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Romidepsin Pregnancy and Breastfeeding Warnings

Romidepsin is also known as: Istodax

Romidepsin Pregnancy Warnings

Romidepsin has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryolethality and fetotoxicity. There are no controlled data in human pregnancy. Romidepsin should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Based on non-clinical findings, male and female fertility may be compromised by treatment with romidepsin. In a 26-week animal toxicology study, romidepsin administration resulted in testicular degeneration. Seminal vesicle and prostate organ weights were decreased in a separate animal study. Romidepsin also showed high affinity for binding to estrogen receptors in pharmacology studies. In a 26-week animal toxicology study, atrophy was seen in the ovary, uterus, vagina and mammary gland of females. Maturation arrest of ovarian follicles and decreased weight of ovaries were observed in a separate animal study.

Romidepsin Breastfeeding Warnings

There are no data on the excretion of romidepsin into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from romidepsin, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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