Tezspire Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions during treatment are arthralgia (3.8%) and pharyngitis (4.1%).
Tabulated list of adverse reactions: Table 5 presents the adverse reactions from clinical studies in patients with severe asthma, whereby a total of 665 patients received at least one dose of Tezspire in trials of 52 weeks duration, and from post-marketing experience.
The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 5.)

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Description of selected adverse reactions: Injection site reactions: In the pooled safety data from PATHWAY and NAVIGATOR, injection site reactions (e.g. injection site erythema, injection site swelling, injection site pain) occurred at a rate of 3.8% in patients treated with tezepelumab 210 mg subcutaneous every 4 weeks (Q4W).
Paediatric population: A total of 82 adolescents aged 12 to 17 with severe, uncontrolled asthma were enrolled in the 52-week Phase 3 NAVIGATOR study (see Pharmacology: Pharmacodynamics under Actions). The safety profile in adolescents was generally similar to the overall study population.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are recommended to report any suspected adverse reactions to the Drug Office of Department of Health and AstraZeneca.