DUVYZAT requires vigilance for hematologic, metabolic, cardiac, and gastrointestinal risks.  

Risk Mitigation and Monitoring Strategies  

1. Hematologic: Thrombocytopenia (33% incidence), anemia, and neutropenia necessitate biweekly platelet monitoring for 2 months, then monthly. Severe cases may require dose reduction or discontinuation.  

2. Metabolic: Hypertriglyceridemia (23% incidence) mandates fasting lipid checks at 1, 3, and 6 months. Persistent elevation despite dietary intervention warrants discontinuation.  

3. Cardiac: Avoid in congenital long QT syndrome or with QT-prolonging drugs. Baseline and periodic ECGs are required for high-risk patients.  

4. Gastrointestinal: Diarrhea (37%) and vomiting (32%) may require antiemetics/antidiarrheals, hydration, and dose modification.  

5. Drug Interactions: Weak CYP3A4 and OCT2 inhibition necessitates caution with sensitive substrates (e.g., midazolam). Hepatic impairment increases exposure; renal impairment has no specified impact.  

Duvyzat(Givinostat)
Male patients aged 6 years and older with genetically confirmed DMD, ambulatory or non-ambulatory, on stable corticosteroid therapy.
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