Zanidatamab Pregnancy and Breastfeeding Warnings

Brand names: Ziihera

Medically reviewed by Drugs.com. Last updated on Jan 13, 2025.

Zanidatamab Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned

Risk summary: Based on mechanism of action, this drug can cause fetal harm when used during pregnancy; no data are available on the use of this drug in pregnant women.

Comments:
-The patient should be apprised of the potential harm to the fetus.
-Before starting this drug, pregnancy status should be verified in patients of childbearing potential.
-Patients of childbearing potential should be advised to use effective contraception during therapy and for 4 months after the last dose.
-Women who received this drug during pregnancy or within 4 months before conception should be monitored for oligohydramnios; if oligohydramnios occurs, fetal testing appropriate for gestational age and consistent with local standard of care should be performed.

Animal studies have not been reported. There are no controlled data in human pregnancy.

Cases of oligohydramnios and oligohydramnios sequence (manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death) have been reported with use of a HER2-directed antibody during 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.

See references

Zanidatamab Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-The drug half-life (about 21 days) and washout period (4 months) should be considered.
-Human immunoglobulin G (IgG) may be present in human milk but does not enter neonatal or infant circulation in significant amounts.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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