Active Ingredient: Givosiran
Givosiran is indicated for the treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
2.5 - 2.5 mg per kg of body weight
From 2.5 To 2.5 mg per kg of body weight once every 30 day(s)
The recommended dose of Givlaari is 2.5 mg/kg once monthly, administered via subcutaneous injection. Dosing is based on actual body weight. The patient dose (in mg) and volume (in mL) should be calculated as follows:
Patient body weight (kg) × dose (2.5 mg/kg) = total amount (mg) of medicinal product to be administered.
If a dose is missed, treatment should be administered as soon as possible. Dosing should be resumed at monthly intervals following administration of the missed dose.
In patients with clinically relevant transaminase elevations, who have dose interruption and subsequent improvement in transaminase levels, a dose resumption at 1.25 mg/kg once monthly could be considered.
This medicinal product should be injected subcutaneously into the abdomen; alternative injection sites include the thigh or upper arm.
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