Umeclidinium and Vilanterol
Medically reviewed on Jan 3, 2019
(ue me kli DIN ee um & VYE lan ter ol)
- Umeclidinium Brm/Vilanterol Tr
- Umeclidinium Bromide and Vilanterol
- Vilanterol and Umeclidinium
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]
Brand Names: U.S.
- Anoro Ellipta
- Anticholinergic Agent
- Anticholinergic Agent, Long-Acting
- Beta2 Agonist
- Beta2-Adrenergic Agonist, Long-Acting
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.
Umeclidinium and vilanterol: Systemic, primarily via lungs
IV: Umeclidinium: 86 L; Vilanterol: 165 L
Hepatic via CYP2D6 (umeclidinium) and CYP3A4 (vilanterol)
Urine (<1% umeclidinium; 70% vilanterol); feces (92% umeclidinium; 30% vilanterol)
Umeclidinium: 89%; Vilanterol: 94%
Special Populations: Renal Function Impairment
Vilanterol systemic exposure (AUC(0-24)) was 56% higher in subjects with severe renal impairment (CrCl <30 mL/minute) compared with healthy subjects.
Use: Labeled Indications
COPD: Maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema
Hypersensitivity to umeclidinium, vilanterol, or any component of the formulation; severe hypersensitivity to milk proteins
Canadian labeling: Additional contraindications (not in US labeling): Patients with asthma without use of long-term asthma control medication
COPD: Oral inhalation: Dry powder inhaler: One inhalation (umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily; maximum dose: 1 inhalation/day
Refer to adult dosing.
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.
Store between 68°F and 77°F (20°C and 25°C); excursions are permitted between 59°F and 86°F (15°C and 30°C). Store in a dry place away from direct heat or sunlight. Store inside the original, unopened foil tray; remove from tray immediately prior to initial use. Discard inhaler 6 weeks after opening the foil tray or after the labeled number of inhalations have reached zero, whichever comes first.
Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Anticholinergic Agents: Umeclidinium may enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy
Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Avoid combination
Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy
Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination
Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
Cocaine (Topical): May enhance the hypertensive effect 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. Consider therapy modification
CYP3A4 Inhibitors (Strong): Vilanterol may increase the serum concentration of CYP3A4 Inhibitors (Strong). Monitor therapy
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect 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. Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Monitor therapy
Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect 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. Monitor therapy
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Avoid combination
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Consider therapy modification
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Also see umeclidinium monograph for additional reactions.
1% to 10%:
Cardiovascular: Chest pain (1%)
Central nervous system: Headache (≥1%), vertigo (≥1%)
Endocrine & metabolic: Diabetes mellitus (≥1%)
Gastrointestinal: Diarrhea (2%), abdominal pain (≥1%), nausea (≥1%), toothache (≥1%), constipation (1%)
Genitourinary: Urinary tract infection (≥1%)
Neuromuscular & skeletal: Limb pain (2%), arthralgia (≥1%), back pain (≥1%), muscle spasm (1%), neck pain (1%)
Respiratory: Pharyngitis (2%), cough (≥1%), lower respiratory tract infection (≥1%), pleuritic chest pain (≥1%), sinusitis (≥1%)
<1%, postmarketing, and/or case reports: Atrial fibrillation, anxiety, blurred vision, chest discomfort, conjunctivitis, dysgeusia, dyspepsia, dysuria, gastroesophageal reflux disease, glaucoma, hypersensitivity reaction (including anaphylaxis, angioedema and urticaria), increased intraocular pressure, musculoskeletal chest pain, myocardial infarction, palpitations, paradoxical bronchospasm, pruritus, skin rash, supraventricular extrasystole, urinary retention, tremor, ventricular premature contractions, voice disorder, vomiting, weakness, xerostomia
Concerns related to adverse effects:
• Asthma-related deaths: [US Boxed Warning]: Long-acting beta-2 adrenergic agonists (LABAs), such as vilanterol, increase the risk of asthma-related death. The safety and efficacy of umeclidinium/vilanterol in patients with asthma have not been established. Umeclidinium/vilanterol is not indicated for the treatment of asthma. In a large, randomized, placebo-controlled US clinical trial (Nelson 2006), salmeterol was associated with an increase in asthma-related deaths (when added to usual asthma therapy); risk is considered a class effect among all LABAs. Data are not available to determine if the addition of an inhaled corticosteroid lessens this increased risk of death associated with LABA use; however, current guidelines recommend the use of an inhaled corticosteroid before adding a LABA (GINA 2018; NIH/NHLBI 2007). In a more recent multicenter, randomized, double-blinded trial, the use of salmeterol and an inhaled corticosteroid (ie, fluticasone) combined in a single inhaler in a large number of children, adolescent, and adult patients with persistent asthma (non-life threatening and stable) did not increase the risk of serious asthma-related events compared with fluticasone alone; in addition, patients receiving fluticasone/salmeterol had fewer severe asthma exacerbations compared with patients receiving fluticasone alone (Peters 2016; Stempel 2016a; Stempel 2016b). A similar increase in the risk of death associated with LABAs has not been demonstrated in patients with COPD.
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled 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.
• 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; the effect is usually transient.
• 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; the effect is usually transient.
• Seizure disorders: 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.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
• Lactose: Powder for oral inhalation may contain lactose; use is contraindicated in patients with severe milk protein allergy.
• 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.
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
Pregnancy Risk Factor
Animal reproduction studies have not been conducted with this combination. Beta-agonists have the potential to affect uterine contractility if administered during labor.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience pharyngitis, rhinorrhea, muscle spasms, painful extremities, constipation, diarrhea, or neck pain. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), angina, tachycardia, arrhythmia, severe anxiety, severe headache, severe dizziness, tremors, severe nausea, vomiting, vision changes, eye pain, severe eye irritation, visual halos around lights, urinary retention, change in amount of urine passed, pain with urination, difficulty breathing, wheezing, or cough (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about umeclidinium/vilanterol
- Umeclidinium/vilanterol Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 35 Reviews
- Drug class: bronchodilator combinations
Other brands: Anoro Ellipta