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Romidepsin Pregnancy and Breastfeeding Warnings

Romidepsin is also known as: Istodax

Medically reviewed by Drugs.com. Last updated on May 14, 2020.

Romidepsin Pregnancy Warnings

Use should be avoided.

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

Risk Summary: Based on its mechanism of action and findings from animal studies, this drug can cause embryofetal harm when administered to a pregnant woman.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-This drug may reduce the effectiveness of estrogen-containing contraceptives. Alternative methods of non-estrogen containing contraception (e.g., condoms, intrauterine devices) should be used in patients receiving this drug.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 1 month after.
-Advise males with female partners of reproductive potential to use effective contraception and to avoid fathering a child during therapy and for at least 1 month after.

Animal studies have revealed evidence of embryotoxicity and teratogenicity at recommended 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. Substantial resorption or postimplantation loss was observed at the high-dose of 0.5 mg/kg/day, a maternally toxic dose. 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.

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

Comments:
-Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during therapy and for at least 1 week after.

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.