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    * Trial Design
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TARGET THE ALTERNATIVE COMPLEMENT PATHWAY1

SEE HOW FABHALTA WORKS

View MOA

SEE TRIAL RESULTS FOR FABHALTA

View efficacy

EXPLORE THE SAFETY PROFILE FOR FABHALTA

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IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

FABHALTA, a complement inhibitor, increases the risk of serious infections,
especially those caused by encapsulated bacteria, such as Streptococcus
pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b.
Life-threatening and fatal infections with encapsulated bacteria have occurred
in patients treated with complement inhibitors. These infections may become
rapidly life threatening or fatal if not recognized and treated early.

 * Complete or update vaccinations for encapsulated bacteria at least 2 weeks
   prior to the first dose of FABHALTA, unless the risks of delaying therapy
   with FABHALTA outweigh the risk of developing a serious infection. Comply
   with the most current Advisory Committee on Immunization Practices (ACIP)
   recommendations for vaccinations against encapsulated bacteria in patients
   receiving a complement inhibitor.

 * Patients receiving FABHALTA are at increased risk for invasive disease caused
   by encapsulated bacteria, even if they develop antibodies following
   vaccination. Monitor patients for early signs and symptoms of serious
   infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria,
FABHALTA is available only through a restricted program under a Risk Evaluation
and Mitigation Strategy (REMS) called the FABHALTA REMS.

INDICATION

FABHALTA is indicated to reduce 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.

CLICK OR SCROLL TO SEE IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING AND
INDICATION

DEFINITIONS AND REFERENCE



Definitions
IgAN, immunoglobulin A nephropathy; MOA, mechanism of action; UPCR, urine
protein-to-creatinine ratio.

Reference
1. Fabhalta. Prescribing information. Novartis Pharmaceuticals Corp.

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