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Pegvaliase Pregnancy and Breastfeeding Warnings

Pegvaliase is also known as: Palynziq

Medically reviewed by Drugs.com. Last updated on Jul 15, 2019.

Pegvaliase Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: Based on animal studies, this drug may cause fetal harm; there is limited available data to inform a drug-associated risk of adverse developmental outcomes in humans. There are known fetal risks associated with poorly controlled phenylalanine concentrations in women during pregnancy.

Comments:
-Monitor phenylalanine concentrations during pregnancy in women with phenylketonuria (PKU); blood phenylalanine concentrations should be maintained between 120 and 360 micromol/L during pregnancy and in the 3-months before conception.
-If phenylalanine concentrations fall below 30 micromol/L during pregnancy, adjust dose and/or modify dietary protein and phenylalanine intake.
-Advise pregnant women and those of reproductive potential of the risks to a fetus with this drug.
-Pregnancy Registry: Women who are exposed to this drug during pregnancy or who become pregnant within one month following the last dose are encouraged to report their pregnancy to BioMarin (1-866-906-6100)

The following studies were conducted in animals without PKU. In each study, maternal toxicity was associated with the studied doses; for doses that produced maternal toxicity, the maternal plasma phenylalanine concentrations were markedly reduced compared to the control group. The contribution of these markedly reduced maternal phenylalanine levels to the incidence of embryo-fetal developmental effects was not evaluated. In pregnant rabbits receiving 7.5 times the maximum recommended daily dose, a high incidence of fetal malformations throughout the skeletal system, in the kidneys, lungs, and eyes; and embryo-fetal toxicity including increased resorptions and reduced fetal weight were observed. In pregnant rats receiving 4.2 times the maximum recommended daily dose, increased skeletal variations with no malformations were observed. In a pre- and post-natal study in rats at 19.4 times the maximum recommended daily dose, reduced offspring survival during lactation, decreased pup weight and litter size, and delayed sexual maturation of offspring were observed. In women, uncontrolled phenylalanine concentrations before and during pregnancy are associated with an increased risk of adverse pregnancy outcomes. Available data from the Maternal Phenylketonuria Collaborative Study (n=468 pregnancies; 331 live births in women with PKU) have shown that phenylalanine concentrations above 600 micromol/L are associated with an increased risk for miscarriage, major birth defects (including microcephaly, major cardiac malformations), intrauterine fetal growth retardation, and future intellectual disability with low IQ. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Pegvaliase Breastfeeding Warnings

This drug is present in rat milk. Maternal administration in dams during lactation decreased pup weight and survival although systemic absorption was not detected in rat pups. If this drug was to be present in human milk, it may lower phenylalanine concentrations.

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Monitor blood phenylalanine concentrations in breastfeeding women.
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production; The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Palynziq (pegvaliase)." BioMarin Pharmaceutical Inc, Novato, CA.

References for breastfeeding information

  1. "Product Information. Palynziq (pegvaliase)." BioMarin Pharmaceutical Inc, Novato, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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