Summary of Use during Lactation

No information is available on the clinical use of cipaglucosidase alfa during breastfeeding. Because cipaglucosidase alfa is a large protein molecule with a molecular weight of about 110,000 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] However, the drug is given with miglustat, which has no safety information during breastfeeding, so the manufacturer recommends that neither drug be given to nursing mothers. An alternate drug may be preferred.

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.

Alternate Drugs to Consider

Alglucerase, Imiglucerase, Taliglucerase Alfa

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]

Substance Name

Cipaglucosidase Alfa

CAS Registry Number

2359727-71-0

Drug Class

Breast Feeding

Lactation

Milk, Human

Enzymes

Enzyme Replacement Therapy