Animal studies have revealed evidence of embryofetotoxicity. There are no controlled data in human pregnancy.

FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use of omacetaxine is not recommended during pregnancy.

FDA pregnancy category: D

Comment: If omacetaxine is used during pregnancy, or if the patient becomes pregnant while receiving omacetaxine, the patient should be apprised of the potential hazard to the fetus.

See references

A decision should be made to discontinue breast-feeding or discontinue omacetaxine, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

The effects in the nursing infant are unknown.

See references