Summary of Use during Lactation

Minimal information is available on the clinical use of avalglucosidase during breastfeeding. Because avalglucosidase is a large protein molecule with a molecular weight of about 124,000 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] One infant breastfed during maternal avalglucosidase therapy beginning at 2 months postpartum with no apparent adverse effects.

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

A woman with late-onset Pompe disease was treated with alglucosidase starting after delivery. The infant was breastfed, with the instruction not to breastfeed for 24 hours after each infusion. At 2 months postpartum, therapy was changed to avalglucosidase. At 8 months postpartum, the infant was developing normally.[3]

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]

3.

Yanagihara C, Hayasaka Y, Kageyama Y. Pregnancy during enzyme replacement therapy with alglucosidase alfa over a 14-year period in late-onset Pompe disease. Neurol Clin Neurosci 2023;11:97-9. doi:10.1111/ncn3.12695 [CrossRef]

Substance Name

Avalglucosidase Alfa

CAS Registry Number

1802558-87-7

Drug Class

Breast Feeding

Lactation

Milk, Human

Enzymes

Enzyme Replacement Therapy