This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action and findings in animal models, this drug can cause fetal harm when administered during pregnancy; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-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.
-Pregnancy status of patients of childbearing potential should be verified before starting this drug.
-Patients of childbearing potential should be advised to use effective contraception during therapy and for 3 months after the last dose.
-Human immunoglobulin G1 (IgG1) crosses the placenta; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.

Animal studies have not been reported; however, based on its mechanism of actions, this drug can cause fetal harm or developmental anomalies. Administration of epidermal growth factor receptor (EGFR) and mesenchymal-epidermal transition (MET) inhibitors in pregnant animals resulted in an increased incidence of impaired embryofetal development, embryolethality, and abortion. In mice, EGFR is very important in reproductive and developmental processes (including blastocyst implantation, placental development, and embryofetal/postnatal survival and development). Reduction/elimination of embryofetal or maternal EGFR signaling can prevent implantation, cause embryofetal loss during gestation (through effects on placental development), and cause developmental anomalies and early death in surviving fetuses. Adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted EGFR signaling. Similarly, knock out of MET or its ligand HGF (hepatocyte growth factor) was embryonic lethal due to severe defects in placental development, and fetuses displayed defects in muscle development in multiple organs. 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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Since this drug is a large protein molecule (molecular weight about 148 kilodaltons), the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract; absorption by the infant is probably minimal.

Breastfeeding is not recommended during use of this drug and for 3 months after the last dose.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions.

See references