TAVNEOS

TAVNEOS is an FDA-registered drug product whose active ingredient is AVACOPAN. It is labelled by ChemoCentryx, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 73556-168, application NDA214487, label effective 20260602. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing AVACOPAN are most often described in connection with: indicated adjunctive, treatment adult, severe active, anti-neutrophil cytoplasmic, autoantibody anca, associated vasculitis, polyangiitis gpa, mpa combination. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE TAVNEOS 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. TAVNEOS is a complement 5a receptor (C5aR) antagonist 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. ( 1 )

2 DOSAGE AND ADMINISTRATION The recommended dosage is 30 mg (three 10 mg capsules) twice daily, with food. ( 2 ) 2.1 Recommended Evaluations Prior to Treatment Initiation Before initiating TAVNEOS, perform the following evaluations: Liver Function Tests: Obtain liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and total bilirubin) before initiating TAVNEOS. TAVNEOS is not recommended for use in patients with cirrhosis, especially those with severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7) ] . Hepatitis B (HBV) Serology: Screen patients for HBV infection by measuring HBsAg and anti-HBc . For patients with evidence of prior or current HBV infection, consult with a physician with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before or during treatment with TAVNEOS [see Warnings and Precautions (5.3) ] . 2.2 Recommended Dosage and Administration The recommended dose of TAVNEOS is 30 mg (three 10 mg capsules) twice daily, with food. Advise patients that TAVNEOS capsules should not be crushed, chewed or opened. If a dose is missed, instruct the patient to wait until the usual scheduled time to take the next regular dose. Instruct the patient not to double the next dose. 2.3 Dosage Modifications Due to CYP3A4 Inhibitors Reduce the dosage of TAVNEOS to 30 mg once daily when used concomitantly with strong CYP3A4 inhibitors.

4 CONTRAINDICATIONS TAVNEOS is contraindicated in patients with serious hypersensitivity reaction to avacopan or to any of the excipients [see Warnings and Precautions (5.2) ] . Serious hypersensitivity to avacopan or to any of the excipients. ( 4 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Hepatitis B Virus (HBV) Reactivation [see Warnings and Precautions (5.3) ] Serious Infections [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%) are: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because the clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The identification of potential adverse drug reactions was based on safety data from the phase 3 clinical trial in which 330 patients with ANCA-associated vasculitis were randomized 1:1 to either TAVNEOS or prednisone [see Clinical Studies (14) ] . The mean age of patients was 60.9 years (range of 13 to 88 years), with a predominance of men (56.4%) and Caucasians (84.2%). The cumulative exposure to TAVNEOS was 138.7 patient-years. Additionally, two phase 2 trials were conducted in ANCA-associated vasculitis. The cumulative clinical trial exposure from the phase 2 and 3 trials equals 212.3 patient-years. The most frequent serious adverse reactions reported more frequently in patients treated with TAVNEOS than with prednisone were pneumonia (4.8% TAVNEOS vs. 3.7% prednisone), GPA (3.0% TAVNEOS vs. 0.6% prednisone), acute kidney injury (1.8% TAVNEOS vs. 0.6% prednisone), and urinary tract infection (1.8% TAVNEOS vs. 1.2% prednisone). Within 52 weeks, 4 patients in the prednisone treatment group (2.4%) and 2 patients in the TAVNEOS group (1.2%) died. There were no deaths in the phase 2 trials. In the phase 3 trial, seven patients (4.2%) in the TAVNEOS treatment group and 2 patients (1.2%) in the prednisone treatment group discontinued treatment due to hepatic-related adverse reactions, including hepatobiliary adverse reactions and liver enzymes abnormalities. The most frequent adverse reaction that led to drug discontinuation reported by > 1 patient and more frequently reported in patients treated with TAVNEOS was hepatic function abnormal (1.8%). The most common adverse reactions that occurred in ≥ 5% of patients and higher in the TAVNEOS group as compared with the prednisone group are listed in Table 1. Table 1. Adverse Reactions Reported in ≥ 5% of Patients and Higher in TAVNEOS Group vs. Prednisone Group in Phase 3 Trial Adverse Reaction Prednisone (N = 164) n (%) TAVNEOS (N = 166) n (%) N = number of patients randomized to treatment group in the Safety Population; n = number of patients in specified category. Nausea 34 (20.7) 39 (23.5) Headache 23 (14.0) 34 (20.5) Hypertension 29 (17.7) 30 (18.1) Diarrhea 24 (14.6) 25 (15.1) Vomiting 21 (12.8) 25 (15.1) Rash 13 (7.9) 19 (11.4) Fatigue 15 (9.1) 17 (10.2) Upper abdominal pain 10 (6.1) 11 (6.6) Dizziness 10 (6.1) 11 (6.6) Blood creatinine increased 8 (4.9) 10 (6.0) Paresthesia 7 (4.3) 9 (5.4) Hepatotoxicity and Elevated Liver Function Tests In the phase 3 trial, a total of 19 patients (11.6%) in the prednisone group and 22 patients (13.3%) in the TAVNEOS group had hepatic-related adverse reactions, including hepatobiliary adverse reactions and liver enzyme abnormalities. Study medication was paused or discontinued permanently due to hepatic-related adverse reactions in 5 patients (3.0%) in the prednisone group and 9 patients (5.4%) in the TAVNEOS group. Serious hepatic-related adverse reactions were reported in 6 patients (3.7%) in the prednisone group and 9 patients (5.4%) in the TAVNEOS group. A serious hepatic-related adverse reaction was reported in 1 patient in the TAVNEOS group in the phase 2 studies. Angioedema In the phase 3 trial, 2 patients (1.2%) in the TAVNEOS group had angioedema; one event was a serious adverse reaction requiring hospitalization. Elevated Creatine Phosphokinase In the phase 3 trial, 1 patient (0.6%) in the prednisone group and 6 patients (3.6%) in the TAVNEOS group had increased creatine phosphokinase. One TAVNEOS-treated patient discontinued treatment due to increased creatine phosphokinase. 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of TAVNEOS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or definitively establish a causal relationship to drug exposure. Hepatobiliary disorders: vanishing bile duct syndrome [ see Warnings and Precautions (5.1) ]

What is TAVNEOS used for?
1 INDICATIONS AND USAGE TAVNEOS 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. TAVNEOS is a complement 5a …

Who makes TAVNEOS?
ChemoCentryx, Inc. is the labeler of record for TAVNEOS.

What form does TAVNEOS come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is TAVNEOS prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has TAVNEOS been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.