TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with
severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis
with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy
including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
Important Safety Information
Serious hypersensitivity to avacopan or to any of the excipients.
WARNINGS AND PRECAUTIONS
Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including
life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after
start of therapy for 6 months and as clinically indicated thereafter. Monitor patients closely for
hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated
(refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with
active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B,
untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and
benefits before administering this drug to a patient with liver disease.
Hypersensitivity Reactions:Cases of angioedema occurred in a clinical trial, including 1
serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage
accordingly. TAVNEOS must not be readministered unless another cause has been established.
Hepatitis B Virus
(HBV) Reactivation:Hepatitis B reactivation, including life-threatening hepatitis B, was
observed in the clinical program. Screen patients for HBV. For patients with evidence of prior
infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for
6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and
concomitant therapies associated with HBV reactivation, and consult with experts before resuming.
infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most
common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections.
Avoid use of TAVNEOS in patients with active, serious infection, including localized infections.
Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at
increased risk of infection, or who have been to places where certain infections are common.
The most common adverse reactions (≥5% of patients and higher in the
TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash,
fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.
Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme
inducers. Reduce TAVNEOS dose when coadministered with strong CYP3A4 enzyme inhibitors to 30 mg
once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4
TAVNEOS is available as a 10 mg capsule.
Please see Full Prescribing
Information and Medication Guide for
To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA
directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.