Fabhalta (Iptacopan)

• Complete or update vaccination 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. See

  Warnings and Precautions (5.1)

  for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria.
• 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.

FABHALTA is a complement factor B inhibitor, indicated for:

• the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). (
  1.1     Paroxysmal Nocturnal Hemoglobinuria

  FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
  )
• the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. (
  1.2     Immunoglobulin A Nephropathy

  FABHALTA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.

  This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether FABHALTA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
  )
  
  This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether FABHALTA slows kidney function decline in patients with IgAN.
  
  Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
• the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria. (
  1.3     Complement 3 Glomerulopathy

  FABHALTA is indicated for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.
  )

200 mg orally twice daily with or without food. (

Capsules: 200 mg of iptacopan in pale yellow, opaque, hard gelatin capsules imprinted with “LNP200” on the body and “NVR” on the cap.

• Severe hepatic impairment: Use not recommended. (
  8.7     Hepatic Impairment

  The use of FABHALTA is not recommended in patients with severe hepatic impairment (Child-Pugh class C). No dose adjustment is required for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment

  [see Clinical Pharmacology (12.3)]

  .
  )