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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Getting Your Patients Started

TAVNEOS® offers a wide range of support for patients

  • Help patients understand their insurance benefits
  • Assist eligible commercially insured patients with enrolling in the TAVNEOS® Copay Program, which can lower monthly out-of-pocket costs to as little as $0* for a month’s supply of TAVNEOS®
  • Assist with screening to provide medication to eligible patients who do not have insurance and who meet other program criteria

86%

of insured
patients
approved
regardless of formulary coverage, for TAVNEOS®1,†

≤7

Days
Time To Fill
for most patients, regardless of insurance approval2,‡

>2000

healthcare providers in the US have prescribed TAVNEOS® to their patients3,§
Represents total number of unique prescribers with one or more new Patient Enrollment Forms submitted to AssistRx, Amber, or Panther from October 2021 – May 2024.
Quick Start Program

TAVNEOS® Quick Start Program*

For newly prescribed TAVNEOS® patients, this program can initially provide up to a 30-day supply:

  • For eligible patients whose insurance plan requires a prior authorization and you believe a delay in therapy could lead to negative clinical outcomes
  • For eligible patients being discharged from an inpatient setting to support their continuity of care

To enroll your patients in the TAVNEOS® Quick Start Program:

Quick start program
Quick start program

If your patient is eligible, after the pharmacy speaks to your patient to coordinate delivery, the Quick Start supply of TAVNEOS® will be shipped directly to your patient’s home. See complete submission details below.

Helpful tips for patients enrolling in the TAVNEOS® Quick Start Program

  • Ensure all required fields on the Patient Enrollment Form are completed. Missing information can cause delays
  • If the patient has designated an alternate contact person, include their information for faster communications
*

The TAVNEOS® Quick Start program is available to adult patients whose diagnosis is aligned to the FDA-approved indication for TAVNEOS®. Additional eligibility criteria applies.

†

Eligibility criteria and program maximums apply. See www.tavneospro.com/copay for full Terms and Conditions.

‡

Based on patient approval rates from October 2021 through December 2022.

§

Based on Patient Enrollment Forms from October 2021 through May 2024.

For additional information on hospital ordering please visit the Resources and Videos section of the website.

For questions, call the TAVNEOS® Team at 1-833-TAVNEOS (1-833-828-6367) and choose option 2, Monday through Friday from 8 AM to 8 PM ET
Obtaining TAVNEOS®

Starting your patients on TAVNEOS®

Guide on how to start patients on TAVNEOS® (avacopan)

Fax completed Patient Enrollment Form (with the prescription section completed or eRx)
panther-logo
Phone: 1-833-TAVNEOS (828-6367),
Option 2, then Option 3
Fax: 1-866-312-4206
Hours: 8 AM to 8 PM ET, Monday-Friday
ePrescribe: PANTHERx Rare Pharmacy
Address: 1120 Stevenson Mill Road Suite 400 Coraopolis, PA 15108
NCPDP#: 6008002

PLEASE NOTE: TAVNEOS® is a limited-distribution specialty product available commercially to patients only through select Specialty Pharmacy providers. For hub referrals, once all information is obtained and appropriate patient support is provided, the TAVNEOS® Team will transfer the enrollment and Rx to the associated specialty pharmacy for continued support toward prescription fulfillment.

Get your patient started on TAVNEOS®:

Fax machine

Get your patient started on TAVNEOS®:

Submit the Patient Enrollment Form via fax (with the prescription section completed or eRx)

(with the prescription section completed or eRx)
Download the Patient Enrollment Form

Specialty Distributors

ASD Healthcare

Phone: 800-746-6273

Fax: 800-547-9413

Email: service@asdhealthcare.com

Online: www.asdhealthcare.com

Cardinal Health SPD

Phone: 866-476-1340

Email: GMB-SPD-CSOrderEntry @cardinalhealth.com

Online: https://orderexpress.
cardinalhealth.com

McKesson Plasma and Biologics

Phone: 877-625-2566

Fax: 888-752-7626

Email: mpborders@mckesson.com

Online: https://connect.
mckesson.com

For additional information on hospital ordering please visit the Resources and Videos section of the website.

For questions, call the TAVNEOS® Team at 1-833-TAVNEOS (1-833-828-6367) and choose option 2, Monday through Friday from 8 AM to 8 PM ET

Learn more about the financial resources available for your eligible patients on 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...