Utibron Neohaler

Pharmacy TimesApril 2016 Respiratory Health
Volume 82
Issue 4

The FDA has approved Utibron Neohaler oral inhalation powder for long-term maintenance treatment of airflow obstruction in patients with COPD.

The FDA has approved Utibron Neohaler (indacaterol and glycopyrrolate) oral inhalation powder for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The approval carries the limitation that Utibron Neohaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma.1 An estimated 27 million Americans are affected by COPD; it is the third leading cause of death in the United States and a significant cause of long-term disability.2

Pharmacology and Pharmacokinetics

Indacaterol is a long-acting beta2- adrenergic agonist (LABA). Upon inhalation, indacaterol causes bronchodilation by relaxing the bronchial smooth muscle. Glycopyrrolate is a long-acting anticholinergic that inhibits the M3 receptors in smooth muscle, leading to bronchodilation.1 After inhalation of Utibron Neohaler, the median time to reach peak plasma concentration is 15 minutes for indacaterol and 5 minutes for glycopyrrolate. Age, weight, gender, smoking status, and baseline forced expiratory volume in 1 second (FEV1) did not affect the pharmacokinetics of Utibron Neohaler.1

Dosage and Administration

Utibron is supplied as capsules containing 27.5 mcg of indacaterol and 15.6 mcg of glycopyrrolate inhalation powder. The capsules should remain in their blister pack until immediately prior to use. The contents of 1 Utibron capsule should be inhaled with the Neohaler device twice daily at the same time each day. The capsules are for oral inhalation only and should never be swallowed.1

Clinical Trials

The efficacy of Utibron Neohaler was evaluated in two 12-week, randomized, double-blinded, placebo- and active-controlled, parallelgroup trials of 2038 patients with COPD. Patients received Utibron Neohaler, one of its individual components (indacaterol or glycopyrrolate), or placebo. At each study’s end, the Utibron-Neohaler arm demonstrated a greater increase in mean change from baseline FEV1 than the other arms of the study. Patients using Utibron Neohaler also required fewer doses of rescue medication than the patients using placebo.

A 12-month, randomized, double- blind, active-controlled trial of 615 patients evaluated the role of Utibron Neohaler’s bronchodilation and its effects on long-term safety. At year-end, Utibron Neohaler demonstrated a significant treatment effect, with an increase in predose trough FEV1 compared with indacaterol once-daily alone.1

Contraindications, Warnings, and Precautions

Utibron Neohaler carries a boxed warning stating that LABAs such as indacaterol may increase the risk of asthma-related death. The warning also states that Utibron Neohaler has not been studied in patients with asthma and is not indicated for the treatment of asthma. Utibron Neohaler is also contraindicated in patients with a known hypersensitivity to indacaterol, glycopyrrolate, or any of the components.

Treatment with Utibron Neohaler should not be initiated in patients with acutely deteriorating COPD or for acute symptoms. It should not be used in combination with an additional medication that contains an LABA. If paradoxical bronchospasm occurs, Utibron Neohaler should be discontinued immediately. Utibron Neohaler should be used cautiously in patients with cardiovascular or convulsive disorder, thyrotoxicosis, sensitivity to sympathomimetic medications, diabetes, and ketoacidosis. Worsening of narrowangle glaucoma or urinary retention may occur during treatment. Beta2-adrenergic agents may cause hypokalemia or hyperglycemia.

Concomitant use with other adrenergic drugs may potentiate the sympathetic effects of indacaterol. Use with xanthine derivatives, steroids, diuretics, or nonpotassium- sparing diuretics may potentiate hypokalemia or changes on an electrocardiogram. Use with monoamine oxidase inhibitors, tricyclic antidepressants, and drugs that prolong the QTc interval may potentiate effect on the cardiovascular system. Use with beta-blockers may decrease the effectiveness of Utibron Neohaler. Concurrent use with anticholinergic medications should be avoided as the combination may interact additively. The most common adverse effects (≥2% and higher than placebo) were nasopharyngitis and hypertension.1

Monica Holmberg, PharmD, BCPS Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.


  • Utibron Neohaler complete prescribing information. Available at http://www.pharma.us.novartis.com/product/pi/pdf/utibron.pdf Accessed February 2016.
  • FDA approves new Novartis dual combination bronchodilator Utibron Neohaler for patients with chronic obstructive pulmonary disease. Available at http://www.prnewswire.com/news-releases/fda-approves-new-novartis-dual-combination-bronchodilator-utibron-neohaler-for-patients-with-chronic-obstructive-pulmonary-disease-300169137.html Accessed February 2016.

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