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TAVNEOS is an oral, selective inhibitor of the C5a receptor1,2

Activation of the alternative complement system plays a crucial role in the pathogenesis of ANCA‑associated vasculitis.3

Chart showing TAVNEOS and the role of C5a
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Complement System
A central mediator of immunothrombosis and vascular necroinflammation in anti‑neutrophil cytoplasmic autoantibody (ANCA)‑associated vasculitis. There are 3 pathways of the complement system: classical, lectin, and alternative.4,5
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Alternative Pathway
Believed to be crucial in the pathogenesis of ANCA‑associated vasculitis.3
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Complement Peptides
In particular, C5 activation leads to the formation of complement peptides C5a and C5b. C5b fuels the formation of the membrane attack complex (MAC) that is essential for host defense, whereas C5a acts as a potent chemoattractant that recruits immune cells to the site of tissue injury. In ANCA‑associated vasculitis, C5a binds to C5a receptors (C5aR) on neutrophils, causing the release of destructive mediators that chronically inflame and eventually damage vascular tissues and the organs fed by those blood vessels.3-6
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TAVNEOS
TAVNEOS is an antagonist of C5aR. TAVNEOS blocks C5a-mediated neutrophil activation and migration, and is not believed to impact the formation of the MAC. However, the precise mechanism by which TAVNEOS exerts its effect in patients with ANCA‑associated vasculitis has not been definitively established.1,4
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Priming
Neutrophils are primed (partially activated) by a combination of factors, including the inflammatory milieu of cytokines produced in response to an infection or another event.3
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Neutrophil Activation and NETosis
ANCA binds to target antigens on the cell surface of neutrophils. This causes them to activate and ultimately produce additional C5a. ANCA‑induced neutrophil activation also results in NETosis (an explosion‑like form of neutrophil death during which neutrophils expel their chromatin and granular content into the extracellular space).4-6
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Microvascular Necroinflammation Loop
Occurs between neutrophils and the complement system. The ANCA‑induced activation of neutrophils generates C5a, which, in turn, increases neutrophil recruitment and priming, and intensifies the inflammatory response. This can lead to tissue damage and other clinical manifestations of ANCA‑associated vasculitis.3-5,7
ADVOCATE Trial

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. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599 609. doi:10.1056/NEJMoa2023386 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7)(suppl):1 41. 3. Warrington KJ. Avacopan - time to replace glucocorticoids? N Engl J Med. 2021;384(7):664 665. doi:10.1056/NEJMe2033621 4. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 5. Data on File, ChemoCentryx, Inc.
References: 1. King C, Harper L, Little M. The complications of vasculitis and its treatment. Best Pract Res Clin Rheumatol. 2018;32(1):125-136. doi:10.1016/j.berh.2018.07.009 2. Jennette JC, Nachman PH. ANCA glomerulonephritis and vasculitis. Clin J Am Soc Nephrol. 2017;12(10):1680-1691. doi:10.2215/CJN.02500317 3. Guillevin L, Pagnoux C, Karras A, et al. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014;371(19):1771-1780. doi:10.1056/NEJMoa1404231 4. Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363(3):221-232. doi:10.1056/NEJMoa0909905 5. Specks U, Merkel PA, Seo P, et al. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013;369(5):417-427. doi:10.1056/NEJMoa1213277 6. Yasir M, Goyal A, Bansal P, et al. Corticosteroid adverse effects. StatPearls [Internet]. Accessed May 5, 2021. https://www.ncbi.nlm.nih.gov/books/NBK531462 7. Little MA, Nightingale P, Verburgh CA, et al. Early mortality in systemic vasculitis: relative contribution of adverse events and active vasculitis. Ann Rheum Dis. 2010;69(6):1036-1043. doi:10.1136/ard.2009.109389
References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the treatment of ANCA-associated vasculitis. N Engl J Med. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386 3. Al-Hussain T, Hussein MH, Conca W, Al Mana H, Akhtar M. Pathophysiology of ANCA-associated vasculitis. Adv Anat Pathol. 2017;24(4):226-234. doi:10.1097/PAP.0000000000000154 4. Anders HJ, Nakazawa D. Being an ADVOCATE for people with ANCA vasculitis. Clin J Am Soc Nephrol. 2021;16(10):1581-1583. doi:10.2215/CJN.03670321 5. Chen M, Jayne DRW, Zhao MH. Complement in ANCA-associated vasculitis: mechanisms and implications for management. Nat Rev Nephrol. 2017;13(6):359-367. doi:10.1038/nrneph.2017.37 6. Jennette JC, Nachman PH. ANCA glomerulonephritis and vasculitis. Clin J Am Soc Nephrol. 2017;12(10):1680-1691. doi:10.2215/CJN.02500317 7. Moiseev S, Lee JM, Zykova A, et al. The alternative complement pathway in ANCA-associated vasculitis: further evidence and a meta-analysis. Clin Exp Immunol. 2020;202(3):394-402. doi:10.1111/cei.13498
References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. 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 3. Data on File, ChemoCentryx, Inc.
References: 1. TAVNEOS® (avacopan) Prescribing Information. ChemoCentryx, Inc. 2. 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 3. Data on File, ChemoCentryx, Inc. 4. Miloslavsky EM, Naden RP, Bijlsma JW, et al. Development of a glucocorticoid toxicity index (GTI) using multicriteria decision analysis. Ann Rheum Dis. 2017;76(3):543-546. doi:10.1136/annrheumdis-2016-210002 5. McDowell PJ, Stone JH, Zhang Y, et al. Quantification of glucocorticoid-associated morbidity in severe asthma using the glucocorticoid toxicity index. J Allergy Clin Immunol Pract. 2021;9(1):365-372.e5. doi:10.1016/j.jaip.2020.08.032
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

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.