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Important Safety Information
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.
Approved Uses
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 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.
It is not known if FABHALTA is safe and effective in children with PNH or IgAN.
Click or scroll to see IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING, AND APPROVED USE