Avacopan (Tavneos) is a complement 5a receptor (C5aR) antagonist. It is indicated for the treatment of severe active antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in adults, when used in combination with standard therapy including glucocorticoids.

How to Use Avacopan (Tavneos)

Recommended Administration Regimen

Dosage and Frequency: Take 30 mg (3 × 10 mg capsules) twice daily with meals. Capsules must be swallowed whole; do not crush, chew, or open them.

Management of Missed Doses: If a dose is missed, wait until the next scheduled dose time. Do not make up for the missed dose or double the dose.

Pre-Treatment Assessment

Liver Function Testing: Serum alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, and total bilirubin tests must be completed before treatment, and regular monitoring is required during treatment.

Hepatitis B Screening: All patients must undergo tests for hepatitis B surface antigen (HBsAg) and anti-hepatitis B core antibody (anti-HBc). If there is evidence of hepatitis B infection, the need for antiviral treatment should be evaluated under the guidance of a hepatologist.

Dosage Adjustment of Avacopan (Tavneos)

Impact of CYP3A4 Inhibitors

Strong Inhibitors (e.g., itraconazole): Adjust the Tavneos dosage to 30 mg once daily.

Moderate-to-Strong Inducers (e.g., rifampicin): Concomitant use should be avoided, as it may lead to a significant decrease in avacopan plasma concentration.

Adjustment for Abnormal Liver Function

ALT/AST > 3 × Upper Limit of Normal (ULN): Suspend administration and assess the cause.

ALT/AST > 5 × ULN or accompanied by elevated bilirubin: Discontinue the drug permanently until drug-induced liver injury is ruled out.

Use of Avacopan (Tavneos) in Special Populations

Pregnancy and Lactation

Pregnancy: Animal studies have shown that high doses may cause fetal rib abnormalities; use is contraindicated during pregnancy. Women of childbearing age must use contraception during treatment and for 6 months after discontinuing the drug.

Lactation: The drug may be excreted in breast milk. It is recommended to weigh the pros and cons before deciding to discontinue the drug or stop breastfeeding.

Pediatric and Geriatric Patients

Pediatric Patients: Efficacy has not been established; use is not recommended.

Geriatric Patients (≥ 65 years old): No dosage adjustment is required, but enhanced monitoring for infections is necessary.

Patients with Hepatic or Renal Impairment

Mild to Moderate Hepatic Impairment: No dosage adjustment is required, but close monitoring of liver function is necessary.

Severe Hepatic Impairment (Child-Pugh Class C): No study data are available; use should be avoided.

Renal Impairment: No dosage adjustment is required for mild to severe renal impairment, but data on dialysis patients are insufficient.

Patients at Risk of Infections

Active Infections: Delay drug administration until the infection is controlled.

Hepatitis B Carriers: The drug should be used under the protection of antiviral treatment, and HBV DNA should be monitored.

Vaccination

Live Vaccines: Complete vaccination 4 weeks before treatment; live vaccines are contraindicated during treatment.