Glycoair Breezhaler Adverse Reactions

The presentation of the safety profile is based on the experience with combination indacaterol/glycopyrronium and the individual monotherapy components.
Summary of the safety profile: The safety experience was comprised of exposure of up to 15 months at the recommended therapeutic dose (110/50 microgram).
The Phase III clinical development program consisted of 11 studies and enrolled over 10000 patients with a clinical diagnosis of moderate to very severe COPD. Safety data from 9 of these studies with treatment durations of 4 weeks or longer were pooled from 4352 patients exposed to indacaterol/glycopyrronium 110/50 microgram once-daily.
The safety profile was characterized by typical anticholinergic and beta-adrenergic symptoms related to the individual monotherapy components of the combination. Other most common adverse drug reactions related to the drug product (≥3% and greater than placebo) were headache, cough and nasopharyngitis.
At the recommended dose, the adverse drug reaction profile in patients with COPD showed clinically insignificant systemic effects of beta₂-adrenergic stimulation. Mean heart rate changes were less than one beat per min, and tachycardia was infrequent and reported at a lower rate than with placebo. Relevant prolongations of QT_cF were not detectable in comparison to placebo. The frequency of notable QT_cF intervals [i.e., >450 ms] and reports of hypokalemia were similar to placebo.
Tabulated summary of adverse drug reactions from clinical trials: Adverse drug reactions are listed by MedDRA system organ class (Table 3). The frequency of adverse drug reactions was based on a pool of 3 Phase III placebo-controlled database trials of 6 and 12 months in duration. 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); rare (≥1/10,000, <1/1,000); and very rare (<1/10,000).
Combination indacaterol/glycopyrronium showed similar adverse drug reactions as the individual monotherapy components. As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of the monotherapy components may be expected in the combination. (See Table 3.)

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Adverse drug reactions from spontaneous reports and literature cases (frequency not known): The following adverse drug reactions have been reported with indacaterol/glycopyrronium 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 4.)

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Description of selected adverse drug reactions: The most common anticholinergic adverse event was dry mouth (0.64% versus 0.45% for placebo); however, this adverse event was reported at a lower frequency with indacaterol/glycopyrronium combination than with glycopyrronium monotherapy. The majority of the reports of dry mouth were suspected to be drug related and of mild degree, none was severe. Cough was common, but usually of mild intensity.
Some serious adverse events, including hypersensitivity and ischemic heart disease, have been reported as ADRs for indacaterol administered as monotherapy. The reported frequencies for indacaterol/glycopyrronium for hypersensitivity and ischemic heart disease were 2.06% versus 1.9% for placebo and 0.67% versus 0.78% for placebo, respectively.