Umeclidinium and Vilanterol
(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
Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Limitations of use: Not for the relief of acute bronchospasm or for asthma treatment
Hypersensitivity to umeclidinium, vilanterol, or any component of the formulation; severe hypersensitivity to milk proteins
Chronic obstructive pulmonary disease (COPD): Umeclidinium 62.5 mcg/vilanterol 25 mcg: One inhalation once daily; maximum dose: 1 inhalation/day
Refer to adult dosing.
Dosing: Renal Impairment
No dosage adjustment necessary.
Dosing: Hepatic Impairment
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).
Oral inhalation: Administer at the same time each day. After removing from foil tray, write the “Tray Opened” and “Discard” dates on the inhaler label. Discard device 6 weeks after it is removed from the foil tray or when the dose counter reads “0” (whichever comes first).
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.
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
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
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. 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
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
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: 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
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. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination
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
Long-Acting Beta2-Agonists: May enhance the adverse/toxic effect of other Long-Acting Beta2-Agonists. Avoid combination
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
MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. 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. Avoid combination
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. 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
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to 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
Percentages as reported with combination product.
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% (Limited to important or life-threatening): Atrial fibrillation, anxiety, conjunctivitis, dysgeusia, dyspepsia, gastroesophageal reflux disease, hypersensitivity reaction (including anaphylaxis, angioedema, urticaria), musculoskeletal chest pain, myocardial infarction, palpitations, pruritus, skin rash, supraventricular extrasystole, tremor, ventricular premature contractions
Concerns related to adverse effects:
• Asthma-related deaths: [US Boxed Warning]: Long-acting beta2-adrenergic agonists (LABAs) such as vilanterol increase the risk of asthma-related death. 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 2015; 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. Not indicated for treatment of asthma.
• Bronchospasm: Can produce paradoxical bronchospasm, which may be life threatening; discontinue use immediately and institute alternative therapy.
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria may occur; discontinue if such reactions occur. Use is contraindicated in patients with severe milk protein allergy.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease, especially coronary insufficiency, cardiac arrhythmias, and hypertension; beta-agonists may cause elevation in blood pressure, heart rate, and increase risk of arrhythmias; may also cause electrocardiogram (ECG) changes (eg, flattening of the T wave, QTc prolongation, ST segment depression).
• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Glaucoma: Use with caution in patients with narrow-angle glaucoma; monitor for symptoms of acute narrow-angle glaucoma, including eye pain/discomfort, blurred vision, visual halos, or colored images.
• Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium.
• Prostatic hyperplasia/bladder neck obstruction: Umeclidinium may worsen the symptoms of prostatic hyperplasia and/or bladder neck obstruction (eg, painful urination, difficulty passing urine); use with caution.
• Seizure disorders: Use with caution in patients with seizure disorders; beta2-agonists may result in CNS stimulation/excitation.
• Thyrotoxicosis: Use with caution in patients with thyrotoxicosis; beta-agonists may exacerbate the condition.
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 contains lactose; use is contraindicated in patients with severe milk protein allergy.
• Appropriate use: Do not use for acute episodes of COPD. Do not initiate in patients with significantly worsening, potentially life-threatening, or acutely deteriorating COPD. Do not exceed the recommended dose. Do not use with other long-acting beta2-agonists; clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
• Patient information: Patients must be instructed to use short-acting beta2-agonist (eg, albuterol) for acute COPD symptoms and to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of inhaled short-acting beta2-agonist may indicate deterioration of COPD, and medical evaluation to assess treatment regimen must not be delayed.
FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; ocular changes
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.
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Other brands: Anoro Ellipta