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Romidepsin Pregnancy and Breastfeeding Warnings

Romidepsin is also known as: Istodax

Medically reviewed on Aug 6, 2018

Romidepsin Pregnancy Warnings

Use should be avoided. If drug is used during pregnancy or if pregnancy occurs, apprise the patient of potential hazard to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments: Romidepsin may reduce the effectiveness of estrogen-containing contraceptives.

Animal studies have revealed that romidepsin is embryocidal and teratogenic to the developing fetus at recommend doses. Systemic exposures in pregnant rats were 1% to 8% of human exposure at the recommended dose of 14 mg/m2/week. Drug-related fetal effects included folded retina, rotated limbs, and incomplete sternal ossification. 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 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.

See references

Romidepsin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

See references

References for pregnancy information

  1. "Product Information. Istodax (romidepsin)." Gloucester Pharmaceuticals, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Istodax (romidepsin)." Gloucester Pharmaceuticals, Cambridge, MA.

Further information

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

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