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 block button image
Prescribing Information Medication Guide

TREATMENT PERSPECTIVES®

ANCA-associated vasculitis (GPA and MPA) is a group of chronic autoimmune diseases that affect vasculature throughout the body1-3

Test your knowledge of severe active GPA and MPA

Boxes image

QUESTION:

Which of the following is true of patients with ANCA-associated vasculitis (GPA or MPA)?4-7

YOUR ANSWER:

CORRECT ANSWER IS: D
GPA MPA AAV Graphic

GPA and MPA are part of a rare group of small- to medium-vessel vasculitides called ANCA-associated vasculitis, or AAV.8-10

  • An AAV diagnosis can be made in part through the clinical assessment of impaired function in one or multiple organs11,12

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 symptoms.13

  • Approximately 80% to 90% of patients with AAV present with renal or other organ-threatening disease activity4

ACR/VF guidelines define “active” as new, persistent, or worsening clinical signs and/or symptoms attributed to GPA or MPA, and not related to prior damage.13

For adult patients living with severe active ANCA-associated vasculitis (GPA or MPA), disease burden remains high.

Even with standard therapy, some patients may continue to experience symptoms13,14

Despite advancements in therapy, patients grappling with these chronic conditions still suffer from a long journey to diagnosis, a high risk of relapse, treatment-related toxicities, and a diminished quality of life.2,3,15-17

Treatment regimens icon
  • Treatment regimens can carry risk for toxicity5-7
    • Commonly used treatment options such as glucocorticoids can still pose serious risks, even at reduced doses14,18
Sustained remission icon
  • The attainment of sustained remission remains an elusive goal for many patients2
    • In a recent clinical trial, the 5-year relapse rate for patients who received rituximab as maintenance therapy for 18 months* was 35% (23% for major† relapses and 12% minor relapses‡)14,18

Patients in the clinical trial were treated with combined glucocorticoids and ‘pulse’ IV cyclophosphamide to achieve complete remission before being randomized to receive either azathioprine for 22 months or rituximab for 18 months as maintenance treatment. In this trial, prednisone was started and tapered gradually and maintained at a low dose (5 mg) for at least 18 months after randomization.18

Major relapse: reappearance or worsening of disease with BVAS >0 and involvement of at least one major organ, a life-threatening manifestation, or both.18

Minor relapse: reappearance or worsening of disease with BVAS >0, not corresponding to a major relapse but requiring mild treatment intensification.18

LEARN MORE ABOUT TAVNEOS® (avacopan) AS AN ADJUNCTIVE TREATMENT OPTION FOR YOUR APPROPRIATE PATIENTS WITH SEVERE ACTIVE GPA OR MPA

ANCA = anti-neutrophil cytoplasmic autoantibody; GPA = granulomatosis with polyangiitis; MPA = microscopic polyangiitis.

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 co-administration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS. Co-administration of avacopan and 40 mg simvastatin increases the systemic exposure ofsimvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS.

TAVNEOS is available as a 10 mg capsule.

Please click here for 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. Smith RM, Jones RB, Jayne DRW. Arthritis Res Ther. 2012;14(2):210. 2. King C, Druce KL, Nightingale P, et al. Rheumatol Adv Pract. 2021;5(3):rkab018. 3. Kitching AR, Anders H-J, Basu N, et al. Nat Rev Dis Primers. 2020;6(1):71. 4. Lamprecht P, Kerstein A, Klapa S, et al. Front Immunol. 2018;9:680. 5. Robson J, Doll H, Suppiah R, et al. Rheumatology (Oxford). 2015;54(3):471-481. 6. Geetha D, Jefferson JA. Am J Kidney Dis. 2020;75(1):124-137. 7. Supplement to: Walsh M, Merkel PA, Peh C-A, et al; PEXIVAS Investigators. N Engl J Med. 2020;382(7):622-631. 8. Berti A, Dejaco C. Best Pract Res Clin Rheumatol. 2018;32(2):271-294. 9. Berden A, Göçeroğlu A, Jayne D, et al. BMJ. 2012;344:e26. 10. Jennette JC, Falk RJ, Bacon PA, et al. Arthritis Rheum. 2013;65(1):1-11. 11. Mukhtyar CB. General presentation of the vasculitides. In: Watts RA, Scott DGI, eds. Vasculitis in Clinical Practice. Springer; 2010:13-19. 12. Terrier B, Darbon R, Durel C-A, et al. Orphanet J Rare Dis. 2020;15(suppl2):351. 13. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383. 14. Neumann I. Rheumatology (Oxford). 2020;59(Suppl 3):iii60-iii67. 15. Data on file, Amgen. Clinical Study Report [92070];2020. 16. Jain K, Jawa P, Derebail VK, et al. Kidney360. 2021;2(4):763-770. 17. Yates M, Watts R. Clin Med (Lond). 2017;17(1):60-64. 18. Guillevin L, Pagnoux C, Karras A, et al. N Engl J Med. 2014;371(19):1771-1780. 19. Terrier B, Pagnoux C, Perrodeau E, et al. Ann Rheum Dis. 2018;77(8):1151-1157.

Exit Interstitial Close Button image

You are leaving the Treatment Perspectives® portal.

Some of the links available on our web pages will allow you to leave this site. You will be taken to another site that may have a privacy policy that is different from ours.

Do you want to continue?