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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AEs/Incidence of Infection

Most common adverse reactions reported in ≥5% of patients and higher in the TAVNEOS® arm vs the Standard Therapy arm in a phase 3 trial1

Adverse reaction TAVNEOS® (N = 166), n (%) Standard Therapy (N = 164), n (%)
Nausea 39 (23.5) 34 (20.7)
Headache 34 (20.5) 23 (14.0)
Hypertension 30 (18.1) 29 (17.7)
Diarrhea 25 (15.1) 24 (14.6)
Vomiting 25 (15.1) 21 (12.8)
Rash 19 (11.4) 13 (7.9)
Fatigue 17 (10.2) 15 (9.1)
Upper abdominal pain 11 (6.6) 10 (6.1)
Dizziness 11 (6.6) 10 (6.1)
Blood creatinine increased 10 (6.0) 8 (4.9)
Paresthesia 9 (5.4) 7 (4.3)

Incidence of infection, including serious infections, in the TAVNEOS® arm vs Standard Therapy arm2

Safety results TAVNEOS® (N = 166) Standard Therapy (N = 164)
Any infection
No. of patients (%) 113 (68.1) 124 (75.6)
No. of events 233 291
Any serious infection
No. of patients (%) 22 (13.3) 25 (15.2)
No. of events 25 31
Any serious opportunistic infection—no. (%) 6 (3.6) 11 (6.7)
Death due to infection—no. (%) 1 (0.6) 2 (1.2)
Life-threatening infection—no. (%) 1 (0.6) 2 (1.2)
AE = adverse event; No. = Number; no. = number.

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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.
Patients you may meet

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...