Overview
Fabhalta is approved by the U.S. Food and Drug Administration (FDA) to reduce proteinuria (excess protein in urine) in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. The approval for IgAN is under the FDA’s accelerated approval program based on reduction of proteinuria. The drug is available only through a Risk Evaluation and Mitigation Strategy (REMS) program.  According to the drug’s prescribing information, it has not been established whether Fabhalta slows kidney function decline in these individuals, and continued approval may depend on confirmatory clinical trial results. Fabhalta is also known by its drug name, iptacopan.

Fabhalta is a complement factor B inhibitor. It works by blocking a part of the immune system called the alternative complement pathway, which is believed to contribute to kidney inflammation and damage in IgAN. By reducing this immune activity, Fabhalta helps lower protein levels in the urine.

How do I take it?
Prescribing information states that Fabhalta is taken as an oral capsule twice daily, with or without food. It should be taken exactly as prescribed by a health care provider.

Side effects
Common side effects of Fabhalta include upper respiratory tract infection, lipid disorder (abnormal blood fat levels), and abdominal pain.

Rare but serious side effects may include life-threatening infections caused by encapsulated bacteria such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These infections can occur even in people who have been vaccinated. Other serious risks include high cholesterol levels and possible complications if the drug is stopped suddenly, such as worsening of the underlying kidney condition.

For more information about this treatment, visit:

Fabhalta (Iptacopan) Capsules, for Oral Use — Novartis Pharmaceuticals