Zenocutuzumab Pregnancy and Breastfeeding Warnings

Brand names: Bizengri

Zenocutuzumab Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action, this drug can cause fetal harm when administered during pregnancy.

Comments:
-No data are available on the use of this product in pregnant women to inform a drug-related risk.
-Human IgG1 crosses the placenta, so there is the potential to be transmitted from the mother to the developing fetus. Patients should be advised of the potential risk.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Advise female patients of reproductive potential to use effective contraception during treatment with this drug and for 2 months after the last dose.
-There is a risk of clinical complications such as oligohydramnios, if this drug is used in pregnant women, or if a patient becomes pregnant within 2 months after the last dose. If a woman becomes pregnant, she should be monitored closely. If oligohydramnios occurs, fetal testing appropriate for gestational age and consistent with standards of care should be performed.

Animal studies have not been reported. A literature-based assessment of the effects on reproduction demonstrated that human epidermal growth factor receptor 2 and 3 (HER2/HER3) are critically important in embryo-fetal development. HER2 knockout mice or mice expressing catalytically inactive HER2 die at mid-gestation due to cardiac dysfunction. An abnormal sympathetic nervous system development has also been reported. In HER3-deficient mice, embryolethality occurred around day 13 due to cardiac and vascular defects, as well as abnormalities in other organs (neural crest, pancreas, stomach, and adrenal glands). In addition, HER3 has been shown to be involved in mammary gland ductal morphogenesis in mice.

There are no controlled data in human pregnancy. However, literature reports in pregnant women receiving a HER2-directed antibody, reported cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. These occurred in pregnant women who received HER2-directed antibody alone or in combination with chemotherapy. In some case reports, amniotic fluid index increased after use of a HER2-directed antibody was discontinued.

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

Zenocutuzumab Breastfeeding Warnings

Use is not recommended during treatment and for 2 months after the last dose.

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, the effects on a breastfed infant, or effects on milk production.
-Maternal immunoglobulin G1 (IgG1) is known to be present in human milk; however, the effects of local gastrointestinal exposure and limited systematic exposure in the breastfed child are unknown.
-The elimination half-life and wash out period of this drug is of 2 months.

See references

Further information

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