Section 16 · Monograph
Givinostat
Reviewed Nov 2026FDA label
DuvyzatHDAC inhibitor
- Forms
- Oral suspension (weight-based dosing)
- Dose
- Weight-based BID with food (DMD, age 6+)
- MOA
- Inhibits histone deacetylases, ↓muscle inflammation and fibrosis
Indications
- Treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and olderFDA-labeled
Mechanism of Action
- Histone deacetylase (HDAC) inhibitor that reduces muscle inflammation and fibrosis and promotes regeneration; works regardless of DMD mutation type
Full Dosing
Adult / usual
- Weight-based oral suspension twice daily with food
Renal
- Confirm the exact weight-band dose, dose modifications and hepatic/renal adjustments against the current prescribing information
Contraindications
- None listed in labeling
Drug Interactions
- Avoid combination with other QT-prolonging drugs
- Check co-medications for CYP interactions per current label
Adverse Effects
- Diarrhea, abdominal pain, nausea and vomiting
- Thrombocytopenia
- Hypertriglyceridemia
- QT prolongation
- Increased creatinine
Monitoring Parameters
- Platelet counts
- Triglycerides
- ECG/QTc
- GI symptoms
Pregnancy & Lactation
- Limited data; weigh risks and benefits