Active Ingredient: Nedosiran
Nedosiran is indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥30 mL/min/1.73 m².
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 50 kg, subcutaneous, 160 milligrams nedosiran, once monthly.
Regimen B: In case that patient weight is ≤ 50 kg, subcutaneous, 128 milligrams nedosiran, once monthly.
Nedosiran is administered subcutaneously once monthly at the recommended doses shown in the table below.
Dosing is based on actual body weight.
Nedosiran dose regimen:
| Age | Body Weight | Dosing Regimen |
|---|---|---|
| Adults and adolescents 12 years and older | Greater than or equal to 50 kg | 160 mg once monthly |
| Less than 50 kg | 128 mg once monthly |
If a planned dose is missed, administer nedosiran as soon as possible. If the planned dose is missed by more than 7 days, administer nedosiran as soon as possible and resume monthly dosing from the most recently administered dose.
Administer nedosiran by subcutaneous injection to the abdomen (at least 2 inches from the navel) or the upper thigh. Do not inject into a vein or into scarred or bruised skin.
For:
Regimen A: In case that patient age in years is ≥ 9 and patient weight is ≥ 50 kg, subcutaneous, 160 milligrams nedosiran, once monthly.
Regimen B: In case that patient age in years is ≥ 9 and patient weight is ≤ 50 kg, subcutaneous, 3.3 milligrams nedosiran per kilogram of body weight, once monthly.
Nedosiran is administered subcutaneously once monthly at the recommended doses shown in the table below.
Dosing is based on actual body weight.
Nedosiran dose regimen:
| Age | Body Weight | Dosing Regimen |
|---|---|---|
| Children 9 to 11 years | Greater than or equal to 50 kg | 160 mg once monthly |
| Less than 50 kg | 3.3 mg/kg once monthly, not to exceed 128 mg |
If a planned dose is missed, administer nedosiran as soon as possible. If the planned dose is missed by more than 7 days, administer nedosiran as soon as possible and resume monthly dosing from the most recently administered dose.
Administer nedosiran by subcutaneous injection to the abdomen (at least 2 inches from the navel) or the upper thigh. Do not inject into a vein or into scarred or bruised skin.
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