Tezspire Adverse Reactions

Overall summary of the safety profile: In clinical studies in patients with severe asthma, the most commonly reported adverse reaction during treatment were arthralgia and pharyngitis.
Adverse Drug Reactions: A total of 739 patients with uncontrolled, severe asthma received at least one dose of TEZSPIRE in 3 randomised, placebo-controlled, multicentre trials of 48 to 52 weeks duration (Trial 1 [PATHWAY], Trial 2 [NAVIGATOR], and Trial 3 [SOURCE]). The pooled safety population (Trial 1 and Trial 2) consists of 665 adults and adolescents who received at least one dose of TEZSPIRE during the two placebo-controlled clinical studies of 52 weeks duration (Table 5). The adverse reactions with tezepelumab seen in Trial 3 were similar to the pooled safety population of Trial 1 and Trial 2.
Adverse drug reactions (ADRs) are organised by MedDRA System Organ Class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from available data). (See Table 5.)

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Summary of post-marketing data: The following adverse reactions have been identified during post approval use of TEZSPIRE. It is generally not possible to reliably determine the frequency because such reactions have been reported spontaneously from a population of uncertain size. The frequency of these adverse reactions is therefore 'not known' (cannot be estimated from available data).
Immune system disorders: Anaphylaxis.
Description of selected adverse reaction: Injection site reactions: In the pooled safety population, 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 SC every 4 weeks (Q4W) compared with 3.1% in patients treated with placebo.