Tavneos (avacopan): FDA identifies serious liver injury cases
FDA identified cases of serious liver injury, including drug-induced liver injury (DILI) with hepatic failure, in patients taking Tavneos (avacopan) for severe active ANCA-associated vasculitis. Updated labelling now includes enhanced liver monitoring requirements and guidance on when to discontinue therapy.
Avacopan (PubChem) ↗ is an oral complement C5a receptor antagonist approved in 2021 as adjunctive treatment to standard therapy for AAV. It works by blocking the inflammatory complement pathway that drives vascular inflammation in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Approval was based on the ADVOCATE trial (NEJM) ↗, which showed non-inferiority and superiority to prednisone on sustained remission.
Monitoring guidance
Updated labelling requires liver function tests (ALT, AST, bilirubin) before starting Tavneos, then monthly for the first 6 months, and as clinically indicated thereafter. Prescribers should discontinue Tavneos if significant hepatic injury is suspected. Patients should be advised to report symptoms of liver problems including jaundice, dark urine, abdominal pain, or fatigue. Report adverse events to FDA MedWatch ↗.
FAQ
Does a Boxed Warning mean a drug is being withdrawn?
No. A Boxed Warning ↗ (also called a Black Box Warning) is the FDA's strongest label caution, but the drug remains on the market. It means the agency has determined that a risk is serious enough to require prominent, standardised labelling. The drug continues to be prescribed under appropriate clinical conditions. See the FDA's patient guide to Boxed Warnings ↗.
Where can I read the full updated label?
All current FDA-approved prescribing information is available on DailyMed ↗, maintained by the National Library of Medicine (NLM). Search by drug name to find the most recent label version. Historical label versions are also archived there.