Enfortumab vedotin Pregnancy Warnings
Animal studies have revealed evidence of maternal toxicity, embryotoxicity, and embryolethality at doses equal to the recommended human dose. Structural malformations included gastroschisis, malrotated hindlimb, absent forepaw, malpositioned internal organs and fused cervical arch, skeletal anomalies (e.g., asymmetric, fused, incompletely ossified, and misshapen sternebrae, misshapen cervical arch, and unilateral ossification of the thoracic centra). There are no controlled data in human pregnancy.
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.
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on the mechanism of action and findings in animals, this drug can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, administration of this drug to pregnant rats during organogenesis caused maternal toxicity, embryofetal lethality, structural malformations, and skeletal anomalies at maternal exposures like the exposures at the recommended human dose.
Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-Advise females of reproductive potential to use effective contraception during therapy and for 2 months after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 4 months after.
-This drug may impair male fertility.
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