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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 2359727-71-0
Drug Levels and Effects
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
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 Identification
Substance Name
Cipaglucosidase Alfa
CAS Registry Number
2359727-71-0
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
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- Review Avalglucosidase Alfa.[Drugs and Lactation Database (...]Review Avalglucosidase Alfa.. Drugs and Lactation Database (LactMed®). 2006
- Improved Enzyme Replacement Therapy with Cipaglucosidase Alfa/Miglustat in Infantile Pompe Disease.[Pharmaceuticals (Basel). 2023]Improved Enzyme Replacement Therapy with Cipaglucosidase Alfa/Miglustat in Infantile Pompe Disease.Fiege L, Duran I, Marquardt T. Pharmaceuticals (Basel). 2023 Aug 23; 16(9). Epub 2023 Aug 23.
- Safety and efficacy of cipaglucosidase alfa plus miglustat versus alglucosidase alfa plus placebo in late-onset Pompe disease (PROPEL): an international, randomised, double-blind, parallel-group, phase 3 trial.[Lancet Neurol. 2021]Safety and efficacy of cipaglucosidase alfa plus miglustat versus alglucosidase alfa plus placebo in late-onset Pompe disease (PROPEL): an international, randomised, double-blind, parallel-group, phase 3 trial.Schoser B, Roberts M, Byrne BJ, Sitaraman S, Jiang H, Laforêt P, Toscano A, Castelli J, Díaz-Manera J, Goldman M, et al. Lancet Neurol. 2021 Dec; 20(12):1027-1037.
- Review Cipaglucosidase Alfa: First Approval.[Drugs. 2023]Review Cipaglucosidase Alfa: First Approval.Blair HA. Drugs. 2023 Jun; 83(8):739-745.
- Review Olipudase Alfa.[Drugs and Lactation Database (...]Review Olipudase Alfa.. Drugs and Lactation Database (LactMed®). 2006
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