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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Severe Active Disease
  • Severe vasculitis is defined by American College of Rheumatology/Vasculitis Foundation (ACR/VF) guidelines as having life-threatening or organ-threatening manifestations2
  • Active vasculitis is defined by ACR/VF guidelines as new, persistent or worsening signs and/or symptoms attributed to GPA or MPA and not related to prior damage2
Identifying Patients

Approximately 80%-90% of patients with AAV present with renal or other organ-threatening disease activity, which can be considered severe active disease1,2

Patients in the ADVOCATE trial presented with a spectrum of clinical manifestations.3,4

General

Myalgia, arthralgia, fever, weight loss5,6

ADVOCATE: 68.2% general involvement3

Learn more about the ADVOCATE trial by clicking here.

Please note these are just some of the signs and symptoms of GPA and MPA, which can present differently in each patient.

Careful monitoring may help detect obscure signs that your patients are experiencing severe active disease7-10

Declining graph for disease worsening
DISEASE WORSENING
New or re-emerging manifestations as well as deteriorating lab values (such as subtle elevations in creatinine or emergence of microscopic hematuria) may signal the need for clinical attention8,10,11
Immunosuppressant use
IMMUNOSUPPRESSANT USE
Strong or prolonged immunosuppression treatment could require close monitoring of disease activity7
Localized symptoms
LOCALIZED SYMPTOMS
Localized symptoms do not necessarily preclude the possibility that the disease activity is organ-threatening and may still require close monitoring8-10
Disease activity during maintenance period
DISEASE ACTIVITY DURING
THE “MAINTENANCE” PERIOD
Subtle trends such as persistent or mild hematuria, subtle elevations in creatinine, or ENT symptoms may require a closer look in order to determine disease activity8,10

Successful identification and treatment of severe active GPA and MPA can be challenging and require a careful assessment of heterogenous symptoms10

ANCA-associated vasculitis with scleritis
AAV with scleritis12
Image used with permission from Macarie SS, Kadar A. Rom J Ophthalmol.
Chest computer tomography (CT) with ground-glass opacities
Chest computer tomography (CT) with ground-glass opacities in a patient with AAV with acute pulmonary hemorrhage13
Image used with permission from Palmucci S, Inì. C, Cosentino S, et al. Diagnostics (Basel).
Chest computer tomography (CT) with bilateral nodules and masses
Chest CT with bilateral nodules and masses13
Image used with permission from Palmucci S, Inì. C, Cosentino S, et al. Diagnostics (Basel).
Sinonasal disease with coronal CT showing damage in nasal cavity
Sinonasal disease with coronal CT images showing destruction of the nasal cavity10
Image used with permission from Kitching AR, Anders H-J, Basu N, et al. Nat Rev Dis Primers.
Kidney biopsy showing necrotizing pauci-immune glomerulonephritis
Kidney biopsy demonstrating necrotizing, pauci-immune glomerulonephritis14
Image used with permission from Vasculitis in Practice, Mohammed RHA (ed), InTechOpen, 2018.
Bilateral lower extremity purpura
Bilateral lower extremity purpura15
Reproduced from Purpuric lesions in a patient with ANCA-associated vasculitis, BMJ, Yang et al., 376,e065658, copyright notice 2023 with permission from BMJ Publishing Group Ltd.
AAV = ANCA-associated vasculitis; ENT = ear, nose, and throat; GPA = granulomatosis with polyangiitis; MPA = microscopic polyangiitis.
BVAS Overview

The Birmingham Vasculitis Activity Score (BVAS) is a clinical tool used to quantify systemic vasculitis disease activity primarily in clinical trials such as ADVOCATE16,17

There are 56 clinical features, grouped into 9 organ systems plus an “Other” category, each of which is given a numerical value according to its perceived clinical relevance as decided by expert consensus.3,16,18 Additionally, the BVAS:

  • Was developed by consensus expert opinion
  • Has been in use for over 25 years
  • Is considered the most effective validated tool to measure systemic vasculitic disease activity

The BVAS evaluates clinical items in the following organ systems:16,18

Renal

Renal

Nervous system

Nervous system

Chest/pulmonary

Chest

abdominal

Abdominal

cardiovascular

Cardiovascular

cutaneous

Cutaneous

Mucous membranes and eyes

Mucous membranes and eyes

Ear, nose, throat

Ear/nose/throat

The 9th clinical item is “general” which includes myalgia, arthralgia/arthritis, fever, weight loss.16

A higher total BVAS equates to a more active vasculitic disease at the time of evaluation.16,18
The BVAS is a validated outcome measure with demonstrated high reliability. It is efficient in terms of time and effort and is recommended for use in clinical trials.17,18
BVAS Overview

