Fasenra Adverse Reactions

Summary of the safety profile: The safety profile of benralizumab in asthma and EGPA are similar.
The most commonly reported adverse reactions during treatment in asthma are headache (8%) and pharyngitis (3%). The most commonly reported adverse reaction in EGPA is headache (17%). Cases of anaphylactic reaction of varied severity have been reported for benralizumab.
Tabulated list of adverse reactions: The following adverse reactions have been reported with benralizumab during clinical studies in asthma and EGPA 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 9.)

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Description of selected adverse reaction: Injection site reactions: In placebo-controlled asthma studies, injection site reactions (e.g. pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with the recommended benralizumab dose compared with 1.9% in patients treated with placebo. The events were transient in nature.
Long-term safety: In a 56-week 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 safety 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 a 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.
Paediatric population: There are limited data in paediatric patients. There were 108 adolescents aged 12 to 17 with asthma enrolled in the phase 3 trials (Trial 1: n=53, Trial 2: n=55). Of these, 46 received placebo, 40 received benralizumab every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received benralizumab every 4 weeks. Adolescent patients aged 12 to 17 (n=86) from Trials 1 and 2 continued the treatment with benralizumab in Trial 4 for up to 108 weeks. The frequency, type and severity of adverse reactions in the adolescent population were observed to be similar to those seen in adults.
In an open-label, uncontrolled pharmacokinetic and pharmacodynamic study of 48 weeks duration in a limited number of paediatric patients (n=28) with uncontrolled severe asthma, the safety profile for patients aged 6 to 11 years old was similar to the adult and adolescent population (see Dosage & Administration).
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 AstraZeneca.