Active Ingredient: Risdiplam
Risdiplam is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 0.2 milligrams risdiplam per kilogram of body weight, once daily.
2 months to <2 years of age:
Recommended daily dose: 0.20 mg/kg.
Risdiplam is taken orally once a day after a meal at approximately the same time each day, using the reusable oral syringe provided. In infants who are breastfed, risdiplam should be administered after breastfeeding. Risdiplam should not be mixed with milk or formula milk.
Risdiplam should be taken immediately after it is drawn up into the oral syringe. If it is not taken within 5 minutes, it should be discarded from the oral syringe and a new dose be prepared. If risdiplam spills or gets on the skin, the area should be washed with soap and water.
For:
Regimen A: In case that patient weight is ≤ 20 kg, oral, 0.25 milligrams risdiplam per kilogram of body weight, once daily.
Regimen B: In case that patient weight is ≥ 20 kg, oral, 5 milligrams risdiplam, once daily.
The recommended once daily dose of risdiplam is determined by age and body weight.
Dosing regimen by age and body weight:
| Age and body weight | Recommended daily dose |
|---|---|
| ≥2 years of age (<20 kg) | 0.25 mg/kg |
| ≥2 years of age (≥20 kg) | 5 mg |
Treatment with a daily dose above 5 mg has not been studied.
Risdiplam is taken orally once a day after a meal at approximately the same time each day, using the reusable oral syringe provided. Risdiplam should not be mixed with milk or formula milk.
Risdiplam should be taken immediately after it is drawn up into the oral syringe. If it is not taken within 5 minutes, it should be discarded from the oral syringe and a new dose be prepared. If risdiplam spills or gets on the skin, the area should be washed with soap and water.
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