Safety profile of FABHALTA® (iptacopan)
Serious risk of infections
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.1
Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is available only through a restricted program under a REMS called the FABHALTA REMS.1
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Contraindications
FABHALTA is contraindicated:
- In patients with serious hypersensitivity to FABHALTA or any of the excipients1
- For initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b1
Safety profile of FABHALTA in the APPLAUSE clinical trial1
These data reflect exposure in patients with IgAN (eGFR ≥20 mL/min/1.73 m2 at baseline). The median duration of exposure to FABHALTA was 102 weeks (up to 107 weeks)
ADVERSE REACTIONS REPORTED IN ≥3% OF ADULT PATIENTS WITH IgAN TREATED WITH FABHALTA AND ≥2% HIGHER IN FREQUENCY THAN PLACEBO IN APPLAUSE
aIncludes similar terms.
Serious infections caused by encapsulated bacteria reported in APPLAUSE-IgAN occurred in 3 patients (1.2%) on FABHALTA and none on placebo.
Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is only available through a REMS program that requires vaccinations.1 See Getting Started for more details.
See trial results for FABHALTA
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