AVACOPAN CAP,ORAL

Clinical Criteria Summary

Adjunctive treatment of adult patients with severe active ANCA-associated vasculitis (AAV) (GPA and MPA) in combination with standard therapy including glucocorticoids
Not approved for eosinophilic granulomatosis with polyangiitis (EGPA / Churg-Strauss syndrome)
VA-specific indication: Patients with severe (organ- or life-threatening), active, newly diagnosed or relapsing ANCA-positive GPA or MPA who require rapid reduction of glucocorticoid therapy due to severe, otherwise unmanageable glucocorticoid-induced complications or toxicity (e.g., glucocorticoid-related psychosis, myopathy, or herpetic keratitis)
Not intended for adding to existing therapy with the intent of reducing relapse risk in patients already in remission
Not intended for improving remission induction or maintenance when current guideline-recommended induction or maintenance therapy is already in place

30 mg (three 10-mg capsules) twice daily with food
Capsules must not be crushed, chewed, or opened
Reduce dosage to 30 mg once daily when coadministered with strong CYP3A4 inhibitors
No dosage adjustment required for mild, moderate, or severe renal impairment; no data available for patients on dialysis
No dosage adjustment required for mild or moderate hepatic impairment; no data available for severe (Child-Pugh Class C) hepatic impairment

Obtain liver function tests including serum ALT, AST, alkaline phosphatase, and total bilirubin prior to initiation
Obtain Hepatitis B serology (HBsAg and anti-HBc titers) prior to initiation; consult HBV management expert if results indicate prior or current infection to determine need for antiviral therapy and establish monitoring plan
Monitor liver tests every 4 weeks for the first 6 months, then as clinically indicated
Withhold treatment if ALT or AST > 3x ULN; discontinue if AST or ALT > 5x ULN or if AST/ALT > 3x ULN with TBIL > 2x ULN until avacopan-induced liver injury is ruled out
Monitor for evidence of HBV reactivation during therapy and for 6 months after completion of therapy
Closely monitor for evidence of infection during and after therapy; interrupt therapy if serious or opportunistic infection develops and resume once infection is controlled

Contraindicated in patients with serious hypersensitivity to avacopan or product excipients
Not recommended for use in patients with:
• Active, untreated and/or uncontrolled chronic liver disease and cirrhosis
• Active, serious, systemic or localized infection (including undrained abscess); may initiate/restart once controlled
• Untreated latent or active tuberculosis infection
• HBsAg-positive status without antiviral prophylaxis; may initiate after starting prophylaxis
• HBsAg-negative but anti-HBc-positive status; may initiate after starting prophylaxis or if expert approves proceeding without it
• Hemodialysis dependence
• Concomitant use of strong and moderate CYP3A4 inducers
Avoid coadministration with strong and moderate CYP3A4 inducers
Not recommended for use with methotrexate due to potential additive risk of hepatotoxicity, despite not being a formal contraindication in prescribing information

If continued during remission of severe disease, use concurrently with standard maintenance therapy (rituximab, azathioprine, or mycophenolate) for a duration based on clinician discretion (e.g., up to 1 to 2 years)
Discontinue avacopan when current guideline-recommended maintenance therapy is withdrawn (e.g., up to 2 years)
Efficacy of avacopan monotherapy is unknown; should not be used as a replacement for glucocorticoids

Must be prescribed by rheumatologists, nephrologists, or other locally designated clinicians with expertise in the management of AAV

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