Zynyz Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: Not assigned
Risk summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Human IgG4 immunoglobulins are known to cross the placenta; this drug may be transmitted from the mother to the fetus potentially resulting in immune-mediated rejection and fetal death. Fetal exposure to IgG4 antibodies may also increase the risk of immune-mediated disorders or altered immune response.
Comments:
-There are no data available on the use of this drug in pregnant women to inform a drug-related risk.
-Verify pregnancy status of females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during treatment and for 4 months after last dose of this drug.
No animal studies were conducted to evaluate reproduction and fetal development. In murine models of pregnancy with exposure to programmed death receptor-1 (PD-1) blockade, pregnant animals exhibited disrupted tolerance to the developing fetus with increased fetal loss; thus, potential risks in human pregnancy include increased rates of abortions or stillbirths. Teratogenicity was not observed in animal studies; however, immune-mediated disorders were observed in PD-1/PD-ligand 1 knockout mice. 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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Zynyz Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug due to the potential for serious adverse reactions in breastfed children.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There is no information regarding this drug on the presence in human milk or its effects on milk production.
-This drug is a humanized IgG4 monoclonal antibody, and maternal IgG antibodies are known to be present in human milk; the effects of gastrointestinal exposure and limited systemic absorption in lactating infants are unknown.
-Lactating persons are advised not to breastfeed during treatment and for 4 months after last dose of this drug.
See references
