Duvyzat(Givinostat) Side Effects

Summary: Common adverse reactions include gastrointestinal disturbances, thrombocytopenia, and metabolic changes.  

Clinical and Trial-Observed Safety Profile  

Frequent adverse reactions (≥10% incidence) include diarrhea (37%), abdominal pain (34%), thrombocytopenia (33%), nausea/vomiting (32%), hypertriglyceridemia (23%), and pyrexia (13%). Less common events: rash (9%), arthralgia (8%), and hypothyroidism (5%). Severe cases of bleeding (e.g., epistaxis) and QTc prolongation were observed. 

Postmarketing data on long-term effects (e.g., carcinogenicity) are unavailable. Bone density reduction and neurobehavioral changes were noted in juvenile animal studies. Discontinuation rates in trials were low (2%), but dosage adjustments were frequent for thrombocytopenia (28%) and hypertriglyceridemia (8%). Persistent symptoms despite dose reduction necessitate permanent discontinuation.