TEZSPIRE®▼ (tezepelumab) Safety & Side Effects

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TEZSPIRE^® (tezepelumab): safety & side effects

The safety profile for TEZSPIRE was consistent across PATHWAY (Phase IIb) and NAVIGATOR (Phase III), both randomised placebo-controlled trials^1-3*

Pooled analysis of PATHWAY and NAVIGATOR

ADVERSE REACTIONS^1,4	TEZSPIRE n=665 %	Placebo n=669 %
Pharyngitis^†	4.1	2.7
Arthralgia	3.8	2.4
Injection site reaction	3.8	3.1
Rash^‡	1.7	1.3

In the pooled safety data from PATHWAY and NAVIGATOR, the most commonly reported adverse reactions during treatment were arthralgia and pharyngitis.¹

In the pooled safety data 74.7% patients in the TEZSPIRE group (total n=665) and 77.7% in the placebo group (total n=669) reported adverse events and 9.8% and 13.6% serious adverse event respectively.⁴

Any AE leading to discontinuation was 2% in the TEZSPIRE group and 3% in the placebo group.⁴

In PATHWAY and NAVIGATOR, the safety profile of TEZSPIRE versus placebo was also demonstrated by:¹
- No increase in anti-drug antibodies^2,3
- No increase in bEOS
- No increased risk of serious infection
Interactions: the use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE¹

*PATHWAY (N=550); NAVIGATOR (N=1059). All patients received SOC (MD or HD ICS + additional controller).^1-3
†Pharyngitis (including pharyngitis, pharyngitis bacterial, pharyngitis streptococcal, and viral pharyngitis).¹
‡Rash (including rash, rash pruritic, rash erythematous, rash maculo-papular, rash macular, and rash papular).¹
Note: Clinically relevant adverse events (rash, injection site reaction) are also presented.

Additional safety information can be found in the full SmPC.

Contraindications, warnings and precautions

Tezspire is contraindicated in patients who have known hypersensitivity to tezepelumab or to any of its excipients listed in Summary of Product Characteristics.

Tezspire should not be used to treat acute asthma exacerbations.
Asthma-related symptoms or exacerbations may occur during treatment. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Abrupt discontinuation of corticosteroids after initiation of therapy is not recommended. Reduction in corticosteroid doses, if appropriate, should be gradual and performed under the supervision of a physician.

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity reactions (e.g. anaphylaxis, rash) may occur following administration of tezepelumab. These reactions may occur within hours of administration, but in some instances have a delayed onset (i.e. days).
A history of anaphylaxis unrelated to tezepelumab may be a risk factor for anaphylaxis following Tezspire administration. In line with clinical practice, patients should be monitored for an appropriate time after administration of Tezspire.
In the event of a serious hypersensitivity reaction (e.g. anaphylaxis), administration of tezepelumab should be discontinued immediately and appropriate treatment as clinically indicated should be initiated.

Blocking thymic stromal lymphopoietin (TSLP) may theoretically increase the risk of serious infections. In placebo-controlled studies, no increase in serious infections was observed with tezepelumab.
Patients with pre-existing serious infections should be treated before initiating therapy with tezepelumab. If patients develop a serious infection while receiving tezepelumab treatment, therapy with tezepelumab should be discontinued until the serious infection resolves.
There is currently no data on re-treatment of patients who develop a serious infection

In a long-term clinical study, a numerical imbalance in serious cardiac adverse events was observed in patients treated with tezepelumab compared to placebo. No causal relationship between tezepelumab and these events has been established, nor has a patient population at risk of these events been identified.
Patients should be advised of signs or symptoms suggestive of a cardiac event (for example, chest pain, dyspnoea, malaise, feeling lightheaded or faint) and to seek immediate medical attention if such symptoms occur. If patients develop a serious cardiac event while receiving tezepelumab treatment, therapy with tezepelumab should be discontinued until the acute event stabilises.
There is currently no data on re-treatment of patients who develop a serious cardiac event or serious infection.

TSLP may be involved in the immunological response to some helminth infections. Patients with known helminth infections were excluded from participation in clinical trials. It is unknown if tezepelumab may influence a patient’s response against helminth infections.
Patients with pre-existing helminth infections should be treated before initiating therapy with tezepelumab. If patients become infected while receiving treatment and do not respond to anti-helminth treatment, therapy with tezepelumab should be discontinued until infection resolves.

No interaction studies have been performed.
The use of live attenuated vaccines should be avoided in patients receiving tezepelumab.

There are no fertility data in humans.
Avoid during pregnancy unless the expected benefit to the patient is greater than any possible risk to the foetus or baby. It is unknown whether tezepelumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period. For this specific period, a decision should be made whether to discontinue/abstain from tezepelumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman. Afterwards, tezepelumab could be used during breast-feeding if clinically needed.

TEZSPIRE dosing

One dose every 28 days for all eligible patients¹

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; AE=adverse event; bEOS=blood eosinophils; SOC=standard of care; MD=medium dose; HD=high dose; ICS=inhaled corticosteroid; SmPC=Summary of Product Characteristics.

Tezspire (tezepelumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/14064/smpc (last accessed: November 2024).
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.
Corren J, Parnes JR, Wang L, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377(10):936-946.
AstraZeneca UK Ltd. Data on File. ID: REF-257378. December 2024.

GB-56892 | 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.

This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.

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TEZSPIRE® (tezepelumab): safety & side effects

The safety profile for TEZSPIRE was consistent across PATHWAY (Phase IIb) and NAVIGATOR (Phase III), both randomised placebo-controlled trials1-3*

Pooled analysis of PATHWAY and NAVIGATOR

Contraindications, warnings and precautions

Contraindications1

General Precautions1

Traceability1

Hypersensitivity reactions1

Serious infections1

Serious cardiac events1

Parasitic (helminth) infection1

Interactions1

Pregnancy and Lactation1

TEZSPIRE dosing

One dose every 28 days for all eligible patients1

Abbreviations and References

TEZSPIRE^® (tezepelumab): safety & side effects

The safety profile for TEZSPIRE was consistent across PATHWAY (Phase IIb) and NAVIGATOR (Phase III), both randomised placebo-controlled trials^1-3*

One dose every 28 days for all eligible patients¹