FABHALTA Manuals & User Guides

FABHALTA Iptacopan Capsules Overview FABHALTA (iptacopan) is a complement factor B inhibitor indicated for adults with paroxysmal nocturnal hemoglobinuria (PNH), IgA nephropathy (IgAN), and complement 3 glomerulopathy (C3G). It carries…

FABHALTA Risk Evaluation and Mitigation Strategy Product Specifications Risk: serious infections caused by encapsulated bacteria Application Number: NDA 218276 Application Holder: Novartis Pharmaceuticals Corporation Initial REMS Approval: 12/2023 Most Recent…

FABHALTA 5426117 Risk Evaluation and Mitigation Strategy Specifications Product Name: FABHALTA (iptacopan) Intended Use: Treatment of paroxysmal nocturnal hemoglobinuria (PNH) and proteinuria in primary immunoglobulin A nephropathy (IgAN) Risk: Lowered…

Official prescribing information and medication guide for FABHALTA (iptacopan), a complement factor B inhibitor indicated for the treatment of PNH, IgAN, and C3G.

This document outlines the Risk Evaluation and Mitigation Strategy (REMS) for FABHALTA® (iptacopan), detailing requirements for healthcare providers, patients, and pharmacies to mitigate the risk of serious infections caused by…