Recommended Evaluation and Testing Before Initiation  

- Obtain baseline platelet counts and fasting triglycerides. Do not initiate if platelets <150 × 10⁹/L.  

- Perform ECG in patients with cardiac disease or those taking QT-prolonging drugs.  

Recommended Dosage  

Weight-based dosing (twice daily with food):  

- 10 kg to <20 kg: 22.2 mg (2.5 mL) twice daily.  

- 20 kg to <40 kg: 31 mg (3.5 mL) twice daily.  

- 40 kg to <60 kg: 44.3 mg (5 mL) twice daily.  

- ≥60 kg: 53.2 mg (6 mL) twice daily.  

Dosage Modifications for Adverse Reactions  

For thrombocytopenia, diarrhea, or hypertriglyceridemia:  

- First modification: Reduce dose by ~20% (e.g., 60 kg patient: 53.2 mg → 39.9 mg).  

- Second modification: Further reduce dose by ~15% (e.g., 60 kg patient: 39.9 mg → 35.4 mg).  

- Discontinue if reactions persist after two modifications.  

For QTc prolongation (>500 ms or Δ >60 ms): Withhold DUVYZAT.  

Preparation and Administration  

- Shake the bottle vertically for ≥30 seconds.  

- Use the provided graduated syringe to measure the dose. Administer orally with food.  

- Discard unused suspension 60 days after opening.  

Missed Dose  

Skip the missed dose; do not double the next dose. 

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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