Active Ingredient: Lumasiran
Lumasiran is indicated for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
3 - 6 mg per kg of body weight
From 3 To 6 mg per kg of body weight once every 30 day(s)
Lumasiran is administered by subcutaneous injection. The recommended dose of lumasiran consists of loading doses given once a month for 3 months, followed by maintenance doses, as shown in Table 1. Dosing is based on body weight.
The patient dose (in mg) and volume (in mL) should be calculated as follows:
Patient body weight (kg) × dose (mg/kg) = total amount (mg) of medicinal product to be administered.
Total amount (mg) divided by concentration (189 mg/mL) = total volume of medicinal product (mL) to be injected.
Table 1. Lumasiran weight-based dosing regimen:
| Body weight | Loading dose | Maintenance dose (the maintenance dose should begin one month after the last loading dose) |
|---|---|---|
| less than 10 kg | 6 mg/kg once monthly for 3 months | 3 mg/kg once monthly |
| 10 kg to less than 20 kg | 6 mg/kg once monthly for 3 months | 6 mg/kg once every 3 months (quarterly) |
| 20 kg and above | 3 mg/kg once monthly for 3 months | 3 mg/kg once every 3 months |
If a dose is delayed or missed, treatment should be administered as soon as possible. Prescribed monthly or quarterly dosing should be resumed from the most recently administered dose.
It should be injected subcutaneously into the abdomen, upper arms, or thighs.
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