UTIBRON NEOHALER(Indacaterol and Glycopyrrolate Inhalation Powder, for Oral Inhalation Use)
UTIBRON NEOHALER Rx
Pharmacological Class:
Long-acting beta2-agonist (LABA) + anticholinergic.
Active Ingredient(s):
Indacaterol 27.5mcg, glycopyrrolate 15.6mcg; per capsule; dry powder for oral inhalation for use with Neohaler device; contains lactose.
Company
Novartis Pharmaceuticals Corp
Indication(s):
Long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. Limitations of use: not for the relief of acute bronchospasm or for the treatment of asthma.
Pharmacology:
Indacaterol, a LABA, stimulates intracellular adenyl cyclase for the conversion of ATP to cyclic AMP, increasing its levels which then causes bronchial smooth muscle relaxation and inhibition of release of mediators of immediate hypersensitivity from mast cells.
Glycopyrrolate, a long-acting muscarinic antagonist (anticholinergic), inhibits M3 receptor at the smooth muscle in the airways leading to bronchodilation.
Clinical Trials:
The safety and efficacy of Utibron Neohaler were eva luated in 3 dose-ranging trials, two 12-week (placebo- and active-controlled) lung function trials, and a 12-month long-term safety trial.
Results from the individual components' dose-ranging trials supported the eva luation of indacaterol 27.5mcg twice daily (BID) and glycopyrrolate 15.6mcg BID in the confirmatory COPD trials.
The confirmatory trials (Trials 1 and 2), eva luated Utibron Neohaler in 2,038 COPD subjects. The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Day 85 compared to placebo, glycopyrrolate 15.6mcg BID and indacaterol 27.5mcg BID. In both trials, Utibron Neohaler demonstrated a larger increase in mean change from baseline in FEV1 AUC0-12h compared to placebo, indacaterol, and glycopyrrolate (Trial 1: 0.262L (0.224, 0.300), 0.112L (0.075, 0.149), 0.079L (0.042, 0.116); Trial 2: 0.231L (0.192, 0.271), 0.094L (0.055, 0.133), 0.098L (0.059, 0.137), respectively).
For more clinical trial data, see full labeling.
Legal Classification:
Rx
Adults:
For oral inhalation use only with Neohaler device; do not swallow caps. Administer at the same time of the day (AM + PM). Inhale contents of one capsule (27.5mcg/15.6mcg) twice daily.
Children:
Not established.
Contraindication(s):
LABA use in asthma patients without use of long-term control medication.
Warnings/Precautions:
LABAs increase risk of asthma-related death. Not recommended for treating asthma. Do not initiate in patients during acutely deteriorating or potentially life-threatening COPD episodes. Not for treating acute symptoms. Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Discontinue immediately and treat if paradoxical bronchospasm or immediate hypersensitivity reactions occur; use alternative therapy. Severe milk protein hypersensitivity. Cardiovascular disorders (eg, coronary insufficiency, cardiac arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Hypokalemia. Hyperglycemia. Severe renal impairment or ESRD requiring dialysis. Severe hepatic impairment: not studied. Pregnancy (Category C). Labor & delivery. Nursing mothers: not recommended.
Interaction(s)
Caution with concomitant other adrenergic drugs; may potentiate sympathetic effects. Concomitant xanthine derivatives, steroids, or diuretics may potentiate hypokalemia. Caution with non-K+-sparing diuretics. Extreme caution with MAOIs, tricyclics, or others that prolong QTc interval. Antagonized by β-blockers; if needed, use cardioselective agents if no acceptable alternatives. Additive effects with concomitant other anticholinergic-containing drugs; avoid.
Adverse Reaction(s)
Nasopharyngitis, hypertension, back pain, oropharyngeal pain; paradoxical bronchospasm, hypersensitivity reactions.
How Supplied:
Blister pack—6, 60 (w. one Neohaler device)
LAST UPDATED:
2/8/2016
