Asthma: Onbrez Breezhaler should not be used in asthma due to the absence of long-term outcome data in asthma.
Paradoxical Bronchospasm: As with other inhalation therapy, administration of Onbrez Breezhaler may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, Onbrez Breezhaler should be discontinued immediately and alternative therapy instituted.
Deterioration of Disease: Onbrez Breezhaler is not indicated for the treatment of acute episodes of bronchospasm ie, as a rescue therapy. In case of deterioration of chronic obstructive pulmonary disease (COPD) whilst on treatment with Onbrez Breezhaler, a re-evaluation of the patient and the COPD treatment regimen should be undertaken. An increase in the daily dose of Onbrez Breezhaler beyond the maximum dose is not appropriate.
Systemic Effects: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez Breezhaler at the recommended doses, as with other β2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to β2-adrenergic agonists.
As with other inhaled β2-adrenergic drugs, Onbrez Breezhaler should not be used more often or at higher doses than recommended.
Onbrez Breezhaler should not be used in conjunction with other long-acting β2-adrenergic agonists or medications containing long-acting β2-adrenergic agonists.
Cardiovascular Effects: Like other β2-adrenergic agonists, indacaterol may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur, Onbrez Breezhaler may need to be discontinued. In addition, β-adrenergic agonists have been reported to produce electrocardiogram changes eg, flattening of the T-wave and ST-segment depression, although the clinical significance of these findings is unknown.
Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Onbrez Breezhaler at recommended therapeutic doses (see Pharmacology under Actions).
Hypokalaemia: β2-adrenergic agonists may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see Interactions) which may increase the susceptibility to cardiac arrhythmias.
Hyperglycaemia: Inhalation of high doses of β2-adrenergic agonists may produce increases in plasma glucose. Upon initiation of treatment with Onbrez Breezhaler, plasma glucose should be monitored more closely in diabetic patients.
During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Onbrez Breezhaler at the recommended doses than on placebo. This product has not been investigated in patients with not well-controlled diabetes mellitus.
Effects on the Ability to Drive or Operate Machinery: Onbrez Breezhaler has no or negligible influence on the ability to drive and use machines.
Labour and Delivery: Like other β2-adrenergic agonists, Onbrez Breezhaler may inhibit labor due to a relaxant effect on uterine smooth muscle.
Fertility: Reproduction studies or other data in animals did not reveal a problem or potential problem concerning fertility in either males or females.
Use in pregnancy & lactation: No clinical data on exposed pregnancies in COPD patients are available. Studies in animals have shown reproductive toxicity associated with an increased incidence of 1 skeletal variation in rabbits (see Nonclinical Safety Data under Actions). The potential risk for humans is unknown. Because there are no adequate and well-controlled studies in pregnant women, indacaterol should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.
It is not known whether indacaterol passes into human breast milk. The substance has been detected in the milk of lactating rats. Because many drugs are excreted in human milk, as with other inhaled β2-adrenergic drugs, the use of Onbrez Breezhaler by breastfeeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.