Description
FABHALTA is a complement factor B inhibitor, indicated for:
• The treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
• The reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on
reduction of proteinuria. It has not been established whether FABHALTA slows kidney function decline in patients with IgAN.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
• The treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.
Additional information
| Brand | FABHALTA |
|---|---|
| Generic name | Iptacopan capsules |
| Form | Oral capsules |
| Strength | 200mg |
| Packing | 56's/Pack |
| Manufacturer | Novartis |
| Documents | Either PO or prescription |
| Storage | below 30°C temperature |
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