Source: FDA, National Drug Code (US) Revision Year: 2024
DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
Obtain and evaluate baseline platelet counts and triglycerides prior to initiation of DUVYZAT [see Warnings and Precautions (5.1, 5.2)]. Do not initiate DUVYZAT in patients with a platelet count less than 150 × 109/L. Monitor platelet counts and triglycerides as recommended during treatment to determine if dosage modifications are needed [see Dosage and Administration (2.3)].
In addition, in patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs when initiating treatment with DUVYZAT, during concomitant use, and as clinically indicated [see Dosage and Administration (2.3), Warnings and Precautions (5.4), and Drug Interactions (7.2)].
The recommended dosage of DUVYZAT is based on body weight and administered orally twice daily with food (see Table 1) see Dosage and Administration (2.4)].
Table 1. Recommended Dosage in Patients 6 Years of Age and Older for the Treatment of DMD:
| Weight± | Dosage | Oral Suspension Volume |
|---|---|---|
| 10 kg to less than 20 kg | 22.2 mg twice daily | 2.5 mL twice daily |
| 20 kg to less than 40 kg | 31 mg twice daily | 3.5 mL twice daily |
| 40 kg to less than 60 kg | 44.3 mg twice daily | 5 mL twice daily |
| 60 kg or more | 53.2 mg twice daily | 6 mL twice daily |
± Based on actual body weight
DUVYZAT may cause adverse reactions [see Warnings and Precautions (5.1, 5.2, 5.3)], which may necessitate a dosage modification (see Table 2) if the following occur:
Based on the severity of these adverse reactions, treatment interruption prior to dosage modification should be considered.
Table 2. Dosage Modifications for Adverse Reactions in Patients 6 Years of Age and Older for the Treatment of DMD:
| First Dosage Modification* | Second Dosage Modification** | |||
|---|---|---|---|---|
| Weight± | Dosage | Oral Suspension Volume | Dosage | Oral Suspension Volume |
| 10 kg to less than 20 kg | 17.7 mg twice daily | 2 mL twice daily | 13.3 mg twice daily | 1.5 mL twice daily |
| 20 kg to less than 40 kg | 22.2 mg twice daily | 2.5 mL twice daily | 17.7 mg twice daily | 2 mL twice daily |
| 40 kg to less than 60 kg | 31 mg twice daily | 3.5 mL twice daily | 26.6 mg twice daily | 3 mL twice daily |
| 60 kg or more | 39.9 mg twice daily | 4.5 mL twice daily | 35.4 mg twice daily | 4 mL twice daily |
± Based on actual body weight
* If the adverse reaction(s) persist after the first dosage modification, proceed to the second dosage modification.
** If the adverse reaction(s) persist after the second dosage modification, DUVYZAT should be discontinued.
Withhold DUVYZAT if the QTc interval is >500 ms or the change from baseline is >60 ms [see Warnings and Precautions (5.4) and Drug Interactions (7.2)].
See the Instructions for Use for further details.
If a dose is missed, patients should not take double or extra doses.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Store upright.
Discard any unused DUVYZAT remaining after 60 days of first opening of the bottle.
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