Label Changes for:
Istodax (romidepsin) for Injection
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011
WARNINGS and PRECAUTIONS
Use in Pregnancy
- There are no adequate and well-controlled studies of Istodax in pregnant women. However, based on its mechanism of action and findings in animals, Istodax may cause fetal harm when administered to a pregnant woman. In an animal reproductive study, romidepsin was embryocidal and resulted in adverse effects on the developing fetus at exposures below those in patients at the recommended dose of 14 mg/m2/week. If this drug is used during pregnancy, or if the patient becomes pregnant while taking Istodax, the patient should be apprised of the potential hazard to the fetus.