| WARNING: ASTHMA-RELATED DEATH
See full prescribing information for complete boxed warning.
Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in ANORO ELLIPTA, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABA, including vilanterol.
The safety and efficacy of ANORO ELLIPTA in patients with asthma have not been established. ANORO ELLIPTA is not indicated for the treatment of asthma.
See addtional warnings and precautions below.
| ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder)
FOR ORAL INHALATION USE
Initial U.S. Approval: 2013
ANORO ELLIPTA is an inhalation powder drug product for delivery of a combination of umeclidinium (an anticholinergic) and vilanterol (a LABA) to patients by oral inhalation.
| Mechanism of Action:
ANORO ELLIPTA: ANORO ELLIPTA contains both umeclidinium and vilanterol. The mechanisms of action described below for the individual components apply to ANORO ELLIPTA. These drugs represent 2 different classes of medications (an anticholinergic and a LABA) that have different effects on clinical and physiological indices.
Umeclidinium: Umeclidinium is a long-acting, antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of umeclidinium is predominantly a site-specific effect.
Vilanterol: Vilanterol is a LABA. In vitro tests have shown the functional selectivity of vilanterol was similar to salmeterol. The clinical relevance of this in vitro finding is unknown.
Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, there are also beta2-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects.
The pharmacologic effects of beta2-adrenergic agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
| INDICATIONS AND USAGE:
ANORO ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Important limitations: Not indicated for the relief of acute bronchospasm or for the treatment of asthma.
| WARNINGS AND PRECAUTIONS:
| ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥1% and more common than placebo) include pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
| DOSAGE AND ADMINISTRATION:
For oral inhalation only.
Maintenance treatment of COPD: 1 inhalation of ANORO ELLIPTA once daily.
ANORO ELLIPTA should be taken at the same time every day. Do not use ANORO ELLIPTA more than 1 time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment
| DOSAGE FORMS AND STRENGTHS:
Inhalation Powder. Inhaler containing 2 double-foil blister strips of powder formulation for oral inhalation. One strip contains umeclidinium 62.5 mcg per blister and the other contains vilanterol 25 mcg per blister.
| Package insert data: [Accessed: Jan 2014]
ANORO and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.
PRINCIPAL DISPLAY PANEL
Initial U.S. Approval: 2013
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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