Onbrez Breezhaler Special Precautions

Asthma: Onbrez Breezhaler should not be used in asthma due to the absence of long-term outcome data in asthma with Onbrez Breezhaler.
Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Hypersensitivity: Immediate hypersensitivity reactions have been reported after administration of Onbrez Breezhaler. If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Onbrez Breezhaler should be discontinued immediately and alternative therapy instituted.
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 initial treatment of acute episodes of bronchospasm, i.e., as a rescue therapy. In case of deterioration of 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 beta₂-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 beta₂-adrenergic agonists.
As with other inhaled beta₂-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 beta₂-adrenergic agonists or medications containing long-acting beta₂-adrenergic agonists.
Onbrez Breezhaler contains lactose.
Cardiovascular effects: Like other beta₂-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, the drug may need to be discontinued. In addition, beta₂-adrenergic agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of QT interval, and ST segment depression, although the clinical significance of these findings is unknown. Therefore, long-acting beta₂-adrenergic agonists (LABA) or LABA containing products such as Onbrez Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or patients treated with medicinal products affecting the QT interval.
Hypokalemia: Beta₂-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, hypokalemia may be potentiated by hypoxia and concomitant treatment (see INTERACTIONS) which may increase the susceptibility to cardiac arrhythmias.
Hyperglycemia: Inhalation of high doses of beta₂-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% in patients on Onbrez Breezhaler at the recommended doses than in patients on placebo. Onbrez Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.