Acute hepatic porphyria (AHP)

Active Ingredient: Givosiran

Indication for Givosiran

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

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:

2.5 mg/kg once monthly

Route of admnistration

Subcutaneous

Defined daily dose

2.5 - 2.5 mg per kg of body weight

Dosage regimen

From 2.5 To 2.5 mg per kg of body weight once every 30 day(s)

Detailed description

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.

Missed dose

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.

Dose modification for adverse reactions

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.

Dosage considerations

This medicinal product should be injected subcutaneously into the abdomen; alternative injection sites include the thigh or upper arm.

Active ingredient

Givosiran

Givosiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of aminolevulinic acid synthase 1 (ALAS1) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference, resulting in a reduction of induced liver ALAS1 mRNA towards normal. This leads to reduced circulating levels of neurotoxic intermediates aminolevulinic acid (ALA) and porphobilinogen (PBG), the key causal factors of attacks and other disease manifestations of AHP.

Read more about Givosiran

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