Vilanterol, Umeclidinium Bromide

Pharmacologic Category

Anticholinergic Agent; Anticholinergic Agent, Long-Acting; Beta2 Agonist; Beta2-Adrenergic Agonist, Long-Acting

Dosing: Adult

COPD: Oral inhalation: Dry powder inhaler: One inhalation (umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily; maximum dose: 1 inhalation/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

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).

Use: Labeled Indications

Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Comparative Efficacy

• UMECLIDINIUM/VIANTEROL

Clinical Practice Guidelines

Asthma:

Global Strategy for Asthma Management and Prevention (GINA), 2018 Update

NHLBI and NAEPP The Expert Panel Report 3: “Guidelines for the Diagnosis and Management of Asthma,” Full Report 2007

COPD:

GOLD 2018 Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, 2018

Administration: 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.

Storage/Stability

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.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat COPD (chronic obstructive pulmonary disease).

• This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

Frequently reported side effects of this drug

• Sore throat

• Stuffy nose

• Common cold symptoms

• Muscle spasms

• Painful extremities

• Constipation

• Diarrhea

• Neck pain

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• High blood sugar like confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit.

• Low potassium like muscle pain or weakness, muscle cramps, or an abnormal heartbeat.

• Chest pain

• Fast heartbeat

• Abnormal heartbeat

• Severe anxiety

• Severe headache

• Severe dizziness

• Passing out

• Tremors

• Severe nausea

• Vomiting

• Vision changes

• Eye pain

• Severe eye irritation

• Seeing halos around lights

• Red eyes

• Difficult urination

• Change in amount of urine passed

• Painful urination

• Passing a lot of urine

• Difficulty breathing

• Wheezing

• Cough

• Signs of a significant reaction like 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. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound alike/look alike issues:

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s005lbl.pdf#page=27, must be dispensed with this medication.

Contraindications

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.

Warnings/Precautions

Concerns related to adverse effects:

• Asthma-related deaths: Monotherapy with a long-acting beta-2-agonist (LABA) is contraindicated in the treatment of asthma. In a large, randomized, placebo-controlled US clinical trial (SMART [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. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone. 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). 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.

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.

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.

Pregnancy Risk Factor

C

Pregnancy Considerations

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.

Breast-Feeding Considerations

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.

Adverse Reactions

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

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions Open Interactions

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Anticholinergic Agents: Umeclidinium may enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Risk C: 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. Risk C: Monitor therapy

Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Risk X: 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. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Risk C: Monitor therapy

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Risk C: Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: 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. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): Vilanterol may increase the serum concentration of CYP3A4 Inhibitors (Strong). Risk C: Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: 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. Risk D: Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: 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. Risk X: Avoid combination

Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect 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 diminish the therapeutic effect of Methacholine. Risk D: Consider therapy modification

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: 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. Risk C: 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. Risk C: Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Risk D: Consider therapy modification

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. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination

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. Risk C: Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: 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. Risk D: Consider therapy modification

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Monitoring Parameters

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

Advanced Practitioners Physical Assessment/Monitoring

Obtain FEV1, peak flow, and/or other pulmonary function tests. Obtain blood pressure and heart rate. Assess for CNS stimulation and ocular changes.

Nursing Physical Assessment/Monitoring

Check ordered pulmonary tests and report abnormalities. Monitor blood pressure and heart rate. Monitor for signs of bronchospasm. Instruct patient on proper administration.

Dosage Forms Considerations

Anoro Ellipta contains 30 inhalations (60 blisters) or 7 inhalations (14 blisters) in the institutional pack

Dosage Forms: US

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]

Anatomic Therapeutic Chemical (ATC) Classification

• R03AL03

Generic Available (US)

No

Pricing: US

Aerosol powder (Anoro Ellipta Inhalation)

62.5-25 mcg/INH (per each): $8.69

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.

Mechanism of Action

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.

Pharmacodynamics/Kinetics

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)

Pharmacodynamics/Kinetics: Additional Considerations

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.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Umeclidinium Brm/Vilanterol Tr; Umeclidinium Bromide and Vilanterol; Vilanterol and Umeclidinium

FDA Approval Date

December 18, 2013

References

Anoro Ellipta (umeclidinium/vilanterol) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; July 2019.

Anoro Ellipta (umeclidinium/vilanterol) [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline Inc; August 2017.

Global Initiative for Asthma (GINA). GINA report, Global Strategy for Asthma Management and Prevention. https://ginasthma.org/2018-gina-report-global-strategy-for-asthma-management-and-prevention/. Updated 2018. Accessed September 30, 2018.

Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26.[PubMed 16424409]

Peters SP, Bleecker ER, Canonica GW, et al. Serious asthma events with budesonide plus formoterol vs. budesonide alone. N Engl J Med. 2016;375(9):850-860. doi: 10.1056/NEJMoa1511190.[PubMed 27579635]

Stempel DA, Raphiou IH, Kral KM, et al; AUSTRI Investigators. Serious asthma events with fluticasone plus salmeterol versus fluticasone alone. N Engl J Med. 2016a;374(19):1822-1830. doi: 10.1056/NEJMoa1511049.[PubMed 26949137]

Stempel DA, Szefler SJ, Pedersen S, et al; VESTRI Investigators. Safety of adding salmeterol to fluticasone propionate in children with asthma. N Engl J Med. 2016b;375(9):840-849. doi: 10.1056/NEJMoa1606356.[PubMed 27579634]

US Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf. Published August 28, 2007.

Brand Names: International

Anoro (AT, BE, CY, CZ, DE, DK, EE, EG, ES, HR, HU, IE, IS, KR, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK); Anoro Ellipta (AU, BB, BH, CH, GB, HK, IL, JP, KW, LB, MY, PH, SG); Laventair (IE, MT, PT)

Last Updated 4/8/20