Breztri Aerosphere Drug Interactions

No formal drug interaction studies have been performed with BREZTRI AEROSPHERE.
COPD medicinal products: Co-administration of BREZTRI AEROSPHERE with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products has not been studied and is not recommended.
Metabolic interactions: The metabolism of budesonide is primarily mediated by CYP3A4. Co-treatment with strong CYP3A inhibitors, e.g. itraconazole, ketoconazole, HIV protease inhibitors and cobicistat-containing products, are expected to increase the risk of systemic side effects (see Precautions and Pharmacology: Pharmacokinetics under Actions). This is of limited clinical importance for short-term (1-2 weeks) treatment, but should be taken into consideration during long-term treatment with a strong CYP3A4 inhibitor.
Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms. In-vitro glycopyrronium is a substrate for the renal transporters OCT2 and MATE1/2K. The effect of cimetidine, a probe inhibitor of OCT2 and MATE1, on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 22% and a slight decrease in renal clearance by 23% due to co-administration of cimetidine.
Formoterol does not inhibit the CYP450 enzymes at therapeutically relevant concentrations (see Pharmacology: Pharmacokinetics under Actions). Budesonide and glycopyrronium do not inhibit or induce CYP450 enzymes at therapeutically relevant concentrations (see Pharmacology: Pharmacokinetics under Actions).
Drug-induced hypokalaemia: Possible initial hypokalaemia may be potentiated by concomitant medications, including non-potassium sparing diuretics.
β-adrenergic blockers: Beta-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol.
Other pharmacodynamic interactions: BREZTRI AEROSPHERE should be administered with caution to patients being treated with medicinal products known to prolong the QTc-interval (see Precautions).