Recommended Evaluation and Testing Before Initiation
Obtain and evaluate baseline platelet counts and triglycerides prior to initiation.
Do not initiate DUVYZAT in patients with a platelet count less than 150 x 10⁹/L.
In patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs when initiating treatment, during concomitant use, and as clinically indicated.
Recommended Dosage
The recommended dosage of DUVYZAT is based on body weight and administered orally twice daily with food:
10 kg to less than 20 kg: 22.2 mg (2.5 mL) twice daily
20 kg to less than 40 kg: 31 mg (3.5 mL) twice daily
40 kg to less than 60 kg: 44.3 mg (5 mL) twice daily
60 kg or more: 53.2 mg (6 mL) twice daily
Dosage Modifications for Adverse Reactions
Dosage modifications may be necessary for:
Platelet count <150 x 10⁹/L verified in two assessments one week apart, or
Moderate or severe diarrhea, or
Fasting triglycerides >300 mg/dL verified by two assessments one week apart
First dosage modification:
10 kg to less than 20 kg: 17.7 mg (2 mL) twice daily
20 kg to less than 40 kg: 22.2 mg (2.5 mL) twice daily
40 kg to less than 60 kg: 31 mg (3.5 mL) twice daily
60 kg or more: 39.9 mg (4.5 mL) twice daily
Second dosage modification (if adverse reactions persist):
10 kg to less than 20 kg: 13.3 mg (1.5 mL) twice daily
20 kg to less than 40 kg: 17.7 mg (2 mL) twice daily
40 kg to less than 60 kg: 26.6 mg (3 mL) twice daily
60 kg or more: 35.4 mg (4 mL) twice daily
If adverse reactions persist after the second dosage modification, DUVYZAT should be discontinued.
For QTc interval prolongation: Withhold DUVYZAT if the QTc interval is > 500 ms or the change from baseline is > 60 ms.
Preparation and Administration Instructions
Before use, shake the DUVYZAT suspension for at least 30 seconds by inverting the bottle by 180°.
Visually verify the homogeneity of the suspension.
Using a graduated oral syringe, measure the appropriate volume of suspension corresponding to the prescribed dose.
Administer orally with the provided graduated oral syringe.
Missed Dose
If a dose is missed, patients should not take double or extra doses.
