Overall Summary of Adverse Drug Reactions: In clinical studies, in patients with severe asthma with eosinophilic phenotype the most commonly reported adverse reaction during treatment was headache and pharyngitis.
Adverse Drug Reactions: A total of 1,663 patients with uncontrolled severe asthma received benralizumab during the two placebo-controlled Phase 3 clinical studies of 48 to 56 weeks duration. Table 9 presents the adverse reactions from the two placebo-controlled studies in patients receiving benralizumab 30 mg every 4 weeks for the first 3 doses, and then every 8 weeks thereafter.
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 9.)
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Description of selected adverse reaction: Injection site reactions: In placebo-controlled studies, injection site reactions (e.g., pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with the indicated benralizumab dose compared with 1.9% in patients treated with placebo.
Summary of post-marketing data: The following adverse reactions have been identified during post approval use of FASENRA. It is generally not possible to reliably determine the frequency because such reactions have been reported spontaneously from a population of uncertain size and therefore represent reporting rates. The frequency of these adverse reactions is therefore 'not known' (cannot be estimated from available data).
Immune system disorders: Anaphylaxis (defined by the grouped preferred terms: 'Anaphylactic reaction', 'Angioedema').
Long-term safety: In a 56-week double blind, randomized, parallel-group extension trial (Trial 4) in patients with asthma from Trials 1, 2 and 3, 842 patients were treated with FASENRA at the recommended dose and remained in the trial. The overall adverse event profile was similar to the asthma trials described previously. Additionally, in an open-label safety extension trial (Trial 5) in patients with asthma from previous trials, 226 patients were treated with FASENRA at the recommended dose for up to 43 months. Combined with the treatment period in previous studies, this corresponds to median follow-up of 3.4 years (range 8.5 months - 5.3 years). The safety profile during this follow-up period was consistent with the known safety profile of FASENRA.