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Anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis Clinical criteria: Treatment Phase: Induction treatment The condition must be severe granulomatosis with polyangiitis; OR The condition must be severe microscopic polyangiitis, AND The condition must be active at the time of the first prescription for this drug per treatment cycle, AND Patient must have ANCA associated vasculitis that is either: (i) organ-threatening, (ii) life-threatening disease, AND Patient must be undergoing concomitant therapy with at least another drug therapy as part of a regimen specified in this drug's approved Product Information, AND Patient must not receive more than 12 months of PBS-subsidised treatment with this drug per induction. A prescriber may apply for more than one induction treatment for their patient
“Avacopan is a selective antagonist of the human complement 5a receptor (C5aR1 or CD88) and competitively inhibits the interaction between C5aR1 and the anaphylatoxin C5a.”
“The median terminal elimination half-life is 510 hours (21 days) based on population pharmacokinetic analysis.”
“Cytochrome P450 (CYP) 3A4 is the major enzyme responsible for the clearance of avacopan and for the formation and clearance of the major circulating metabolite M1, a mono-hydroxylated product of avacopan. Avacopan is a moderate inhibitor of CYP3A4 based on a 2.57-fold increase in the AUC of the probe active substance simvastatin in the presence of avacopan administered with food.”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.