Fabhalta (Iptacopan) for Kidney Disease

Overview
Fabhalta is approved by the U.S. Food and Drug Administration (FDA) to reduce proteinuria (excess protein in the urine) in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. This is typically defined as having a urine protein-to-creatinine ratio (UPCR) of at least 1.5 grams per gram. This indication is approved under accelerated approval based on its ability to reduce proteinuria. It has not yet been proven that Fabhalta slows kidney function decline. Continued approval may depend on results from ongoing studies. Fabhalta is also approved to reduce proteinuria in adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. Fabhalta is also known by its drug name, iptacopan.

Fabhalta is a complement factor B inhibitor. It works by blocking part of the immune system known as the complement system, which is believed to cause inflammation and kidney damage in IgAN and C3G. By reducing this immune activity, Fabhalta helps lower the amount of protein leaking 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 IgAB include upper respiratory tract infections, lipid disorders (abnormal levels of fats in the blood), and abdominal (stomach area) pain.

Common side effects of Fabhalta when used to treat C3G include nasopharyngitis (inflammation of the nose and throat) and viral infections.

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. People must be vaccinated against these bacteria at least two weeks before starting treatment, unless the risk of delaying treatment is greater than the risk of infection. Even after vaccination, serious infections can still occur. People taking Fabhalta should be closely monitored for early signs of infection. Fabhalta is only available through a restricted program called the Fabhalta Risk Evaluation and Mitigation Strategy (REMS).

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Prescribing Information: Fabhalta (Iptacopan) Capsules, for Oral Use — Novartis