Zynlonta Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on its mechanism of action, this drug can cause embryofetal harm when administered during pregnancy, because it contains a genotoxic compound (SG3199) that targets rapidly dividing cells.
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 women of reproductive potential to use effective contraception during therapy and for 9 months after.
-Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during therapy and for 6 months after.
-Based on results from animal studies, this drug may permanently impair fertility in males.
Animal studies were not conducted with this drug. The cytotoxic component, crosslinks DNA, is genotoxic and is toxic to rapidly dividing cells, so it may cause embryotoxicity and teratogenicity. 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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