Revised SPC: Dacogen (decitabine) 50 mg powder for concentrate for solution for infusion

Source:
electronic Medicines Compendium - eMC
Publisher:
electronic Medicines compendium
Publication date:
13 February 2019

Abstract

SPC now warns cases of cardiomyopathy with cardiac decompensation, in some cases reversible after treatment discontinuation, dose reduction or corrective treatment, have been reported in postmarketing setting. Patients, should be monitored for signs and symptoms of heart failure.