Other safety alerts
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| European Union: Tavneos (avacopan): reinforced liver function monitoring requirements and stopping rules to mitigate risk of serious liver injury |
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European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) has endorsed a DHPC to inform healthcare professionals of its recommendations to reinforce liver function monitoring requirements and stopping rules for Tavneos (avacopan) to mitigate the known risk of drug-induced liver injury (DILI) and vanishing bile duct syndrome (VBDS). VBDS is a rare condition where the small bile ducts inside the liver are gradually damaged and disappear over time.
Tavneos is used to treat adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two rare inflammatory conditions of the blood vessels.
The updated recommendations follow further characterisation of the risk of DILI and VBDS in light of recent reports of serious liver injury, including cases with a fatal outcome.
Before starting treatment with Tavneos, liver function tests, including hepatic transaminases and total bilirubin (key indicators of liver function), must be performed. During treatment, liver function must be monitored at least every two weeks after the start of therapy for the first three months, followed by every four weeks for the next three months of treatment, and as clinically indicated thereafter.
Treatment with Tavneos must be stopped if blood levels of alkaline phosphatase (ALP, another indicator of liver function) are over twice the normal limit when the source of increased ALP is the liver, or when there are clinical symptoms of VBDS such as jaundice (yellowish appearance of the skin and the whites of the eyes) or itching. If VBDS is suspected, treatment must be immediately and permanently stopped. This is in addition to stopping rules already included in the product information.
EMA is also conducting a review of Tavneos, prompted by questions regarding data integrity of the main study. More information is available on the EMA website.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-june-2026
In Hong Kong, the above product is not a registered pharmaceutical product.
Related news on the risk of serious liver injury associated with the use of Tavneos (avacopan) was previously issued by the US Food and Drug Administration (FDA), and was posted on the Drug Office website on 1 April 2026.
Ends/Saturday, June 13, 2026
Issued at HKT 12:00
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