While the BVAS is primarily used in clinical trials, it may be helpful to understand the spectrum of manifestations that could indicate severe active GPA and MPA16,18

The below information is adapted from the BVAS Version 3.0. Below are the manifestations listed in the BVAS organized by organ system.6

Abdominal

  • Peritonitis
  • Bloody diarrhea
  • Ischemic abdominal pain

Cutaneous

  • Infarct
  • Purpura
  • Ulcer
  • Gangrene
  • Other skin vasculitis

Nervous system

  • Headache
  • Meningitis
  • Organic confusion
  • Seizures (not hypertensive)
  • Cerebrovascular accident
  • Spinal cord lesion
  • Cranial nerve palsy
  • Sensory peripheral neuropathy
  • Mononeuritis multiplex

Cardiovascular

  • Loss of pulses
  • Valvular heart disease
  • Pericarditis
  • Ischemic cardiac pain
  • Cardiomyopathy
  • Congestive cardiac failure

ENT

  • Bloody nasal discharge/crusts/
    ulcers/granulomata
  • Paranasal sinus involvement
  • Subglottic stenosis
  • Conductive hearing loss
  • Sensorineural hearing loss

Renal

  • Hypertension
  • Proteinuria >1+
  • Hematuria ≥10 RBCs/HPF
  • Serum creatinine 125-249 μmol/L*
  • Serum creatinine 250-499 μmol/L*
  • Serum creatinine ≥500 μmol/L*
  • Rise in serum creatinine >30% or fall in creatinine clearance >25%

Chest

  • Wheeze
  • Nodules or cavities
  • Pleural effusion/pleurisy
  • Infiltrate
  • Endobronchial involvement
  • Massive hemoptysis/alveolar
    hemorrhage
  • Respiratory failure

Mucous membranes/Eyes

  • Mouth ulcers
  • Genital ulcers
  • Adnexal inflammation
  • Significant proptosis
  • Scleritis/Episcleritis
  • Conjunctivitis/Keratitis
  • Blurred vision
  • Sudden visual loss
  • Uveitis
  • Retinal changes (vasculitis/
    thrombosis/exudate/hemorrhage)

General

  • Myalgia
  • Arthralgia/arthritis
  • Fever ≥100.4° F
  • Weight loss ≥2 kg
*

Can only be scored on the first assessment.

BVAS = Birmingham Vasculitis Activity Score; GPA = granulomatosis with polyangiitis; HPF = high-power field; MPA = microscopic polyangiitis; RBC = red blood count.

Testing Considerations

Testing and diagnostic considerations in severe active GPA and MPA

ANCA serology

  • c-ANCA/PR3 antibodies are most frequently seen in GPA, and p-ANCA/MPO antibodies are most often associated with MPA7,19
  • Although these antibodies are most frequently associated with respective diagnoses, ANCA positivity and specific antibodies vary by condition19

Frequency of ANCA types7

ANCA-associated
vasculitis		 PR3-ANCA
(mostly c-ANCA)		 MPO-ANCA
(mostly p-ANCA)		 Other
GPA 75% 20% 5% ANCA-negative
MPA 30% 60% 10% ANCA-negative
ANCA-associated
vasculitis		 GPA
PR3-ANCA
(mostly c-ANCA) 		75%
MPO-ANCA
(mostly p-ANCA) 		20%
Other 5% ANCA-negative
ANCA-associated
vasculitis		 MPA
PR3-ANCA
(mostly c-ANCA) 		30%
MPO-ANCA
(mostly p-ANCA) 		60%
Other 10% ANCA-negative
Example lab results for ANCA profile

Example lab results for ANCA profile20

A full ANCA profile can be used in diagnosing
severe active GPA and MPA.

Biopsy10

Biopsy is another supportive tool that can be confirmatory, particularly in cases with renal, pulmonary, or skin involvement, but treatment should not necessarily be delayed simply to get a biopsy.

Pathology results from a real kidney biopsy with AAV
Image used with permission from Zagelbaum N, Zainab S, Gilani A, et al. Pulm Crit Care Med

Pathology results from a kidney biopsy with AAV21

Renal biopsy in a patient with severe active AAV showing

  1. Severe interstitial inflammation (shown by the arrow)
  2. Segmental necrotizing and crescentic
    glomerulonephritis (shown by the arrow)
AAV = ANCA-associated vasculitis; c-ANCA = cytoplasmic-ANCA; GPA = granulomatosis with polyangiitis; MPA = microscopic polyangiitis; MPO-ANCA = myeloperoxidase anti-neutrophil cytoplasmic antibody; p-ANCA = perinuclear ANCA; PR3-ANCA = proteinase (PR)3-ANCA.
ICD-10 Coding

ICD-10 codes can help identify patients with severe active GPA or MPA who may be appropriate for TAVNEOS®

This page provides a few examples of queries on electronic medical records or practice management systems that may be helpful in identifying appropriate patients for TAVNEOS®.

