Fabhalta (Iptacopan) for Kidney Disease

Overview
Fabhalta is approved by the U.S. Food and Drug Administration (FDA) for the reduction of proteinuria (excess protein in the urine) in adults with primary immunoglobulin A nephropathy (IgAN), a condition that can lead to kidney damage. To qualify for this treatment, a person must be at risk of rapid disease progression, typically indicated by a urine protein-to-creatinine ratio (UPCR) of at least 1.5 grams per gram. Approval for this use is based on its ability to reduce proteinuria, but more studies are needed to prove it helps slow kidney damage. 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 complement system, which is thought to contribute to kidney damage in IgAN. This helps reduce inflammation and protein leakage into the urine.

How do I take it?
Prescribing information states that Fabhalta is taken orally (by mouth) as a capsule. It’s typically taken 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 when used to treat IGaN include upper respiratory tract infections, lipid disorders (abnormal blood fat levels), and abdominal (stomach area) pain.

Rare but serious side effects may include severe infections caused by encapsulated bacteria such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. Prescribing information states that a person should be vaccinated against these bacteria before starting treatment and monitored for early signs of infection.

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Label: Fabhalta — Iptacopan Capsule — DailyMed