Breztri Aerosphere Adverse Reactions

Summary of the safety profile: As BREZTRI AEROSPHERE contains budesonide, glycopyrronium and formoterol, the type and severity of adverse reactions associated with each of the components may be expected with BREZTRI AEROSPHERE.
The safety evaluation of the pivotal program for BREZTRI AEROSPHERE 160/7.2/5.0 included 639 subjects with COPD in one 24-week lung function trial, and a long-term safety extension study of 28 weeks, and 2144 subjects in one 52-week exacerbation trial. In addition, 2137 subjects in the 52-week exacerbation trial received BGF MDI 80/7.2/5.0.
Tabulated summary of adverse reactions: 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). (See Table 5.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Pneumonia: In KRONOS (see Pharmacology: Pharmacodynamics under Actions), the incidence of confirmed pneumonia was 1.9% with BREZTRI AEROSPHERE 160/7.2/5.0, 1.9% with budesonide and formoterol fumarate dihydrate [BFF MDI 160/5.0 mcg], and 1.6% with glycopyrronium and formoterol fumarate dihydrate [GFF MDI 7.2/5.0 mcg].
In ETHOS (see Pharmacology: Pharmacodynamics under Actions), the incidence of confirmed pneumonia was 4.2% with BREZTRI AEROSPHERE 160/7.2/5.0, 3.5% with BGF MDI 80/7.2/5, 4.5% with BFF MDI 160/5.0 mcg and 2.3% with GFF MDI 7.2/5.0 mcg.