Information for Patients Taking Tavneos (avacopan) for ANCA-Associated Vasculitis

On March 31, the Food & Drug Administration (FDA) issued a drug safety communication reporting on serious, including fatal, cases of drug-induced liver injury (DILI) associated with Tavneos (avacopan). This medicine is prescribed to people with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis and microscopic polyangiitis, two conditions that can cause damage to the kidneys. 

According to the FDA, some cases involve vanishing bile duct syndrome (VBDS), which can slow or stop the flow of bile and may lead to permanent liver damage. VBDS and DILI cases with fatal outcomes represent new safety concerns, according to the FDA drug safety communication. 

The FDA is continuing to monitor cases of DILI, including VBDS. Per FDA guidance, doctors should more frequently monitor liver function tests of patients who are starting or have recently started avacopan. 

We encourage patients to review the information on the FDA website, which directs patients to contact their health care professional immediately if they develop any signs or symptoms that may indicate liver injury. These may include:

• feeling more tired than usual
• nausea
• vomiting
• unusual itching
• light-colored stools
• yellowing of skin or eyes
• dark urine
• swelling in the stomach or abdomen
• pain in the right upper abdomen

In addition to advising patients to review the FDA information, we also advise them to review information on Amgen's website, which has been providing updates for patients, at the following link:  https://www.amgen.com/tavneos-update.

This is not medical advice and is not intended to replace the advice of a patient's physician. Patients with questions about this medicine should consult their health care team.