Tavneos (avacopan) and TGA medicine safety updates — 11 September 2026

Tavneos (avacopan)

Swissmedic has issued a Direct Healthcare Professional Communication on Tavneos (avacopan). Major Good Clinical Practice violations invalidate the efficacy results of the ADVOCATE study, while hepatotoxicity concerns further weaken the benefit–risk balance. The marketing authorisation is scheduled for revocation on 30 November 2026; no new patients should be started and current patients should be reviewed with consideration of alternatives.

TGA Product Information safety updates — August 2026

TGA’s update published on 11 September 2026 lists 35 product-information changes. Clinically important examples include clozapine appendicitis/perforation and myocarditis warnings with valproate; propofol infusion syndrome; glofitamab-associated HLH and PML; Xultophy and NAION; amoxicillin/clavulanate crystalluria and acute kidney injury; azathioprine PRES; dabrafenib/trametinib radiation recall; metformin safety warnings; and tucatinib hepatotoxicity monitoring.

Sources

• Swissmedic — Tavneos (avacopan) DHPC
• TGA — Product Information safety updates, August 2026