Last update Oct. 21, 2023

Agalsidase Alfa. Agalsidase Beta

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Agalsidases alpha and beta are similar recombinant forms of the endogenous enzyme alpha galactosidase A. Their amino acid sequence is identical to that of the natural enzyme. They are used to treat by enzyme replacement Fabry disease, a lysosomal deposit disease caused by a genetic deficiency in the enzyme alpha-galactosidase A, which leads to the accumulation of glycosphingolipids such as globotriaosylceramide in the walls of blood vessels and smooth muscle. Administration by intravenous infusion every two weeks. Alpha galactosidase alfa has been used orally to reduce intestinal gas production (Di Stefano 2007).

At the time of the last update, we found no published data on its excretion in breast milk.

Its high molecular weight makes it unlikely to be excreted in breast milk in significant quantities.

Due to its protein nature, it is inactivated in the gastrointestinal tract, not being absorbed (oral bioavailability practically null), which prevents its passage into infant plasma from ingested breast milk, except in premature infants and immediate neonatal period, in which there may be greater intestinal permeability.

No treatment-related adverse effects were observed in six infants of mothers treated with agalsidase alfa. (Fernández 2019)

 

Alternatives

We do not have alternatives for Agalsidase Alfa. Agalsidase Beta since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Agalsidase Alfa. Agalsidase Beta is also known as


Agalsidase Alfa. Agalsidase Beta in other languages or writings:

Tradenames

Main tradenames from several countries containing Agalsidase Alfa. Agalsidase Beta in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 45.352 daltons
Protein Binding 0 %
VD 0.003 (0.001 - 0.1) l/Kg
0.7 - 1.7 hours

References

  1. Fernández P, Fernández SO, Gonzalez JGM, Fernández T, Fernández CC, Fernández SP. Enzyme Replacement Therapy in Pregnant Women with Fabry Disease: A Case Series. JIMD Rep. 2019;45:77-81. Abstract Full text (link to original source)
  2. Takeda. Agalsidase alfa. Drug Summary. 2017 Full text (in our servers)
  3. Di Stefano M, Miceli E, Gotti S, Missanelli A, Mazzocchi S, Corazza GR. The effect of oral alpha-galactosidase on intestinal gas production and gas-related symptoms. Dig Dis Sci. 2007 Abstract
  4. EMA. Agalsidasa alfa. Ficha técnica. 2006 Full text (in our servers)
  5. Ganiats TG, Norcross WA, Halverson AL, Burford PA, Palinkas LA. Does Beano prevent gas? A double-blind crossover study of oral alpha-galactosidase to treat dietary oligosaccharide intolerance. J Fam Pract. 1994 Abstract
  6. Smiley KL, Hensley DE, Gasdorf HJ. Alpha-galactosidase production and use in a hollow-fiber reactor. Appl Environ Microbiol. 1976 Abstract

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