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Label indication EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria. FDA label
Also known as Aspaveli, Empaveli, APL-2
Pegcetacoplan · 1 trial · 5 indications
Occurrence of clinically significant recurrent C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) following kidney transplantation.
| Arm | Type | Description |
|---|---|---|
| Pegcetacoplan | EXPERIMENTAL | Pegcetacoplan, a complement C3/C3b inhibitor, administered according to the study protocol in kidney transplant recipients with high risk of recurring C3G or primary IC-MPGN |
| Name | Type | Description |
|---|---|---|
| Pegcetacoplan | DRUG | Dose amount based on age and weight Subcutaneous infusion twice-a-week. Adult participants aged 18 years or older at enrolment: 1080 mg Adolescent participants aged 12 to 17 years at enrolment: * Weight ≥50 kg: 1080 mg * Weight 35 to \<50 kg: 648 mg 1st dose, then 810 mg subsequently * Weight 30 to \<35 kg: 540 mg for the first 2 doses, then 648 mg subsequently |
Inclusion Criteria: * Male or female patients with a diagnosis of C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) who are planning to undergo kidney transplantation because of the disease. * High risk of disease recurrence following kidney transp...