during breastfeeding. Because pegunigalsidase alfa is a large protein molecule with a molecular weight of 116,000 Da, the amount in milk is likely to be very low.[1] It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[2] Polyethylene glycol is not excreted into breastmilk.[3] If pegunigalsidase alfa is required by the mother, it is not a reason to discontinue breastfeeding.

Drug Levels

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

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

References

1.

Stratigakis A, Paty D, Zou P, et al. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207. doi:10.1016/j.repbre.2023.10.003 [CrossRef]

2.

Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med 2021;16:591-3. [PubMed: 33956488]

3.

Clowse ME, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: Results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis 2017;76:1890-6. [PMC free article: PMC5705850] [PubMed: 28814432]

Substance Name

Pegunigalsidase Alfa

CAS Registry Number

1644392-61-9

Drug Class

Breast Feeding

Lactation

Milk, Human

Enzymes