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Alirocumab Pregnancy and Breastfeeding Warnings

Alirocumab is also known as: Praluent

Alirocumab Pregnancy Warnings

In animal reproduction studies, there were no effects on embryo-fetal development when rats were subcutaneously administered this drug during organogenesis at dose higher than the maximum recommended human dose. In monkeys, suppression of the humoral immune response was observed in infant monkeys when this drug was dosed during organogenesis to parturition at dose higher than the maximum recommended human dose. 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 placenta. Experience with monoclonal antibodies in humans indicates that IgG antibodies are unlikely to cross the placenta during the first trimester; however, during the second and third trimester, increased amounts of this drug are likely to cross the placenta. 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

Alirocumab Breastfeeding Warnings

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. Praluent Pen (alirocumab)." sanofi-aventis, Bridgewater, NJ.

References for breastfeeding information

  1. "Product Information. Praluent Pen (alirocumab)." sanofi-aventis, Bridgewater, NJ.

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