Version July 2025
Chronic obstructive pulmonary disease, maintenance:
Note: Use combination long-acting bronchodilator (long-acting beta agonist and long-acting muscarinic antagonist) in patients with more symptoms (eg, Group B). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Dry powder inhaler (umeclidinium 62.5 mcg/vilanterol 25 mcg per actuation): Oral inhalation: One inhalation once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults. Also see Umeclidinium monograph.
1% to 10%:
Cardiovascular: Chest pain (1%)
Endocrine & metabolic: Diabetes mellitus (≥1%)
Gastrointestinal: Abdominal pain (≥1%), constipation (1%), diarrhea (2%), nausea (≥1%), toothache (≥1%)
Genitourinary: Urinary tract infection (≥1%)
Nervous system: Headache (≥1%), vertigo (≥1%)
Neuromuscular & skeletal: Arthralgia (≥1%), back pain (≥1%), limb pain (2%), muscle spasm (1%), neck pain (1%)
Respiratory: Cough (≥1%), lower respiratory tract infection (1%), pharyngitis (2%), pleuritic chest pain (≥1%), sinusitis (≥1%), viral respiratory tract infection (≥1%)
<1%:
Cardiovascular: Acute myocardial infarction, atrial fibrillation, chest discomfort, supraventricular extrasystole, ventricular premature contractions
Dermatologic: Pruritus, skin rash
Gastrointestinal: Dyspepsia, gastroesophageal reflux disease, vomiting, xerostomia
Nervous system: Asthenia
Neuromuscular & skeletal: Musculoskeletal chest pain
Ophthalmic: Conjunctivitis
Respiratory: Productive cough
Postmarketing:
Cardiovascular: Palpitations
Gastrointestinal: Dysgeusia
Genitourinary: Dysuria, urinary retention
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Nervous system: Anxiety, tremor, voice disorder
Ophthalmic: Blurred vision, eye pain, glaucoma, increased intraocular pressure
Respiratory: Paradoxical bronchospasm
Hypersensitivity to umeclidinium, vilanterol, or any component of the formulation; severe hypersensitivity to milk proteins; monotherapy (without use of a concomitant inhaled corticosteroid) in the treatment of asthma.
Concerns related to adverse effects:
• Asthma-related deaths: Monotherapy with a long-acting beta-2-agonist (LABA) is contraindicated in the treatment of asthma. Umeclidinium/vilanterol is not indicated for the treatment of asthma. Available data do not suggest an increased risk of death with use of LABA in patients with chronic obstructive pulmonary disorder (COPD).
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue use and institute alternative therapy.
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur.
• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (eg, coronary insufficiency, arrhythmias, hypertension); beta-agonists may cause elevation in blood pressure and heart rate. Beta-2 agonists may also produce changes in the ECG (eg, T wave flattening, QTc prolongation, ST segment depression).
• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Glaucoma: Use with caution in patients with narrow-angle glaucoma; may increase intraocular pressure.
• Hyperthyroidism: Use with caution in patients with hyperthyroidism; beta-2 agonists may stimulate thyroid activity.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient).
• Seizures: Use with caution in patients with seizure disorders; beta-2 agonists may result in CNS stimulation/excitation.
• Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction.
Special populations:
• Pediatric: LABAs, when used as monotherapy, may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials in adolescents do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone.
Dosage form specific issues:
• Lactose: Powder for oral inhalation may contain lactose; use is contraindicated in patients with severe milk protein allergy.
Other warnings/precautions:
• Appropriate use: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm or with acutely deteriorating or potentially life-threatening COPD; after initiation of therapy, patients should use short-acting bronchodilators only on an as needed basis for acute symptoms.
