Safety profile

TAVNEOS-based regimen has a favourable safety profile1

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

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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 the TAVNEOS- and GC-based regimen1

The number of SAEs (excluding events of worsening vasculitis) was 33% lower in the TAVNEOS-based regimen vs GC-based regimen11

 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

Subjects with any AE potentially related to GCs (%)

  • Investigators blinded assessment
  • 110 (66.3)
  • 132 (80.5)
symptoms

In a pooled safety analysis, the AE patient rst 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 xed oral dose with no additional monitoring beyond standard disease management 2*

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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*TAVNEOS is administered as a fixed-dose regimen, and it is not necessary to monitor organ impairment and undertake additional analysis beyond what is needed for standard disease management. Hepatic enzymes, total bilirubin and white blood cell count must be monitored.1 Please consult Summary of Product Characteristics for further information.

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 discontinuation2

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;AZA, 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 EU SmPC July 2023. 3. Jayne D, et al. J Am Soc Nephrol 2022:33.