Indication: TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody...

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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.

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What are Severe Active GPA and MPA?

GPA and MPA are part of a rare group of small- to medium-vessel vasculitides called ANCA-associated vasculitis, or AAV2-4

An AAV diagnosis can be made in part through the clinical assessment of impaired function in one or multiple organs.5,6
GPA and MPA are a part of a rare group of vasculitides called AAV
  • Severe vasculitis is defined by the American College of Rheumatology/Vasculitis Foundation (ACR/VF) guidelines as having life-threatening or organ-threatening manifestations. This is inclusive of multi-organ and localized symptoms7
    • Approximately 80% to 90% of patients with AAV present with renal or other organ-threatening disease activity8
  • ACR/VF guidelines define “active” as new, persistent, or worsening signs and/or symptoms attributed to GPA or MPA, and not related to prior damage7

Severe active GPA and MPA are characterized by neutrophil-induced inflammation and scarring of small- to medium-vessel endothelia9

Severe active GPA and MPA characterized by neutrophil-induced inflammation and scarring of small-to-medium vessel endothelia
Severe active GPA and MPA characterized by neutrophil-induced inflammation and scarring of small-to-medium vessel endothelia
anca
ANCA
c5a
C5a
c5a4
C5aR
cytokine-receptor
Cytokine receptor
MPO-PR3-antigen
MPO/PR3 antigen
  • The initial injury to vessel walls may result in:9
    • hemorrhage and
    • release of plasma proteins (including coagulation factors) into the vessel walls and adjacent extravascular tissue
  • Activated coagulation factors produce fibrin that forms at sites of injury which, in time, leads to necrosis9
  • Severe injury to a vessel could manifest in one or more organ systems7,10,11
C5a = complement fragment 5a; C5aR = C5a receptor; MPO = myeloperoxidase; PR3 = proteinase 3.

Progressive inflammation and vascular injury by neutrophils is perpetuated through a vicious feedback loop that is fueled in part by a complement-mediated pathway12

Common Terms

Common terms associated with GPA and MPA
ANCA-associated vasculitis (AAV) A rare group of necrotizing vasculitides that predominantly affects small-to-medium blood vessels9,13
Granulomatosis with polyangiitis (GPA) A subtype of AAV, previously called “Wegener’s granulomatosis,” that features necrotizing granulomatous inflammation and is commonly associated with PR3-ANCA9,13
Microscopic polyangiitis (MPA) Another subtype of AAV where granulomatous inflammation is absent and is commonly associated with MPO-ANCA9,13
Pauci-immune crescentic glomerulonephritis (PICGN) A form of rapidly progressing glomerulonephritis (RPGN) is one of the common manifestations of GPA and MPA that can lead to renal failure14
ACR = American College of Rheumatology; ANCA = anti-neutrophil cytoplasmic antibody; GPA = granulomatosis with polyangiitis; MPA = microscopic polyangiitis; MPO-ANCA = myeloperoxidase anti-neutrophil cytoplasmic antibody; PR3-ANCA = proteinase 3 anti-neutrophil cytoplasmic antibody.

See why disease burden may remain high for adult patients with severe active GPA or MPA

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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.

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.