Anoro Ellipta contains 30 inhalations (60 blisters) or 7 inhalations (14 blisters) in the institutional pack
Excipient information presented when available (limited, particularly for generics); consult specific product labeling
Aerosol Powder Breath Activated, Inhalation:
Anoro Ellipta: Umeclidinium 62.5 mcg and vilanterol 25 mcg per inhalation (7 dose, 30 dose) [contains milk protein]
No
Aerosol powder (Anoro Ellipta Inhalation)
62.5-25 mcg/ACT (per each): $10.08
Aerosol powder (Umeclidinium-Vilanterol Inhalation)
62.5-25 mcg/ACT (per each): $9.29
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral inhalation: Dry powder inhaler: For oral inhalation only; administer at the same time each day; there is no need to shake the inhaler. Remove inhaler from sealed pouch immediately prior to first use. Each time the cover of the inhaler is opened, a ‘click’ should be heard and the counter will count down by 1 number; dose is ready to be inhaled. If the counter does not count down as the “click” is heard, the inhaler will not deliver the medicine. Only open inhaler cover when ready for administration; opening and closing the device without inhaling will result in a lost dose; do not close inhaler cover until dose has been inhaled. Refer to product labeling for additional administration instructions.
Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Anoro Ellipta may be confused with Arnuity Ellipta, Breo Ellipta, Incruse Ellipta, and Trelegy Ellipta; Ellipta is the inhaler delivery system trademark not a medication.
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Clinically Relevant Anticholinergic Effects: Umeclidinium may increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Atomoxetine: May increase tachycardic effects of Beta2-Agonists. Atomoxetine may increase hypertensive effects of Beta2-Agonists. Risk C: Monitor
Atosiban: Beta2-Agonists may increase adverse/toxic effects of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor
Beta-Blockers (Beta1 Selective): May decrease bronchodilatory effects of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor
Beta-Blockers (Nonselective): May decrease bronchodilatory effects of Beta2-Agonists. Risk X: Avoid
Beta2-Agonists (Long-Acting): May increase adverse/toxic effects of Beta2-Agonists (Long-Acting). Risk X: Avoid
Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification
CYP3A4 Inhibitors (Strong): May increase serum concentration of Vilanterol. Risk C: Monitor
Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor
Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor
Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Inhaled Anticholinergic Agents: May increase anticholinergic effects of Inhaled Anticholinergic Agents. Risk C: Monitor
Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid
Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor
Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification
Loop Diuretics: Beta2-Agonists may increase hypokalemic effects of Loop Diuretics. Risk C: Monitor
Loxapine: Agents to Treat Airway Disease may increase adverse/toxic effects of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid
Methacholine: Beta2-Agonists (Long-Acting) may decrease therapeutic effects of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider Therapy Modification
Methacholine: Long-acting muscarinic antagonists (LAMAs) may decrease therapeutic effects of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Risk D: Consider Therapy Modification
Monoamine Oxidase Inhibitors: May increase adverse/toxic effects of Beta2-Agonists. Risk C: Monitor
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor
Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor
Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor
Theophylline Derivatives: May increase hypokalemic effects of Beta2-Agonists. Beta2-Agonists may increase adverse/toxic effects of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Risk C: Monitor
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Animal reproduction studies have not been conducted with this combination. Beta-agonists have the potential to affect uterine contractility if administered during labor. See individual monographs.
It is not known if sufficient quantities of umeclidinium or vilanterol are absorbed following inhalation to produce detectable amounts in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. See individual monographs.
FEV1, peak flow, and/or other pulmonary function tests; serum potassium, serum glucose; blood pressure, heart rate; CNS stimulation; signs/symptoms of glaucoma; hypersensitivity reactions; urinary retention
Umeclidinium: A long-acting anticholinergic, competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.
Vilanterol: A long-acting beta2-agonist, relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate.
Absorption: Umeclidinium and vilanterol: Systemic, primarily via lungs
Distribution: IV: Umeclidinium: 86 L; Vilanterol: 165 L
Protein binding: Umeclidinium: 89%; Vilanterol: 94%
Metabolism: Hepatic via CYP2D6 (umeclidinium) and CYP3A4 (vilanterol)
Half-life elimination: 11 hours
Excretion: Urine (<1% umeclidinium; 70% vilanterol); feces (92% umeclidinium; 30% vilanterol)
Altered kidney function: Vilanterol systemic exposure (AUC(0-24)) was 56% higher in subjects with severe renal impairment (CrCl <30 mL/minute) compared with healthy subjects.
