Novartis announced that FDA has approved its new combo inhaler, Utibron Neohaler, for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The FDA also approved the company’s Seebri Neohaler, a single-agent COPD inhaler.

Indications: 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 COPD. It is not indicated for the relief or acute bronchospasm or for the treatment of asthma.

Dosing/Administration: Utibron capsules should only be used with the Neohaler device. For the maintenance treatment of COPD, the inhalation of the powder contents of one Utibron capsule should be taken twice daily. Capsules contain 27.5 mcg of indacaterol and 15.6 mcg of glycopyrrolate inhalation powder for use with the Neohaler device.

Warnings/Precautions: Do not initiate in acutely deteriorating COPD or to treat acute symptoms. Do not use in combination with an additional medicine containing LABA because of risk of overdose. If paradoxical bronchospasm occurs, discontinue Utibron Neohaler immediately and institute alternative therapy. Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, sensitivity to sympathomimetic drugs, diabetes mellitus, and ketoacidosis.

Side Effects/Risks: The most common adverse reactions (incidence ≥2% and higher than placebo) are nasopharyngitis and hypertension. The safety and efficacy of Utibron Neohaler in patients with asthma have not been established.

Citation: FDA approves new Novartis dual combination bronchodilator Utibron Neohaler for patients with chronic obstructive pulmonary disease. [news release]. East Hanover, NJ: Novartis; October 29, 2015: Full prescribing information available at http://www.pharma.us.novartis.com/product/pi/pdf/utibron.pdf.

Accessed November 3, 2015.