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.