The safety of TAVNEOS was assessed over 52 weeks1

Adverse reactions reported in ≥5% of patients and higher in TAVNEOS group vs prednisone group in phase 3 trial1

Chart listing  adverse reactions

N=number of patients randomized to treatment group in the safety population;
n=number of patients in specified category.

A blue bird flying out from a cage made of inflamed vasculature

Serious adverse reactions in patients treated with TAVNEOS or prednisone

The most common serious adverse reactions reported more frequently in patients treated with TAVNEOS than with prednisone were1,2*:
  • Pneumonia: 4.8% (n=8) TAVNEOS vs 3.7% (n=6) prednisone1,2
  • GPA: 3.0% (n=5) TAVNEOS vs 0.6% (n=1) prednisone1,2
  • Acute kidney injury: 1.8% (n=3) TAVNEOS vs 0.6% (n=1) prednisone1,2
  • Urinary tract infection: 1.8% (n=3) TAVNEOS vs 1.2% (n=2) prednisone1,2
  • In the phase 3 trial, within 52 weeks, 2 patients (1.2%) treated with TAVNEOS and 4 patients (2.4%) treated with prednisone died; there were no deaths in the phase 2 trials1

  • 7 patients (4.2%) treated with TAVNEOS and 2 patients (1.2%) treated with prednisone discontinued treatment due to hepatic-related adverse reactions including hepatobiliary adverse reactions and liver enzymes abnormalities1

    • The most frequent adverse reaction that led to drug discontinuation reported by >1 patient and more frequently reported in patients treated with TAVNEOS was hepatic function abnormal (1.8%)1

  • Serious adverse events were defined as any adverse event that resulted in death, was immediately life-threatening, required or prolonged hospitalization, resulted in persistent or clinically significant disability or incapacity, was a birth defect, or was an important event that might jeopardize the patient or might have required intervention to prevent any of the above.3

TAVNEOS is an orally administered adjunctive treatment for adults with severe active ANCA-associated vasculitis (GPA and MPA)1

Typical schedule: take 3 TAVNEOS capsules with breakfast and 3 TAVNEOS capsules with dinner.1

6 capsules daily
sun
Morning
sun-pills
With food
moon
Evening
moon-pills
With food
  • The recommended dose of TAVNEOS is 30 mg (three 10 mg capsules) twice daily, with food1
  • Advise patients that TAVNEOS capsules should not be crushed, chewed, or opened1
  • If a dose is missed, instruct the patient to wait until the usual scheduled time to take the next regular dose. Instruct the patient not to double the next dose1
  • Administer TAVNEOS 30 mg once daily when coadministered with strong CYP3A4 inhibitors1

INDICATION

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

CONTRAINDICATIONs

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: 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.

Serious 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.

Serious Infections: Serious 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.

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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 substrates.

TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

INDICATION

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.

INDICATION

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.

INDICATION

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

CONTRAINDICATIONs

Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: 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.

Serious 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.

Serious Infections: Serious 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.

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

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 substrates.

TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

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.

References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. Data on File, ChemoCentryx, Inc. 3. Jayne DRW, Merkel PA, Schall TJ, Bekker P, for the ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386