Seebri Breezhaler Adverse Reactions

Summary of the safety profile: The safety and tolerability of SEEBRI BREEZHALER has been explored at the recommended dose of 50 μg once-daily in 1353 COPD patients. Of these, 842 patients have been treated for at least 26 weeks, and 351 patients for at least 52 weeks.
The safety profile is characterized by symptoms related to the anticholinergic effect including dry mouth while other gastrointestinal effects and signs of urinary retention were infrequent. Adverse drug reactions related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis. At the recommended dose SEEBRI BREEZHALER is devoid of effects on blood pressure or heart rate.
Tabulated summary of adverse drug reactions from clinical trials: Adverse drug reactions reported during the first 6 months of two pooled pivotal Phase III trials of 6- and 12-months duration are listed by MedDRA system organ class (Table 1). Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100). (See Table 1.)


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In the 12-month study the following additional events were more frequent on SEEBRI BREEZHALER than on placebo: nasopharyngitis (9.0 vs 5.6%), vomiting (1.3 vs 0.7%), musculoskeletal pain (1.1 vs 0.7%), neck pain (1.3 vs 0.7%), diabetes mellitus (0.8 vs 0%).
Adverse drug reactions from spontaneous reports and literature cases (frequency not known): The following adverse drug reaction has been reported with SEEBRI BREEZHALER in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. (See Table 2.)


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Description of selected adverse drug reactions: The most common anticholinergic adverse reaction was dry mouth. The majority of the reports of dry mouth were suspected to be drug related and of mild degree, none was severe. Rash was uncommon and generally mild.
Special populations: In elderly patients above 75 years of age the frequencies of urinary tract infection and headache were higher on SEEBRI BREEZHALER than on placebo, with 3.0 versus 1.5% and 2.3 versus 0%, respectively.