Treatment for Severe Active ANCA-Associated Vasculitis (GPA/MPA)

Combine TAVNEOS® with standard therapy to achieve and sustain remission in patients with severe active GPA or MPA¹

TAVNEOS® is the only FDA-approved adjunctive treatment for severe active GPA and MPA that targets a complement-mediated response

The precise mechanism by which TAVNEOS® exerts a therapeutic effect in patients with severe active GPA or MPA has not been definitively established.¹

Only TAVNEOS® targets C5aR and blocks the complement pathway

Multiple pathways are involved in ANCA-associated vasculitis.^2-4 TAVNEOS® blocks the complement-mediated cycle of chronic inflammation^1,4

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TAVNEOS® has data in remission and sustained remission¹

TAVNEOS® was studied in a 52-week, global, multicenter clinical trial evaluating a range of GPA and MPA manifestations^1,5

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Experience continues to grow

>8,000 patients treated^6,§
>4,000 prescribers in the US^6,**

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*Remission was defined as achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and not taking glucocorticoids for treatment of GPA or MPA within 4 weeks prior to Week 26.^{5

†}Sustained remission was defined as remission at Week 26 and Week 52 and not taking glucocorticoids for treatment of GPA or MPA for 4 weeks before Week 52, without relapse^‡ between Week 26 and Week 52.^{5

‡}Relapse was defined as the occurrence of at least 1 major item, at least 3 non-major items, or 1 or 2 non-major items for at least 2 consecutive visits based on the BVAS after a BVAS of 0 had been achieved.^{5

§}Represents total number of unique patient enrollment forms submitted to AssistRx, Amber, or Panther from October 2021 – April 2026.⁶**Represents total number of unique prescribers with one or more new patient enrollment forms submitted to AssistRx, Amber, or Panther from October 2021 – April 2026.⁶

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

TAVNEOS® can be initiated alongside, or added to, standard therapy to treat severe active GPA or MPA^1,7

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Helpful resources for you and your patients throughout their TAVNEOS® treatment journey

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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. In the postmarketing setting, vanishing bile duct syndrome (VBDS) as a consequence of liver injury, including cases with a fatal outcome, has been reported. These events occurred predominantly in Japan in patients aged 65 years and older, but VBDS may affect patients of any age or ethnicity who are receiving TAVNEOS. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. For patients of Japanese descent, consider more frequent laboratory testing: every 2 weeks after the start of therapy for the first 3 months, followed by laboratory testing every 4 weeks for the next 3 months of treatment, and as clinically indicated thereafter. If a patient receiving treatment with TAVNEOS presents with an elevation in alanine aminotransferase [ALT] or aspartate aminotransferase [AST] to >3 times the upper limit of normal (ULN), evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the ULN, or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or alkaline phosphatase ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out. Immediately and permanently discontinue TAVNEOS if VBDS is suspected. 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 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.

Combine TAVNEOS® with standard therapy to achieve and sustain remission in patients with severe active GPA or MPA1