Enspryng Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
US FDA pregnancy category: Not assigned.
Risk Summary: There are no data on the developmental risk associated with the use of this drug in pregnant women. In animal studies, no adverse effects on maternal animals or fetal development were observed in monkeys with administration of doses up to 50 mg/kg/week.
Comments:
-Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester.
Animal studies have failed to reveal evidence of fetal harm. Weekly subcutaneous administration of this drug (or 50 mg/kg) to monkeys throughout pregnancy resulted in no adverse effects on postnatal development of the offspring; however, immune function was impaired in offspring at both doses. Plasma exposures in dams at the low and high doses were approximately 3 and 100 times, respectively, that in humans at the recommended monthly maintenance dose of 120 mg. There are no controlled data in human pregnancy; it is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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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