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Omacetaxine Pregnancy and Breastfeeding Warnings

Omacetaxine is also known as: Synribo

Omacetaxine Pregnancy Warnings

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

Omacetaxine Breastfeeding Warnings

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

References for pregnancy information

  1. "Product Information. Synribo (omacetaxine)." Teva Pharmaceuticals USA, North Wales, PA.

References for breastfeeding information

  1. "Product Information. Synribo (omacetaxine)." Teva Pharmaceuticals USA, North Wales, PA.

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