ICD-10 codes associated with GPA or MPA
M31.3 Granulomatosis with Polyangiitis (GPA)*
M31.30 Granulomatosis with Polyangiitis (GPA) without renal involvement
M31.31 Granulomatosis with Polyangiitis (GPA) with renal involvement
M31.7 Microscopic Polyangiitis (MPA)
177.6 Unspecified Arteritis†
177.82 Anti-neutrophil cytoplasmic antibody (ANCA) vasculitis
*

GPA is formerly known as Wegener’s granulomatosis.

†

The diagnosis is related to ANCA-associated vasculitis or GPA/MPA, specifically, and confirmed or awaiting confirmation using one or more lab tests: ANCA serum/biopsy/urinalysis.

ICD-10 codes and EMR can also help identify adult patients who may have undiagnosed severe active GPA or MPA

The following codes represent generalized symptoms that are common manifestations of GPA and MPA:

ICD-10 Code Manifestation
Vasculitic rash with systemic features
L98.9 Dermatosis
R23.3 Purpuric
R50.9 Fever
Respiratory symptoms
R04.2 Hemoptysis
R06.00 Dyspnea
R06.02 Shortness of breath
R05.9 Cough
J45.909 Asthma
J44.9 Chronic
Renal disease
N05.9 Glomerulonephritis
ICD-10 Code Manifestation
Ear, nose, throat/upper airway symptoms
J32.9 Sinusitis
J01.81 Recurrent
H92.0 Earache
H90.2 Conductive hearing loss
M95.0 Saddle nose
J95.5 Subglottic stenosis
Eye symptoms
H15.00 Scleritis
H53.2 Diplopia
Nerve Symptoms
R20.2 Paresthesia
G62.9 Neuropathy, neuropathic
EMR = electronic medical record; ICD-10 = International Classification of Diseases, Tenth Revision.

The information on this page is informational and is not intended to be instructive with respect to clinical decision-making or billing and coding. Healthcare providers are solely responsible for clinical decisions and ensuring the accuracy and validity of all billing and claims. This is not a guarantee of coverage or reimbursement for any product or service.

You’ve seen the efficacy data from the phase 3 trial. Now see how TAVNEOS® can help adult patients in these examples

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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 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 coadministering TAVNEOS. Co-administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. 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.

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. Terrier B, Pagnoux C, Perrodeau E, et al; French Vasculitis Study Group. Ann Rheum Dis. 2018;77(8):1151-1157. 5. Data on file, Amgen; Study Supplied [91955]; 2021. 6. Chung SA, Langford CA, Maz M, et al. Arthritis Rheumatol. 2021;73(8):1366-1383. 7. 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(suppl 5):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; Study Supplied [91955]; 2021. 11. Hellmich B, Sanchez-Alamo B, Schirmer JH, et al. Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-223764
References: 1. Samman KN, Ross C, Pagnoux C, Makhzoum J-P. Int J Rheumatol. 2021;2021:5534851. 2. TAVNEOS [package insert]. Cincinnati, OH: Amgen Inc. 3. 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. Kitching AR, Anders H-J, Basu N, et al. Nat Rev Dis Primers. 2020;6(1):71. 6. Al-Hussain T, Hussein MH, Conca W, Al Mana H, Akhtar M. Adv Anat Pathol. 2017;24(4):226-234. 7. Jennette JC, Nachman PH. Clin J Am Soc Nephrol. 2017;12(10):1680-1691. 8. Shochet L, Holdsworth S, Kitching AR. Front Immunol. 2020;11:525. 9. Jones RB, Ferraro AJ, Chaudhry AN, et al. Arthritis Rheum. 2009;60(7):2156-2168. 10. Winkelstein A. Blood. 1973;41(2):273-284. 11. Eickenberg S, Mickholz E, Jung E, et al. Arthritis Res Ther. 2012;14(3):R110. 12. Ogino MH, Prasanna T. In: StatPearls [Internet]. StatPearls Publishing; 2023. Accessed October 3, 2023. https://www.ncbi.nlm.nih.gov/books/NBK553087/ 13. Mohammadi O, Kassim TA. In: StatPearls [Internet]. StatPearls Publishing; 2023. 14. Anders H-J, Nakazawa D. CJASN. 2021;16:1581-1583.
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.
Patient cases

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...