Evkeeza Pregnancy Warnings
Use should be avoided
US FDA pregnancy category: Not assigned
Risk Summary: Available human data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; based on animal studies, this drug may cause fetal harm.
Comments:
-Consider obtaining a pregnancy test prior to initiating therapy.
-Patients of childbearing potential should be informed of the risk to a fetus if they become pregnant; effective contraception should be used during treatment and for at least 5 months following the last dose.
-A pregnancy exposure registry is available.
In animal studies, subcutaneous administration of this drug to pregnant rabbits during organogenesis resulted in fetal malformations (doomed head, hydrocephalus, and flexed limbs) at doses below the maximum recommended human dose. Embryofetal effects were not observed with similar administration to pregnant rats. This drug was shown to cross the placental barrier in both rabbits and rats. This drug is a human IgG4 monoclonal antibody, and like human IgG, is presumed to cross the placental barrier and be transmitted from mother to developing fetus. There are no controlled data in human pregnancy.
Pregnancy Registry: If a patient becomes pregnant while receiving this drug, healthcare providers should report exposure by calling 1-833-385-3392.
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.
See references
Evkeeza Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-There are no data on the presence of this drug in breastmilk, the effects on the breastfed infant, or the 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 on the breastfed infant from the drug or the underlying maternal condition.
See references
