On 3 August 2026, the Therapeutic Goods Administration (TGA) announced it was undertaking a review of the benefits and risks of TAVNEOS (avacopan).
While this investigation has been underway, the Australian sponsor for the prescription medicine TAVNEOS (avacopan), CSL Seqirus, advised the TGA of their intent to withdraw the product from the Australian Register of Therapeutic Goods (ARTG). The withdrawal is expected to take effect on 31 March 2027. Information about the discontinuation of this product in Australia is published on the Medicine Shortage Reports Database.
Treating healthcare professionals should not initiate treatment of TAVNEOS (avacopan) in new patients, as per advice in the sponsor’s Dear Healthcare Professional Communication (DHPC).
Information for health professionals
The TGA advises health professionals that starting new patients is not recommended.
Patients and health professionals supervising patients continuing therapy or transitioning to alternative therapies should ensure they are aware of the known and potential risks associated with use of TAVNEOS (avacopan).
Health professionals should refer to the current Product Information (PI) for prescribing information, warnings and precautions. TAVNEOS (avacopan) is subject to additional monitoring requirements, due to the risk of liver injury. The PI for TAVNEOS (avacopan) contains the most up-to-date information on the known risks associated with the product.
Information for patients and health professionals
Patients currently receiving treatment with TAVNEOS (avacopan) should not stop treatment without first discussing their treatment options with their treating healthcare professional.
Consumers and health professionals are encouraged to report any suspected adverse events associated with TAVNEOS (avacopan) to the TGA. Adverse event reports contribute to the TGA's ongoing monitoring of the safety of medicines and can assist in the identification and investigation of potential safety signals. Consumers, health professionals and sponsors can find information on reporting an adverse event on the page Report an adverse event or safety problem.
The TGA will continue to monitor the situation and provide further updates if required.