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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Patient Overview

Get to know patients like yours who could be candidates for TAVNEOS®

As an adjunctive therapy, TAVNEOS® can be initiated with or added to standard therapy for severe active GPA and MPA.1

The following profiles show hypothetical patients and provide some common patient characteristics you may see in patients whom you may consider treating with TAVNEOS®. They are informational only and should not replace your clinical decision-making regarding diagnoses and treatment. Healthcare providers are solely responsible for clinical decisions.

Hypothetical newly diagnosed patient with severe active GPA at the specialty clinic setting

NEWLY DIAGNOSED (Clinic):
Severe Active MPA
62-year-old female

Click here for full profile
Hypothetical newly diagnosed patient with severe active MPA at the hospital emergency department setting

NEWLY DIAGNOSED (Hospital):
Severe Active GPA
71-year-old male

Click here for full profile
Hypothetical patient with persistent disease activity

PERSISTENT DISEASE:
Severe Active GPA
59-year-old male

Click here for full profile
Hypothetical relapsing patient with severe active MPA at the clinic setting

RELAPSING PATIENT:
Severe Active MPA
41-year-old female

Click here for full profile
GPA = granulomatosis with polyangiitis; MPA = microscopic polyangiitis.
Newly Diagnosed, Severe Active MPA
Hypothetical newly diagnosed patient with severe active GPA at the specialty clinic setting

(Hypothetical patient)

Patient with Newly Diagnosed Severe Active MPA: Add TAVNEOS® During Induction

Hypothetical newly diagnosed patient with severe active GPA at the specialty clinic setting

(Hypothetical patient)

Patient characteristics

62-year-old female, school administrator
Enjoys travel with husband and spending time with grandchildren

The following profile shows a hypothetical patient and provides some common patient characteristics you may see in patients who you may consider treating with TAVNEOS®. It is informational only and should not replace your clinical decision-making regarding diagnoses and treatment. Healthcare providers are solely responsible for clinical decisions.

History of present illness

  • Received inconclusive workup 30 days prior by her PCP, based on complaint of fatigue
  • Found to have concomitant hypertension with hyperlipidemia and no other cardiovascular disease
    • Baseline: BP: 145/85 mm Hg (ref: <120 /80 mm Hg)
    • eGFR: 98 mL/min/1.73 m2 (ref: >90 mL/min/1.73 m2)
    • Serum creatinine: 0.8 mg/dL (ref: 0.59 – 1.04 mg/dL)

Current presentation

Presents at the specialty clinic setting with extreme fatigue, hematuria and proteinuria on dipstick, fever, and new-onset lower extremity purpura

Scans

Kidney biopsy indicates necrotizing, pauci-immune glomerulonephritis
Example of kidney biopsy
Image used with permission from Vasculitis in Practice, Mohammed RHA (ed), InTechOpen, 2018.
Bilateral lower extremity purpura
Bilateral lower extremity purpura
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.

Lab values

  • eGFR: 45 mL/min/1.73 m2 (ref: >90 mL/min/1.73 m2)
  • Serum creatinine: 1.2 mg/dL (ref: 0.50–1.10 mg/dL)
  • Urinalysis: hematuria and proteinuria
  • CRP: 15 mg/L (ref: Low risk: <1.0 mg/L; Average risk: 1.0–3.0 mg/L; High risk:
    >3.0 mg/L)
  • ESR: 84 mm/hr (ref: <20 mm/hr)
  • Serology: +p-ANCA, High MPO-ANCA >8.0 AU/mL (ref: 0.0-0.9 AU/mL)

Possible diagnosis

  • Severe active MPA, with renal and cutaneous involvement

Potential treatment decision

  • Induction: Started rituximab; glucocorticoids as needed; started TAVNEOS® 30 mg BID on Day 1
  • Maintenance: Continue on rituximab + TAVNEOS® + glucocorticoids as needed
BID = twice daily; BP = blood pressure; CRP = C-reactive protein; eGFR = estimated glomerular filtration rate; ESR = erythrocyte sedimentation rate; MPA = microscopic polyangiitis; MPO-ANCA = myeloperoxidase-ANCA; p-ANCA = perinuclear-ANCA; PCP = primary care provider.
Newly Diagnosed and Critical, Severe Active GPA
Hypothetical newly diagnosed patient with severe active MPA at the hospital emergency department setting

(Hypothetical patient)

Patient with Newly Diagnosed and Critical, Severe Active GPA:
Start TAVNEOS®

Patient characteristics

71-year-old male, retired banker
Enjoys golfing and attending grandchildren’s sporting events

The following profile shows a hypothetical patient and provides some common patient characteristics you may see in patients who you may consider treating with TAVNEOS®. It is informational only and should not replace your clinical decision-making regarding diagnoses and treatment. Healthcare providers are solely responsible for clinical decisions.

