Skip to content
English
Sign in
Contact us
  • There are no suggestions because the search field is empty.

Medication Information: Fabhalta

Brand name: Fabhalta

Generic name: Iptacopan

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.

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.
    • If you have not completed your vaccinations and FABHALTA must be started right away, you should receive the required vaccinations as soon as possible.
    • If you have not been vaccinated and FABHALTA must be started right away, you should also receive antibiotics to take for as long as your health care provider tells you.
    • If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting FABHALTA. Your health care provider will decide if you need additional vaccinations.
    • Vaccines do not prevent all infections caused by encapsulated bacteria. Call your health care provider or get emergency medical care right away if you have any of these signs and symptoms of a serious infection:
      • Fever with or without shivers or chills
      • Fever with chest pain and cough
      • Fever with high heart rate
      • Headache and fever
      • Confusion
      • Clammy skin
      • Fever and rash
      • Fever with breathlessness or fast breathing
      • Headache with nausea or vomiting
      • Headache with stiff neck or stiff back
      • Body aches with flu-like symptoms
      • Eyes sensitive to ligh