What is the most important information I should know about FABHALTA?

FABHALTA is a medicine that affects part of your immune system and may lower your ability to fight infections.

• FABHALTA increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. These serious infections may quickly become life-threatening or fatal if not recognized and treated early.
  • You must complete or update your vaccinations against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of FABHALTA.

What is FABHALTA?
FABHALTA is a prescription medicine used to:

• Treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
• Reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease progressing quickly.

FABHALTA is approved based on a reduction of proteinuria. Continued approval may require results from an ongoing study to determine whether FABHALTA slows decline in kidney function.

• Treat adults with a kidney disease called complement 3 glomerulopathy (C3G), to reduce protein in the urine (proteinuria).

It is not known if FABHALTA is safe and effective in children with PNH, IgAN, or C3G.