Call Text Chat Email Refer a Patient Join a Study

Search

MotherToBaby

Medications and More during pregnancy and breastfeeding

​​Pegvaliase (Palynziq®)​

Selected References:

  • American Academy of Pediatrics Committee on Genetics. 2008. Maternal phenylketonuria. Pediatrics 122:445–449. 
  • American College of Obstetricians and Gynecologists Committee on Genetics. 2020. Management of women with phenylalanine hydroxylase deficiency (phenylketonuria). Obstet Gynec, 135(4):e167-e170.  
  • Bier C, et al. 2024. Outcomes in 14 live births resulting from Pegvaliase-treated pregnancies in PKU-affected females. Mol Genet Metab, 141(3):108152. 
  • BioMarin Pharmaceutical Inc. Palynziq medication label. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6dba844a-db02-44f8-8593-ce497ed9406c&type=display. Accessed 27 October 2025.  
  • Cunningham A, et al. 2023. Nutrition management of PKU with pegvaliase therapy: Update of the web-based PKU nutrition management guideline recommendations. Orphanet J Rare Dis, 18:155. 
  • Fisch RO, et al. 1981 Semen studies on phenylketonurics. Biochem Med, 26(3):427434. Kopesky JJ, et al. 2024. Successful outcomes with continued pegvaliase-pqpz treatment throughout pregnancy and lactation in a PKU patient. Mol Genet Metab, 141:18. 
  • Levy HL, Waisbren SE. 1983. Effects of untreated maternal phenyketonura and hyperphenylalaninemia on the fetus. N Engl J Med, 309:1269-1274.  
  • Rohr F, et al. 2020. Discontinuation of pegvaliase therapy during maternal PKU pregnancy and postnatal breastfeeding: A case report. Mol Genet Metab Rep, 22:100555.  
  • Rohr F, et al. 2022. Reinstitution of pegvaliase therapy during lactation. Mol Genet Metab Rep, 33:100938.  
  • Teissier R, et al. 2012. Maternal phenylketonuria: low phenylalaninemia might increase the risk of intra uterine growth retardation. J Inherit Metab Dis, 35(6):993-999.  
  • U.S. Food and Drug Administration Center for Drug Evaluation and Research. Active Risk Identification and Assessment (ARIA) Sufficiency Memo for Pregnancy Safety Concerns. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761079Orig1s000OtherR.pdf. Accessed 27 October 2025. 
  • Waisbren SE, et al. 2015. Maternal phenylketonuria: long-term outcomes in offspring and post-pregnancy maternal characteristics. JIMD Rep, 21:23-33. 

 

This website is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $1,200,000 with zero percentage financed with non-governmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, HRSA, HHS, or the U.S. Government.