Zepzelca Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on animal data and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.
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 female patients of reproductive potential to use effective contraception during therapy and for 6 months.
-Males Advise males with a female sexual partner of reproductive potential to use effective contraception during therapy and for 4 months after.
Animal studies have revealed evidence or 100% postimplantation loss in pregnant rats when given during organogenesis at approximately 0.2 times the 3.2 mg/m2 clinical dose to pregnant rats. 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.
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