Alirocumab Pregnancy and Breastfeeding Warnings

Brand names: Praluent

Alirocumab Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: B1
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.

Comments:
-A pregnancy exposure registry has been established to monitor pregnancy outcomes in women exposed to this drug during pregnancy; to enroll or obtain information: https://mothertobaby.org/ongoing-study/praluent/ or call 1-877-311-8972.

In animal reproduction studies, there were no effects on embryo-fetal development when rats were subcutaneously administered this drug during organogenesis at doses 12 times higher than the maximum recommended human dose (MRHD). In monkeys, suppression of the humoral immune response was observed in infant monkeys when this drug was dosed during organogenesis to parturition at doses higher than MRHD. 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. FDA 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.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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.

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Alirocumab Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-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.

Human IgG is present in human milk, but published data suggest that breastmilk IgG antibodies do not enter the neonatal and infant circulation in substantial amounts. Because this drug is a large protein molecule, if present in human milk, the amount is likely to be very low and absorption unlikely because it will probably be destroyed in the infant's gastrointestinal tract. Until more data become available, caution is advised, especially while nursing a newborn or preterm infant. Some authorities advise against breastfeeding.

See references

Further information

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