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Prescribing Information Tezspire®▼(tezepelumab)
Adverse Event Reporting
Safety Information

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TEZSPIRE® (tezepelumab): Patient Profiles
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TEZSPIRE® (tezepelumab): patient profiles

See full indication

TEZSPIRE is the first & only licensed biologic that treats across phenotypes and irrespective of key clinical biomarker levels*1-9

*Eosinophilic and non-eosinophilic, allergic and non-allergic phenotypes; without a minimum biomarker level (bEOS, IgE, or FeNO).

Consider TEZSPIRE your first choice for eligible patients with severe, uncontrolled asthma

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Allergic and eosinophilic Patient2,3,9

 

Learn more
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Patient with blood Eosinophils 
(beos) <300 cells/μl2,10

Learn more

 

Not actual patients. For illustrative purposes only.

Allergic and eosinophilic patient2,3,9

amanda

Not an actual patient. For illustrative purposes only.

There are many different triggers that can cause me 
to have an asthma attack and my work makes it worse.
I can't afford to take more time off.

 

  • Triggers: Cat dander, dust mites, viruses, changes
in weather
  • Self-employed hairdresser; enjoys walking on days off
  • Allergic asthma diagnosed at 12 years of age
  • 3 OCS bursts in ≤12 months while on MD-HD ICS/LABA
  • Total IgE: 320 IU/mL
  • bEOS count: 350 cells/µL

Pooled post hoc analysis of PATHWAY and NAVIGATOR: AAER vs placebo over 52 weeks; bEOS ≥300 cells/μL and FEIA positive

 

seventy-one

 

AAER RELATIVE RISK REDUCTION VS PLACEBO2,3,9

 

TEZSPIRE 0.69 (n=181) vs placebo 2.36 (n=179) RR=0.29, 95% CI: 0.21-0.41, ARR: 1.67

In addition, TEZSPIRE observed a reduction in key clinical biomarkers; bEOS, FeNO AND IgE (NAVIGATOR, additional secondary endpoint)2,10

 

Responses may vary. Please refer to SmPC before initiation.

Patients with a history of anaphylaxis should be monitored for an appropriate time after administration.

Patient with bEOS <300 cells/µ2,10

darren

Not an actual patient. For illustrative purposes only.

I had exhausted all treatment options, yet was still
experiencing asthma attacks. Biologics were previously
not an option for me.

 

  • Triggers: Viruses, smoke, changes in weather
  • Employed as electrician
  • Symptoms: Cough and wheezing
  • 3 OCS bursts in ≤12 months while on MD-HD
ICS/LABA
  • Total IgE: Unknown
  • bEOS count: 180 cells/µL

PRIMARY ENDPOINT OF NAVIGATOR*: AAER vs placebo over 52 weeks; patients with
baseline bEOS <300 cells/µL

 

fourty-one

 

AAER RELATIVE RISK REDUCTION VS PLACEBO†2,10

 

TEZSPIRE 1.02 (n=309) vs placebo 1.73 (n=309) RR=0.59, 95% CI:0.46 – 0.75; P<0.001 , ARR: 0.71

In NAVIGATOR (primary endpoint) TEZSPIRE significantly reduces exacerbations in the overall population and in patients with bEOS <300 cells/µL vs placebo2,10

 

Responses may vary. Please refer to SmPC before initiation.
Patients with a history of anaphylaxis should be monitored for an appropriate time after administration.

*In NAVIGATOR, a phase 3, 52-week, placebo-controlled trial (N=1059), TEZSPIRE (AAER 0.93) led to a relative risk reduction in exacerbations by 56% vs placebo (AAER 2.10), RR 0.44 CI:0.37-0.53; p<0.001; ARR=1.17. In patients with a bEOS <300, TEZSPIRE (AAER 1.02) led to a relative risk reduction in exacerbations by 41% vs placebo (AAER 1.73), RR 0.59 CI:0.46-0.75; p<0.001; ARR=0.71. In PATHWAY, a phase 2, 52-week, placebo-controlled trial (N=550; 137 patients were treated with the approved 210 mg dose), TEZSPIRE (AAER 0.20) led to a relative risk reduction in exacerbations by 71% vs placebo (AAER 0.72) (95% CI:54-82; p<0.001; ARR=0.52). All patients received SOC (MD or HD ICS + additional controller).1,3
†In a pooled analysis of PATHWAY and NAVIGATOR, AAER was 0.84 for TEZSPIRE (n=379) vs 1.62 for placebo (n=382) in patients with bEOS <300 cells/μL. All patients received SOC (MD or HD ICS + additional controller).2,3,9

bird-image

See safety profile

TEZSPIRE's safety and tolerability profile has been studied
in a clinical trial programme.

 

Please refer to full prescribing information including special warnings and precautions for use of TEZSPIRE. To report an adverse event associated with use of TEZSPIRE, please use the link at the bottom of the page.

Explore Now

TEZSPIRE (tezepelumab) is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment1

AAER=annualised asthma exacerbation rate; ARR=absolute risk reduction; bEOS=blood eosinophils; CI=confidence interval; FEIA=fluorescent enzyme immunoassay; FeNO=fractional exhaled nitric oxide; HD=high dose; ICS=inhaled corticosteroid; IgE=immunoglobulin E; LABA=long-acting β2-agonist; MD=medium dose; RR=rate ratio; SOC=standard of care.

 

  1. Tezspire (tezepelumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/14064/smpc (last accessed: November 2024).
  2. Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800-1809.
  3. Corren J, Parnes JR, Wang L, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377(10):936-946.
  4. Nucala (mepolizumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/10563/smpc (last accessed: July 2024).
  5. Cinqaero (reslizumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/4370/smpc (last accessed: July 2024).
  6. Fasenra (Benralizumab). Summary of Product Characteristics. 2023. Available at: https://www.medicines.org.uk/emc/product/10559/smpc (last accessed: July 2024).
  7. Dupixent (dupilumab). Summary of Product Characteristics. 2023. Available at: https://www.medicines.org.uk/emc/product/8553/smpc (last accessed: July 2024).
  8. Xolair (omalizumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/4725/smpc (last accessed: July 2024).
  9. Corren J, Menzies-Gow A, Chupp G, et al. Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Studies. Am J Respir Crit Care Med. 2023.
  10. Menzies-Gow A, Corren J, Bourdin A, et al. Supplementary Appendix. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800-1809.

 

GB-56891 | November 2024

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling ‌‌‌0‌‌‌8‌‌‌‌‌0‌‌‌‌0‌‌‌ ‌‌7‌‌‌‌‌‌8‌‌‌3‌‌‌ ‌‌0‌‌‌‌‌0‌‌‌‌3‌‌‌‌3‌‌‌.

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