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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.
CASRN: 1585984-95-7
Drug Levels and Effects
Summary of Use during Lactation
No information is available on the use of pegvaliase during breastfeeding, but amounts in milk appear to be trivial. Absorption of the drug by the infant from breastmilk is unlikely because it is a polypeptide that is probably destroyed in the infant's gastrointestinal tract. Pegvaliase may decrease the phenylalanine content of breastmilk. The manufacturer recommends monitoring blood phenylalanine concentrations in breastfeeding women treated with pegvaliase.
Drug Levels
Maternal Levels. A woman with phenylketonuria stopped her pegvaliase during pregnancy and for 7 months while breastfeeding her infant. After weaning, she restarted pegvaliase and pumped breastmilk samples for analysis while taking a dose of 20 mg daily. The activity of phenylalanine ammonia lyase (the active portion of pegvaliase) was equal to background levels found in blank breastmilk and TRIS buffer solution.[1]
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.
- Rohr F, Kritzer A, Harding CO, et al. Discontinuation of pegvaliase therapy during maternal PKU pregnancy and postnatal breastfeeding: A case report. Mol Genet Metab Rep. 2020;22:100555. [PMC free article: PMC6957825] [PubMed: 31956506]
Substance Identification
Substance Name
Pegvaliase
CAS Registry Number
1585984-95-7
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- Review Pegvaliase: a novel treatment option for adults with phenylketonuria.[Curr Med Res Opin. 2019]Review Pegvaliase: a novel treatment option for adults with phenylketonuria.Mahan KC, Gandhi MA, Anand S. Curr Med Res Opin. 2019 Apr; 35(4):647-651. Epub 2018 Oct 25.
- Review A Comprehensive Review of Pegvaliase, an Enzyme Substitution Therapy for the Treatment of Phenylketonuria.[Drug Target Insights. 2019]Review A Comprehensive Review of Pegvaliase, an Enzyme Substitution Therapy for the Treatment of Phenylketonuria.Hydery T, Coppenrath VA. Drug Target Insights. 2019; 13:1177392819857089. Epub 2019 Jun 21.
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