Empaveli Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.
Risk Summary: There are insufficient data on use in pregnant females to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Comments:
-Females of reproductive potential should have a pregnancy test prior to starting treatment.
-Advise female patients of reproductive potential to use effective contraception during treatment and for at least 40 days after the last dose. Some authorities recommend using effective contraception for at least 8 weeks after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal reproduction studies conducted in cynomolgus monkeys using subcutaneous doses of 28 mg/kg/day (2.9 times the human exposure based on AUC) showed a statistically significant increase in abortions and stillbirths compared to the control group. No increase in abortions or stillbirths were seen at a dose of 7 mg/kg/day (1.3 times the human exposure based on AUC). No developmental effects were observed in infants up to 6 months postpartum. Systemic exposure to this drug of less than 1% of maternal levels was detected in fetuses from animals treated with 28 mg/kg/day from the period of organogenesis through the second trimester. 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.
AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain 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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