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Empaveli(Pegcetacoplan)

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Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

EMPAVELI® (pegcetacoplan) is a complement inhibitor approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adult patients. PNH is a rare, acquired disorder characterized by hemolysis (destruction of red blood cells), which can lead to serious complications, including severe anemia, fatigue, and the need for frequent blood transfusions. EMPAVELI® works by inhibiting the complement system, specifically C3, which is a key component in the immune response that contributes to the destruction of red blood cells in PNH.

The drug is administered subcutaneously, with the recommended dose of 1,080 mg twice a week. Patients must be vaccinated against certain encapsulated bacteria before starting therapy. While EMPAVELI® provides significant clinical benefits in reducing hemolysis and transfusion requirements, careful monitoring for serious infections and infusion-related reactions is essential during treatment.

Generic name

Empaveli(Pegcetacoplan)

English name

Pegcetacoplan

Alternative Names

Empaveli

Drug prices

Indications

EMPAVELI is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adult patients. PNH is a rare hematologic disorder characterized by the destruction of red blood cells, leading to anemia, fatigue, and an increased risk of thrombosis.

Therapeutic Target

EMPAVELI targets the complement system, specifically the C3 component, to inhibit the excessive activation of the complement cascade, which contributes to the pathophysiology of PNH.

Active Ingredients

pegcetacoplan

Dosage form

SOLUTION

specifications

EMPAVELI is packaged as a single-dose vial, containing 1,080 mg/20 mL (54 mg/mL) of pegcetacoplan.

Description

EMPAVELI (pegcetacoplan) is a complement inhibitor that works by selectively inhibiting C3, a key component of the complement system. By inhibiting the activity of C3, EMPAVELI reduces the process of hemolysis in patients with PNH, thereby improving the patient’s overall health status. It is administered subcutaneously and is part of a restricted distribution program, known as the EMPAVELI REMS program, due to potential risks associated with its use, including serious infections caused by encapsulated bacteria.

Dosage and Administration

1.Recommended Dosage: The recommended dosage of EMPAVELI is 1,080 mg administered subcutaneously twice weekly.

2.Administration Devices: EMPAVELI can be administered either via a commercially available pump or the EMPAVELI Injector.

3.Preparation and Administration Instructions: Detailed instructions for preparation and administration are available in the full prescribing information.

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