Adverse reactions : תופעות לוואי

4.8 Undesirable effects

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 1 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.

Table 1               List of adverse reactions
System organ class                                           Adverse reactions               Frequency a
Infections and infestations                                  Pharyngitis                     Common Immune system disorders                                      Hypersensitivity        Not known (including anaphylactic reaction)
Skin and subcutaneous tissue disorders                       Rashb                   Common Musculoskeletal and connective tissue disorders              Arthralgia                      Common General disorders and administration site                    Injection site reactionc        Common conditions a Pharyngitis was defined by the following grouped preferred terms: pharyngitis, pharyngitis bacterial, pharyngitis streptococcal and viral pharyngitis.
b Rash was defined by the following grouped preferred terms: rash, rash pruritic, rash erythematous, rash  maculo-papular,
rash macular.
c See ‘Description of selected adverse reactions’.


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 section 5.1). The safety profile in adolescents was generally similar to the overall study population.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il