Avacopan (Tavneos) is a complement 5a receptor (C5aR) antagonist, used as adjunctive therapy for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in adults.

Avacopan (Tavneos) Medication Precautions

Contraindication Screening

Severe Allergic Reactions: Contraindicated in patients allergic to avacopan or any of its excipients.

Active Hepatitis B Infection: Hepatitis B surface antigen (HBsAg) and anti-hepatitis B core antibody (anti-HBc) tests must be performed before medication use. Patients with positive results require consultation with specialists.

Abnormal Liver Function: Not recommended for patients with cirrhosis, especially those with Child-Pugh Class C cirrhosis.

Pre-Medication Assessment

Liver Function Testing: Tests for alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, and total bilirubin are required.

Infection Status Assessment: Medication use should be postponed in patients with active infections (including local infections).

Vaccination: Live vaccines must be administered 4 weeks before starting the medication.

Administration Standards

Standard Dosage: 30 mg (3 × 10 mg capsules) twice daily, taken with food.

Capsule Administration: Capsules must be swallowed whole; do not crush, chew, or open them.

Missed Dose Management: Skip the missed dose and take the next regular dose as scheduled.

Patients with Abnormal Liver Function

No dosage adjustment is needed for patients with mild or moderate liver impairment (Child-Pugh Class A/B).

There is insufficient research data for patients with severe liver impairment (Child-Pugh Class C), so careful evaluation is required.

Patients with Renal Impairment

No dosage adjustment is needed for patients with mild, moderate, or severe renal impairment.

There is no experience data on the use of this medication in dialysis patients.

Pregnancy and Lactation

Pregnancy: Animal studies suggest it may increase the risk of miscarriage, and human data are limited.

Lactation: The drug can be excreted into animal milk; it is recommended to weigh the pros and cons before deciding whether to breastfeed.

Avacopan (Tavneos) Medication Monitoring

Liver Function Monitoring

Baseline Testing: A full set of liver function tests must be completed before starting the medication.

Regular Monitoring: Test once every 4 weeks for the first 6 months after treatment initiation, and then as clinically needed thereafter.

Abnormality Management: If ALT/AST > 3 × upper limit of normal (ULN): Suspend medication use and conduct an evaluation.

If ALT/AST > 5 × ULN or accompanied by bilirubin > 2 × ULN: Discontinue the medication immediately.

Infection Monitoring

Common Infections: Pneumonia (4.8%), urinary tract infections (1.8%), herpes virus infections (2.1-5%).

Special Infections: Hepatitis B virus (HBV) reactivation: Monitor for hepatitis symptoms and laboratory indicators.

Opportunistic Infections: Conduct a comprehensive evaluation immediately if a new infection occurs.

Management Principle: Suspend medication administration during severe infections, and resume use after the infection is controlled.

Adverse Reaction Monitoring

Common Reactions: Nausea (23.5%), headache (20.5%), hypertension (18.1%), diarrhea (15.1%).

Severe Reactions: Angioedema (1.2%): Discontinue the medication immediately and provide emergency treatment.

Elevated Creatine Kinase (3.6%): Evaluate for muscle symptoms.