Indication: TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody...
Read moreIndication: 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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TAVNEOS® regimen: TAVNEOS® + rituximab, or cyclophosphamide followed by azathioprine or mycophenolate mofetil.§
Standard Therapy: prednisone-taper‡ + rituximab, or cyclophosphamide followed by azathioprine or mycophenolate mofetil.§
Prednisone-Taper: 60 mg/day tapered to 0 over 20 weeks.
If azathioprine is not tolerated.
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 26.2
Sustained remission was defined as remission at Week 26 and at Week 52 and no use of glucocorticoids for 4 weeks before Week 52, without relapse|| between Week 26 and Week 52.1,3
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 BVAS after a BVAS of 0 had been achieved.
Time to Relapse2,**
≥1 major item in the BVAS, or
≥3 minor items in the BVAS, or
1-2 minor items in the BVAS recorded at ≥2 consecutive visits
Adapted from Jayne DRW, et al. N Engl J Med. 2021;384(7):599-609.
CI = confidence interval; ST = Standard Therapy.
Least-squares mean change in eGFR from baseline to Weeks 26 and 52 in patients with renal disease at baseline based on the BVAS.
BVAS = Birmingham Vasculitis Activity Score; eGFR = estimated glomerular filtration rate.
In a subgroup analysis, patients with baseline eGFR <30 mL/min/1.73 m2 experienced a least-squares mean change in eGFR improvement:2,4,‡‡
improvement from baseline in the TAVNEOS® arm vs 38% in the Standard Therapy arm2,4
‡‡Results of prespecified subgroup analysis in the 100 patients with eGFR <30 mL/min/1.73 m2 and ≥15 mL/min/1.73 m2 at baseline. Results from this exploratory subgroup analysis should be interpreted with caution.2,3,5
Least-squares mean change in eGFR from baseline to Weeks 26 and 52 in patients with renal disease at baseline based on the BVAS.
BVAS = Birmingham Vasculitis Activity Score; eGFR = estimated glomerular filtration rate.
Based on percentage change from baseline in uACR in patients with baseline renal disease and baseline uACR >10 mg/g (52-week study period).2,3
BVAS = Birmingham Vasculitis Activity Score; ITT = intent to treat; LSM = least squares mean; SEM = standard error of the mean.
Category | Week 26 | Week 52 |
---|---|---|
Physical Component Score | TAV = 4.45 ST = 1.34 |
TAV = 4.98 ST = 2.63 |
Physical Function | TAV = 7.31 ST = 1.88 |
TAV = 9.55 ST = 4.82 |
Body Pain | TAV = 14.75 ST = 9.82 |
TAV = 16.12 ST = 11.87 |
Role-Physical|||| | TAV = 16.78 ST = 7.52 |
TAV = 17.12 ST = 12.27 |
General Health Perception | TAV = 3.12 ST = -2.89 |
TAV = 5.84 ST = -0.17 |
Category | Week 26 | Week 52 |
---|---|---|
Mental Component Score | TAV = 4.85 ST = 3.27 |
TAV = 6.39 ST = 4.69 |
Vitality | TAV = 12.03 ST = 6.42 |
TAV = 14.36 ST = 10.48 |
Mental Health | TAV = 8.29 ST = 6.84 |
TAV = 10.89 ST = 9.66 |
Role-Emotional*** | TAV = 7.32 ST = 1.40 |
TAV = 9.38 ST = 4.14 |
Social Functioning | TAV = 14.50 ST = 11.09 |
TAV = 18.06 ST = 13.56 |
As assessed by the 36-Item Short Form Health Survey (SF-36), version 2. SF-36 scores range from 0 (worst) to 100 (best).2
Scores reflect change from baseline (least squares mean ± standard error of the mean).3
Role-Physical is one of the eight SF-36 domains. It assesses the limitations in routine activities because of physical health capabilities.9
Role-Emotional is one of the eight SF-36 domains. It assesses the limitations on routine activities because of emotional factors.9
GPA = granulomatosis with polyangiitis; MPA = microscopic polyangiitis; QoL = quality of life; ST = Standard Therapy; TAV = TAVNEOS®.
Median
Mean
Glucocorticoid load decreased for patients on TAVNEOS® by10,†††
Prednisone equivalent dose per patient.
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Serious hypersensitivity to avacopan or to any of the excipients.
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.
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.
Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when coadministered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.
TAVNEOS is available as a 10 mg capsule.
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.
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...