This drug is a human vascular endothelial growth factor (VEGF) inhibitor. In animal studies, VEGF inhibition has been shown to cause malformations, embryo-fetal resorption, and decreased fetal weight. VEGF inhibition has also been shown to affect follicular development, corpus luteum function, and fertility. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

Use is recommended only if clearly needed and the benefit outweighs the risk

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Comments:
-Based on this drug's mechanism of action, a potential risk to human embryo-fetal development cannot be ruled out; animal studies have shown VEGF inhibition causes malformations, embryo-fetal resorption, and decreased fetal weight.
-Women of childbearing potential should use highly effective contraception during treatment and for at least 1 month after the last dose.

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Not Recommended

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

Comments:
-Due to lack of information on the effects of this drug on the breastfed infant or the effects on mild product/excretion, the manufacturer recommends infants not breastfeed during maternal treatment and for at least 1 month after the mother's last dose.

See references