Subcutaneous administration in cynomolgus monkeys during the period of organogenesis to parturition at exposures of 30-fold and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, revealed no effects on embryofetal or postnatal development (up to 6 months). Humoral immune suppression occurred in infant monkeys exposed to another PCSK9 inhibitor antibody in the uterus at all doses, but humoral immune suppression has not been tested with this drug. Measurable serum concentrations 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. There are no controlled data in human pregnancy

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.

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; experience with monoclonal antibodies in humans reveals 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.

Comments: A pregnancy exposure registry has been created to monitor pregnancy outcomes; contact 1-800-772-6436 or https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting.

See references

There is no data on clinical use of this drug during breastfeeding. Excretion into milk is likely to be low due to its size, and if it were present, absorption by the infant is likely to be very low because the infant's gastrointestinal tract will probably destroy it. 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.

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.

See references