Active Ingredient: Givinostat
Givinostat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in the case that patient age in years is ≥ 6 and patient weight is ≥ 15 kg and patient weight is < 20 kg :
Oral, 22.2 milligrams givinostat, 2 times daily.
Regimen B, in the 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 the 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 the case that patient age in years is ≥ 6 and patient weight is ≥ 60 kg :
Oral, 53.2 milligrams givinostat, 2 times daily.
Baseline platelet counts and triglycerides should be obtained and evaluated prior to initiation of givinostat. Givinostat should not be initiated in patients with a platelet count less than 150 x 109/l. Platelet counts and triglycerides should be monitored as recommended during treatment to determine if dosage modifications are needed (see dose adjustment instructions below).
In addition, in patients with underlying cardiac disease or taking concomitant medicines that cause QT prolongation, an ECG should be obtained when initiating treatment with givinostat, during concomitant use, and as clinically indicated.
The recommended dose of givinostat is based on body weight and should be administered orally twice daily (see Table 1).
Table 1. Recommended Dosage:
| Weighta | Dosage |
|---|---|
| 15 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 |
a Based on actual body weight
The decision to continue treatment in patients who become non-ambulatory should be taken at the discretion of the physician based on the overall benefit and risk assessment.
A dose reduction (see Table 2) should be applied for patient with:
or
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:
| First Dosage Modificationb | Second Dosage Modificationc | |
|---|---|---|
| Weighta | Dosage | Dosage |
| 15 kg to less than 20 kg | 17.7 mg twice daily | 13.3 mg twice daily |
| 20 kg to less than 40 kg | 22.2 mg twice daily | 17.7 mg twice daily |
| 40 kg to less than 60 kg | 31 mg twice daily | 26.6 mg twice daily |
| 60 kg or more | 39.9 mg twice daily | 35.4 mg twice daily |
a Based on actual body weight
b If the adverse reaction(s) persist after the first dosage modification, proceed to the second dosage modification.
c If the adverse reaction(s) persist after the second dosage modification, givinostat should be discontinued.
Patients should not take a double or extra dose if a dose is missed.
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