Safety profile

The most common adverse reactions observed in a pivotal phase 3 study in patients treated with a TAVNEOS-based regimen:2

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Nausea 23.5%

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Diarrhoea 15.1%

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Headache 20.5%

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Vomiting 15.1%

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Decreased white blood cell count 18.7%

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Upper respiratory tract infection 14.5%

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Nasopharyngitis 15.1%

The most common serious adverse reactions are liver function abnormalities (5.4%) and pneumonia (4.8%)2

In post marketing setting: drug-induced liver injury and vanishing bile duct syndrome have been reported (frequency unknown)2

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Reducing relapses
symptoms

TAVNEOS is a substrate of CYP3A4, but clinically relevant interactions are unlikely when TAVNEOS is co-administered with inducers or inhibitors of this enzyme2

Comparable safety results

Numerically similar incidence of SAEs observed in TAVNEOS- and GC-based regimen1

The number of SAEs (excluding events of worsening vasculitis) was 33% higher in the GC-based regimen vs the TAVNEOS-based regimen1

 TAVNEOS-BASED REGIMEN (n=166)GC-BASED REGIMEN (n=164)

Treatment-emergent adverse events (TEAEs)

  • Number of any TEAEs
  • Subject incidence (%) of TEAEs
  • 1779
  • 164 (98.8)
  • 2139
  • 161 (98.2)

Serious adverse events (SAEs)

  • Number of SAEs
  • Subject incidence (%) of SAEs
  • Number of SAEs related to vasculitis worsening
  • Number of SAEs not related to vasculitis worsening
  • 116
  • 70 (42.2)
  • 18
  • 98
  • 166
  • 74 (45.1)
  • 36
  • 130

Deaths

  • Total number of deaths (%)
  • 2 (1.2)
  • 4 (2.4)

Infection

  • Number of serious infection events
  • 25
  • 31

AEs potentially related to GCs

  • Subject incidence (%)
  • 110 (66.3)
  • 132 (80.5)
symptoms

In a pooled safety analysis, the AE patient first incidence rate, AE rate, SAE rate, infection event rate, and WBC count decrease AE rate were statistically lower in the TAVNEOS-based regimen vs GC-based regimen3

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Fixed oral dosing

TAVNEOS is taken as a fixed oral dose2

TAVNEOS should be taken as follows:2

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30 mg TAVNEOS

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Taken twice-daily

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With food

Hepatic transaminases, total bilirubin and white blood cell count must be monitored as clinically indicated, and as part of the routine follow-up of the patient’s underlying condition2*†

symptoms

Treatment regimen in combination with immunosuppressants
(RTX or CYC/AZA)2

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*Treatment must be re-assessed clinically and temporarily stopped if ALT or AST is >3x ULN. Treatment must be temporarily stopped if ALT or AST is >5× ULN. Please consult Summary of Product Characteristics for information about permanent discontinuation.2

†Treatment must be temporarily stopped if a patient develops leukopenia (white blood cell count <2×109/L) or neutropenia (neutrophils <1×109/L) or lymphopenia (lymphocytes <0.2×109/L).2

AAV, ANCA-associated vasculitis; AE, adverse event; ALT, alanine transaminase; ANCA, anti-neutrophil cytoplasmic antibody; AST, aspartate transaminase; AZA, azathioprine; CYC, cyclophosphamide; CYP3A4, Cytochrome P450 3A4; GC, glucocorticoid; GPA, granulomatosis with polyangiitis; MOA, mechanism of action; MPA, microscopic polyangiitis; RTX, rituximab; SAE, serious adverse event; TEAE, treatment-emergent adverse event; ULN, upper limit of normal; WBC, white blood cell.

 

1.Jayne D, et al. N Engl J Med 2021;384(7):599–609. 2. TAVNEOS NOR SmPC July 2024. 3. Jayne D, et al. J Am Soc Nephrol 2022:33.