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. Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Neque porro quisquam est, qui dolorem ipsum quia dolor.
References: 1. TAVNEOS [package insert]. Cincinnati, OH: Amgen Inc. 2. Data on file, Amgen. Clinical Study Report [92070]; 2020. 3. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. N Engl J Med. 2021;384(7):599-609. 4. Data on file, Amgen. Study Supplied [91955]; 2021. 5. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383. 6. Mukhtyar C, Lee R, Brown D, et al. Ann Rheum Dis. 2009;68(12):1827-1832.
References: 1. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383. 2. Neumann I. Rheumatology (Oxford). 2020;59(Suppl 3):iii60-iii67. 3. Data on file, Amgen. Clinical Study Report [92070];2020. 4. King C, Druce KL, Nightingale P, et al. Rheumatol Adv Pract. 2021;5(3):rkab018. 5. Jain K, Jawa P, Derebail VK, et al. Kidney360. 2021;2(4):763-770. 6. Kitching AR, Anders H-J, Basu N, et al. Nat Rev Dis Primers. 2020;6(1):71. 7. Yates M, Watts R. Clin Med (Lond). 2017;17(1):60-64. 8. Robson J, Doll H, Suppiah R, et al. Rheumatology (Oxford). 2015;54(3):471-481. 9. Geetha D, Jefferson JA. Am J Kidney Dis. 2020;75(1):124-137. 10. Supplement to: Walsh M, Merkel PA, Peh C-A, et al; PEXIVAS Investigators. N Engl J Med. 2020;382(7):622-631. 11. Terrier B, Pagnoux C, Perrodeau E, et al. Ann Rheum Dis. 2018;77(8):1151-1157. 12. Guillevin L, Pagnoux C, Karras A, et al. N Engl J Med. 2014;371(19):1771-1780. 13. Data on file, Amgen. Harris Poll [91973]; 2022. 14. Robson JC, Dawson J, Cronholm PF, et al. Patient Relat Outcome Meas. 2018;9:17-34. 15. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. N Engl J Med. 2021;384(7):599-609.
References: 1. TAVNEOS [package insert]. Cincinnati, OH: Amgen Inc. 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. N Engl J Med. 2021;384(7):599-609. 3. Data on file, Amgen. Clinical Study Report [92070]; 2020. 4. Supplement to: Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. N Engl J Med. 2021;384(7):599-609. 5. Data on file, Amgen. [92252]; 2020. 6. Kaplan-Pavlovčič S, Cerk K, Kveder R, et al. Nephrol Dial Transplant. 2003;18(suppl5):v5-v7. 7. Stangou M, Asimaki A, Bamichas G, et al. J Nephrol. 2005;18(1):35-44. 8. Data on file, Amgen. [92757]; 2020. 9. Preedy VR, Watson RR, eds. Handbook of Disease Burdens and Quality of Life Measures. Springer Science+Business Media; 2010. 10. Data on file, Amgen. [91955]; 2021.
References: 1. TAVNEOS [package insert]. Cincinnati, OH: Amgen Inc. 2. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. N Engl J Med. 2021;384(7):599-609.
References: 1. TAVNEOS [package insert]. Cincinnati, OH: Amgen Inc. 2. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383.
References: 1. TAVNEOS [package insert]. Cincinnati, OH: Amgen Inc. 2. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383.
References: 1. TAVNEOS [package insert]. Cincinnati, OH: Amgen Inc. 2. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383.
References: 1. TAVNEOS [package insert]. Cincinnati, OH: Amgen Inc. 2. Data on file, Amgen. Clinical Study Report [92070]; 2020. 3. Khan MM, Molony DA. Ann Intern Med. 2021;174(7):JC79. 4. Chen M, Jayne DRW, Zhao M-H. Nat Rev Nephrol. 2017;13(6):359-367. 5. Samman KN, Ross C, Pagnoux C, et al. Int J Rheumatol. 2021;2021:5534851. 6. Kitching AR, Anders H-J, Basu N, et al. Nat Rev Dis Primers. 2020;6(1):71. 7. Al-Hussain T, Hussein MH, Conca W, et al. Adv Anat Pathol. 2017;24(4):226-234. 8. Jennette JC, Nachman PH. Clin J Am Soc Nephrol. 2017;12(10):1680-1691. 9. Shochet L, Holdsworth S, Kitching AR. Front Immunol. 2020;11:525.
