Direct Healthcare Professional Communication (DHPC) on Defitelio® (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)
2022.06.13
Active substance: defibrotide
Gentium S.r.l, in agreement with the European Medicines Agency and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that the Study 15-007 comparing defibrotide plus best supportive care (BSC) with BSC as prophylaxis of VOD after HSCT was stopped due to futility. Defitelio® is not to be used as prophylaxis for VOD.
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