Primary hyperoxaluria type 1 (PH1)

Active Ingredient: Lumasiran

Indication for Lumasiran

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

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:

3-6 mg/kg once a month

Route of admnistration

Subcutaneous

Defined daily dose

3 - 6 mg per kg of body weight

Dosage regimen

From 3 To 6 mg per kg of body weight once every 30 day(s)

Detailed description

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 months3 mg/kg once monthly
10 kg to less than 20 kg6 mg/kg once monthly for 3 months6 mg/kg once every 3 months (quarterly)
20 kg and above 3 mg/kg once monthly for 3 months3 mg/kg once every 3 months

Missed dose

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.

Dosage considerations

It should be injected subcutaneously into the abdomen, upper arms, or thighs.

Active ingredient

Lumasiran

Lumasiran is a double-stranded small interfering ribonucleic acid (siRNA) that reduces levels of glycolate oxidase (GO). Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production. This results in reduction of urinary and plasma oxalate levels, the underlying cause of disease manifestations in patients with primary hyperoxaluria type 1 (PH1).

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