References: 1. Smith RM, Jones RB, Jayne DRW. Arthritis Res Ther. 2012;14(2):210. 2. Berti A, Dejaco C. Best Pract Res Clin Rheumatol. 2018;32(2):271-294. 3. Berden A, Göçeroğlu A, Jayne D, et al. BMJ. 2012;344:e26. 4. Jennette JC, Falk RJ, Bacon PA, et al. Arthritis Rheum. 2013;65(1):1-11. 5. Mukhtyar CB. General presentation of the vasculitides. In: Watts RA, Scott DGI, eds. Vasculitis in Clinical Practice. Springer; 2010:13-19. 6. Terrier B, Darbon R, Durel C-A, et al. Orphanet J Rare Dis. 2020;15(suppl2):351. 7. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383. 8. Lamprecht P, Kerstein A, Klapa S, et al. Front Immunol. 2018;9:680. 9. Al-Hussain T, Hussein MH, Conca W, et al. Adv Anat Pathol. 2017;24(4):226-234. 10. Qasim A, et al. In: StatPearls [Internet]. StatPearls Publishing; 2023. Accessed March 31, 2023. https://www.ncbi.nlm.nih.gov/books/NBK554372/ 11. Hunter RW, Welsh N, Farrah TE, et al. BMJ. 2020;369:m1070. 12. Chen M, Jayne DRW, Zhao M-H. Nat Rev Nephrol. 2017;13(6):359-367. 13. Yates M, Watts R. Clin Med (Lond).2017;17(1):60-64. 14. Syed R, Rehman A, Valecha G, et al. Biomed Res Int. 2015;2015:402826.
References: 1. Lamprecht P, Kerstein A, Klapa S, et al. Front Immunol. 2018;9:680. 2. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383. 3. Data on file, Amgen. Clinical Study Report [92070];2020. 4. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. N Engl J Med. 2021;384(7):599-609. 5. Supplement to: Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. N Engl J Med. 2021;384(7):599-609. 6. Mukhtyar CB. General presentation of the vasculitides. In: Watts RA, Scott DGI, eds. Vasculitis in Clinical Practice. Springer; 2010:13-19. 7. Geetha D, Jefferson JA. Am J Kidney Dis. 2020;75(1):124-137. 8. Salama AD. Kidney Int Rep. 2020;5(1):7-12. 9. Hellmich B, Sanchez-Alamo B, Schirmer JH, et al. Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-223764 10. Kitching AR, Anders H-J, Basu N, et al. Nat Rev Dis Primers. 2020;6(1):71. 11. Jariwala MP, Laxer RM. Front Pediatr. 2018;6:226. 12. Macarie SS, Kadar A. Rom J Ophthalmol. 2020;64(1):3-7. 13. Palmucci S, Inì C, Cosentino S, et al. Diagnostics (Basel). 2021;11(12):2318. 14. Lionaki S, Skalioti C, Marinaki S, et al. Pauci-immune vasculitides with kidney involvement. In: Mohammed RHA, ed. Vasculitis in Practice: An Update on Special Situations – Clinical and Therapeutic Considerations. InTechOpen; 2018. 15. Yang J, Li M. BMJ. 2022;376:e065658. 16. Kermani TA, Cuthbertson D, Carette S, et al; Vasculitis Clinical Research Consortium. J Rheumatol. 2016;43(6):1078-1084. 17. Merkel PA, Aydin SZ, Boers M, et al. J Rheumatol. 2011;38(7):1480-1486. 18. Mukhtyar C, Lee R, Brown D, et al. Ann Rheum Dis. 2009;68(12):1827-1832. 19. Pagnoux C. Eur J Rheumatol. 2016;3(3):122-133. 20. Data on file, Amgen. LabCorp Sample [93232]; 2022. 21. Zagelbaum N, Shamim Z, Gilani A, et al. Pulm Crit Care Med. 2016;1(3):1-4.
References: 1. Data on file, Amgen. TAVNEOS Payer Approval Percentage [93621]; 2023. 2. Data on file, Amgen. TAVNEOS Time to First Drug Shipment [93622]; 2023. 3. Data on file, Amgen. Patient and Prescriber Counts [93239]; 2023.
References: 1. Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Neque porro quisquam est, qui dolorem ipsum quia dolor.
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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...