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Start with FABHALTA—a groundbreaking PNH treatment

Groundbreaking hemoglobin (Hb) improvements with the first and only FDA-approved oral monotherapy for adults with PNH. Primary end points (FABHALTA vs C5 inhibitors [C5is]): response rates for sustained Hb increase of ≥2 g/dL: 82.3% (N=62) vs 0% (N=35) with C5is (difference: 81.5; 95% CI, 71.6-91.4; P<0.0001). Response rates for sustained Hb of ≥12 g/dL: 67.7% (N=62) vs 0% (N=35) with C5is (difference: 66.6; 95% CI, 54.6-78.6; P<0.0001). Both end points were measured in the absence of red blood cell transfusions after 24 weeks. Differences reflect an adjusted difference in proportion.1    
Learn more about FABHALTA data in C5i-experienced patients

FABHALTA is an FDA-approved treatment for adults with PNH. FABHALTA has displayed efficacy in C5i-experienced and complement inhibitor–naive patients with PNH.1 

FABHALTA (Fab-HALT-ah) describes a Factor B inhibitor (FAB) of the alternative pathway (ALTA) of the complement system.1

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 for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

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Definitions 
C5i, C5 inhibitor; Hb, hemoglobin; PNH, paroxysmal nocturnal hemoglobinuria. 

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