Active Ingredient: Givinostat
Givinostat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in years is ≥ 6 and patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, oral, 22.2 milligrams givinostat, 2 times daily.
Regimen B: In case that patient age in years is ≥ 6 and patient weight is ≥ 20 kg and patient weight is ≤ 40 kg, oral, 31 milligrams givinostat, 2 times daily.
Regimen C: In case that patient age in years is ≥ 6 and patient weight is ≥ 40 kg and patient weight is ≤ 60 kg, oral, 44.3 milligrams givinostat, 2 times daily.
Regimen D: In case that patient age in years is ≥ 6 and patient weight is ≥ 60 kg, oral, 53.2 milligrams givinostat, 2 times daily.
Obtain and evaluate baseline platelet counts and triglycerides prior to initiation of givinostat. Do not initiate givinostat 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.
In addition, in patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs when initiating treatment with givinostat, during concomitant use, and as clinically indicated.
The recommended dosage of givinostat is based on body weight and administered orally twice daily with food (see Table 1).
Table 1. Recommended dosage in patients 6 years of age and older for the treatment of DMD:
| Weight± | Dosage |
|---|---|
| 10 kg to less than 20 kg | 22.2 mg twice daily |
| 20 kg to less than 40 kg | 31 mg twice daily |
| 40 kg to less than 60 kg | 44.3 mg twice daily |
| 60 kg or more | 53.2 mg twice daily |
± Based on actual body weight
Givinostat may cause adverse reactions, which may necessitate a dosage modification (see Table 2) if the following occur:
*Moderate or severe diarrhea or
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, givinostat should be discontinued.
Withhold givinostat if the QTc interval is >500 ms or the change from baseline is >60 ms.
If a dose is missed, patients should not take double or extra doses.
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