History of present illness

  • Generally in good health but avoids scheduling an annual physical
Hypothetical newly diagnosed patient with severe active MPA at the hospital emergency department setting

(Hypothetical patient)

Current presentation

Presents at the hospital emergency department with severe dyspnea, wheezing, progressive cough; stroke and myocardial infarction ruled out

Scans

Chest CT: Multiple bilateral nodules and masses, extensive at the bases
Example of chest CT scan
Image used with permission from Palmucci S, Inì. C, Cosentino S, et al. Diagnostics (Basel).

Lab values

  • Blood pressure: 150/85 mm Hg (ref: <120 /80 mm Hg)
  • Cardiac troponin I: 0.05 ng/mL (ref: ≤0.04 ng/mL)
  • eGFR: 98 mL/min/1.73 m2 (ref: >90 mL/min/1.73 m2)
  • Serum creatinine: 0.8 mg/dL (ref: 0.70–1.30 mg/dL)
  • ESR: 90 mm/hr (ref: <30 mm/hr)
  • SpO2: 85% (ref: ≥95%)
  • Serology: +c-ANCA, High PR3-ANCA >7.0 AU/mL (ref: 0.0-0.9 AU/mL)

Possible diagnosis

  • Severe active GPA, with persistent ENT involvement

Potential treatment decision

  • At hospital: Glucocorticoids as needed; rituximab on Day 1; started on a 5-day supply of TAVNEOS® with direct hospital pharmacy dispensing; treatment continuity maintained upon discharge to clinic
  • After discharge: Continued on TAVNEOS® 30 mg BID, glucocorticoids as needed, rituximab maintenance
+c-ANCA and +PR3-ANCA = positive for antineutrophil cytoplasmic antibodies; BID = twice daily; c-ANCA = cytoplasmic-ANCA; CT = computed tomography; eGFR = estimated glomerular filtration rate; ENT = ear, nose, and throat; ESR = erythrocyte sedimentation rate; GPA = granulomatosis with polyangiitis; PR3 = proteinase 3; SpO2 = oxygen saturation rate.
Persistent Disease Activity, Severe Active GPA
Hypothetical patient with persistent disease activity

(Hypothetical patient)

Patient with Persistent Disease Activity, Severe Active GPA:
Add TAVNEOS®

Hypothetical patient with persistent disease activity

(Hypothetical patient)

Patient characteristics

59-year-old male, dental technician
Proud of sustainable gardening and enjoys cooking “farm to table” for his family
Planning a backyard greenhouse

The following profile shows a hypothetical patient and provides some common patient characteristics you may see in patients who you may consider treating with TAVNEOS®. It is informational only and should not replace your clinical decision-making regarding diagnoses and treatment. Healthcare providers are solely responsible for clinical decisions.

History of present illness

  • GPA diagnosis 12 months prior upon presenting to rheumatologist, based on presence of extreme fatigue, fever, unresolved cough, hearing loss, chest CT indicating bilateral infiltrate with ground-glass opacity, and ANCA-positive serology
  • Previous induction therapy: Rituximab (375 mg/m2/week for 4 weeks) + glucocorticoids with a standard dose taper + PJP prophylaxis
  • Maintenance with rituximab + 7.5 mg of prednisone but unable to taper any further even at 12-month mark due to persistent symptoms

Current presentation

Presents with lingering cough, chronic sinusitis, nasal crusting, and fatigue

Scans

CT reveals complete opacification of left front and left sphenoid sinus
Example of CT scan of left front and left sphenoid sinus
Image used with permission from Lakhani DA, et al. Radiol Case Rep.

