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Evolocumab Pregnancy and Breastfeeding Warnings

Evolocumab is also known as: Repatha, Repatha Pushtronex

Evolocumab Pregnancy Warnings

In animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered this drug from organogenesis through parturition at dose exposures higher than the maximum recommended human dose. Humoral immune suppression occurred in infant monkeys exposed to others PCSK9 inhibitors antibody in the uterus at all doses. No assessment for immune suppression was conducted with this drug in infant monkeys. Measurable serum concentrations of this drug were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that this drug, like other IgG antibodies, crosses the placental barrier. Experience with monoclonal antibodies in humans indicates that they are unlikely to cross the placenta in the first trimester; however, they are likely to cross the placenta in increasing amounts in the second and third trimester. There are no available data on use of this drug in pregnant women. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: Not Assigned Risk Summary: There are no available data on use of this drug in pregnant women to inform a drug associated risk.

See references

Evolocumab Breastfeeding Warnings

Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Repatha (evolocumab)." Amgen USA, Thousand Oaks, CA.

References for breastfeeding information

  1. "Product Information. Repatha (evolocumab)." Amgen USA, Thousand Oaks, CA.

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