UTIBRON NEOHALER is a combination of indacaterol, a long-acting beta2-adrenergic agonist (LABA), and glycopyrrolate, an anticholinergic, indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (1)

Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1, 5.1, 5.2)

• For oral inhalation only. Do not swallow UTIBRON capsules. Only use UTIBRON capsules with the NEOHALER device. (2)
• Maintenance treatment of COPD: The inhalation of the powder contents of one UTIBRON capsule twice-daily (2)

• Inhalation powder: UTIBRON capsules contain 27.5 mcg of indacaterol and 15.6 mcg glycopyrrolate inhalation powder for use with the NEOHALER device (3)

• All LABAs are contraindicated in patients with asthma without use of a long-term asthma controller medication. (4) UTIBRON NEOHALER is not indicated for the treatment of asthma. (1)
• History of known hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients. (4, 5.5)

• Do not initiate in acutely deteriorating COPD or to treat acute symptoms. (5.2)
• Do not use in combination with an additional medicine containing LABA because of risk of overdose. (5.3, 7.1)
• If paradoxical bronchospasm occurs, discontinue UTIBRON NEOHALER immediately and institute alternative therapy. (5.4)
• Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, sensitivity to sympathomimetic drugs, diabetes mellitus, and ketoacidosis. (5.6, 5.7, 7.1)
• Worsening of narrow-angle glaucoma or urinary retention may occur. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur. (5.8, 5.9)
• Be alert to hypokalemia and hyperglycemia. (5.10)

Most common adverse reactions (incidence ≥2% and higher than placebo) are nasopharyngitis and hypertension. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Other adrenergic drugs may potentiate effect: Use with caution (5.3, 7.1)
• Xanthine derivatives, steroids, diuretics or non-potassium-sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. (7.2, 7.3)
• Monoamine Oxidase inhibitors, tricyclic antidepressants, and drugs that prolong QTc interval may potentiate effect on cardiovascular system. Use with extreme caution. (7.4)
• Beta-blockers may decrease effectiveness: Use with caution and only when medically necessary. (7.5)
• Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of UTIBRON NEOHALER with other anticholinergic-containing drugs. (7.6)

• Use in patients with severe renal impairment should be considered if the potential benefit of the treatment outweighs the risk. (8.6)