Lab values

  • eGFR: 76 mL/min/1.73 m2 (ref: >90 mL/min/1.73 m2)
  • Serum creatinine: 1.0 mg/dL (ref: 0.70–1.30 mg/dL)
  • ESR: 84 mm/hr (ref: <30 mm/hr)
  • Serology: +PR3-ANCA >2.0 AU/mL (ref: 0.0-0.9 AU/mL)

Possible diagnosis

  • Severe active GPA with persistent ENT involvement

Potential treatment decision

  • Added TAVNEOS® to maintenance regimen with goal of reducing prednisone dose
CT = computed tomography; eGFR = estimated glomerular filtration rate; ENT = ear, nose, and throat; ESR = erythrocyte sedimentation rate; GPA = granulomatosis with polyangiitis; PJP = Pneumocystis jirovecii pneumonia; PR3 = proteinase 3.
Relapsing Patient, Severe Active MPA
Hypothetical relapsing patient with severe active MPA at the clinic setting

(Hypothetical patient)

Patient with Relapsing, Severe Active MPA: Add TAVNEOS®

Patient characteristics

41-year-old female, real estate agent
Owner/operator of commercial and residential real-estate franchise with ambitious growth goals

The following profile shows a hypothetical patient and provides some common patient characteristics you may see in patients who you may consider treating with TAVNEOS®. It is informational only and should not replace your clinical decision-making regarding diagnoses and treatment. Healthcare providers are solely responsible for clinical decisions.

History of present illness

  • Diagnosed with MPA 2 years prior
  • Initial induction: Induced with rituximab; patient showed sensitivity, moved to cyclophosphamide; standard-dose glucocorticoids
  • Current maintenance therapy: azathioprine + 5 mg glucocorticoids with monthly monitoring
  • Baseline lab values from last follow-up:
  • eGFR: 70 mL/min/1.73 m2 (ref: >90 mL/min/1.73 m2)
  • Serum creatinine: 1.1 mg/dL (ref: 0.59 – 1.04 mg/dL)
  • ESR: 60 mm/hr (ref: 0-30 mm/hr)
  • CRP: 18 mg/L (ref: <3 mg/L)
  • Urinalysis: 4 red blood cell casts (ref: <2) and nephritic range proteinuria: 3 mg/24 hr (ref: <1 mg/24 hr)
  • ANCA: +p-ANCA, +MPO-ANCA (ref: 0.0-0.9 AU/mL)
Hypothetical relapsing patient with severe active MPA at the clinic setting

(Hypothetical patient)

Current presentation

Presents at the clinic setting with slow hearing loss, coughing, wheezing, photophobia, blurred vision, and renal involvement indicating underlying severe disease

Scans

Eye examination: reveals scleritis
Example of eye exam with scleritis
Image used with permission from Macarie SS, Kadar A. Rom J Ophthalmol.

Lab values

  • eGFR: 51 mL/min/1.73 m2 (ref: >90 mL/min/1.73 m2)
  • Serum creatinine: 1.4 mg/dL (ref: 0.50-1.10 mg/dL)
  • ESR: 60 mm/hr (ref: <20 mm/hr)
  • Urinalysis: 3 red blood cell casts (ref: <2) and nephritic range proteinuria: 2.5 mg/24 hr (ref:
    <1 mg/24 hr)
  • CRP: 25 mg/L (ref: Low risk: <1.0 mg/L; Average risk: 1.0–3.0 mg/L; High risk:
    >3.0 mg/L)
  • SpO2: 90% (ref: ≥95%)
  • Serology: +p-ANCA, High MPO-ANCA >3.0 AU/mL (ref: 0.0-0.9 AU/mL)

Possible diagnosis

  • Relapsing severe active MPA with ENT, ocular, and renal involvement

Potential treatment decision

  • Patient expressed reservations about increasing prednisone again. Added TAVNEOS® to maintenance instead of increasing glucocorticoids or starting on cyclophosphamide
CRP = C-reactive protein; eGFR = estimated glomerular filtration rate; ENT = ear, nose, and throat; ESR = erythrocyte sedimentation rate; MPA = microscopic polyangiitis; MPO-ANCA = myeloperoxidase (MPO)-ANCA; p-ANCA = perinuclear-ANCA; SpO2 = oxygen saturation rate.

For your patients who could benefit from TAVNEOS®,
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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...