Breztri Aerosphere Special Precautions

Deterioration of disease: If patients find the treatment ineffective, despite taking the highest recommended dose of BREZTRI AEROSPHERE, medical attention must be sought. Sudden and progressive deterioration in control of COPD is potentially life threatening and the patient should undergo urgent medical assessment. In this situation, consideration should be given to the need for increased therapy such as a course of oral corticosteroids or antibiotic treatment if an infection is present.
Transfer from oral therapy: Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Paradoxical bronchospasm: As with other inhaled medicines, administration of BREZTRI AEROSPHERE may cause paradoxical bronchospasm. If this occurs, treatment with BREZTRI AEROSPHERE should be stopped and other treatments considered.
Not for acute use: BREZTRI AEROSPHERE is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Cardiovascular effects: As for all β2-agonists, caution should be observed in patients with thyrotoxicosis and in patients with a severe cardiovascular disorder, such as ischemic heart disease, tachyarrhythmias or severe heart failure. Caution should be observed when treating patients with a prolonged QTc-interval.
Systemic effects: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
These effects are much less likely to occur with inhaled corticosteroid treatments than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma. Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis. Long-term studies with inhaled budesonide in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density (see Pharmacology: Pharmacodynamics under Actions).
Hypokalaemia and hyperglycaemia: In one clinical trial of 24 weeks that included a 28-week safety extension study, and in one 52-week study evaluating BREZTRI AEROSPHERE in subjects with COPD, there was no evidence of a treatment effect on potassium. Metabolic effects of hyperglycaemia and hypokalaemia may be observed with high doses of β2-adrenergic agonists. The decrease in serum potassium is usually transient, not requiring supplementation (see Interactions).
Anticholinergic activity: Due to its anticholinergic activity, BREZTRI AEROSPHERE should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma.
Renal impairment: Formal pharmacokinetic studies using BREZTRI AEROSPHERE have not been conducted in patients with renal impairment. As glycopyrronium is predominantly renally excreted, patients with severe renal impairment (creatinine clearance of <30 mL/min) should be treated with BREZTRI AEROSPHERE only if the expected benefit outweighs the potential risk.
Hepatic impairment: As budesonide and formoterol are primarily eliminated via hepatic metabolism an increased exposure can be expected in patients with severe hepatic impairment.
In patients with severe hepatic impairment, BREZTRI AEROSPHERE should be used only if the expected benefit outweighs the potential risk (see Pharmacology: Pharmacokinetics under Actions).
Pneumonia: Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections can overlap with the symptoms of COPD exacerbations.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Based on the pharmacological profile, BREZTRI AEROSPHERE is expected to have no or negligible influence on the ability to drive and use machines.