References:
חוזר מנכ"ל הרחבת סל שירותי בריאות לשנת 1.2012 2. Onbrez Breezhaler approved prescribing information. 3. Korn S. et al.  Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: A 12-week study. Respiratory Medicine (2011) 105, 719-726. 4. Dahl R. et al. Efficacy of a new once-daily long-acting inhaled b2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010; 65:473-479. 5. Singh et al. Dose delivery characterization of indacaterol following inhalation by COPD patients. Poster presented at ATS 2010. 6. Mahler MA et al.  Combining Once-Daily Bronchodilators In COPD: Indacaterol Plus Tiotropium Versus Tiotropium Alone.. Abstract presented at ATS 2011.
Note: Before prescribing, please consult full prescribing information.
Presentation: Inhalation powder hard capsules containing indacaterol maleate equivalent to
150 microgram (mcg) indacaterol; inhalation powder hard capsules containing indacaterol
maleate equivalent to 300 mcg indacaterol.
Indications: Maintenance of bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Dosage: Adults: The recommended dosage of is the once-daily inhalation of the content of one 150 microgram capsule using the ONBREZ BREEZHALER inhaler. The dosage should only be increased on medical advice. Once-daily inhalation of the content of one 300 microgram capsule, using the ONBREZ BREEZHALER inhaler, has been shown to provide additional clinical benefit to some patients, e.g. with regard to breathlessness, particularly for patients with severe COPD. The maximum dose is 300 microgram once-daily.
Children (<18 years): should not be used in patients under 18 years of age.
Dosing in special populations: No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data is available for subjects with severe hepatic impairment.
Method of administration
ONBREZ BREEZHALER capsules must be administered only by the oral inhalation route and only using the ONBREZ BREEZHALER inhaler. Capsules must not be swallowed. ONBREZ BREEZHALER should be administered at the same time of the day each day. If a dose is missed, the next dose should be taken at the usual time the next day. Capsules must always be stored in the blister, and only removed immediately before used.
Contraindications: Hypersensitivity to the active substance, to lactose or to any of the other excipients.
Precautions/Warnings: ♦ Asthma: should not be used in asthma ♦ Paradoxical bronchospasm: As with other inhalation therapy, administration 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: In case of deterioration of COPD whilst on treatment, a re-evaluation of the patient and the COPD treatment regimen should be undertaken ♦ Systemic effects: 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; in patients who are unusually responsive to beta2-adrenergic agonists
♦ 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, ECG changes ♦ Hypokalaemia: Beta2-adrenergic agonists may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment which may increase the susceptibility to cardiac arrhythmias    ♦ Hyperglycaemia: clinically notable changes in blood glucose and/or serum potassium were generally more frequent by 1 to 2% during clinical studies at the recommended doses than on placebo ♦  should not be used in conjunction with other long-acting beta2-adrenergic agonists or medications containing long-acting beta2-adrenergic agonists ♦ Pregnancy: should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus ♦ Breast-feeding: should only be considered if the expected benefit to the woman is greater than any possible risk to the infant ♦ Fertility: it is considered unlikely that indacaterol will affect reproductive or fertility performance in humans following inhalation of the maximum recommended dose.
Interactions: ♦ should be administered with caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QT interval ♦ concomitant administration of other sympathomimetic agents may potentiate the undesirable effects ♦ concomitant treatment with methylxanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate the possible hypokalaemic effect of beta2- adrenergic agonists ♦ should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use ♦ inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-gp, has no impact on safety of therapeutic doses.
Adverse reactions: ♦ Common (1 to 10%): nasopharyngitis, upper respiratory tract infection, cough, muscle spasm, oropharyngeal pain, sinusitis, myalgia, peripheral oedema, ischaemic heart disease, diabetes mellitus and hyperglycaemia, dry mouth, rhinorrhoea, musculoskeletal pain, chest pain. ♦ Uncommon (0.1 to 1%): atrial fibrillation, chest discomfort, vertigo, paresthesia.
Packs: Onbrez Breezhaler 150, 300 microgram is supplied as packs containing 30 hard capsules plus inhaler device.
NSS 04.2011         Based on ONB API DEC10 CL V1