• Maintenance treatment of COPD.

Contraindicated in:

• Severe hypersensitivity to milk proteins or other ingredients
• Acutely deteriorating COPD or acute respiratory symptoms
• Asthma
• Concurrent use with other anticholinergics.

Use Cautiously in:

• Concurrent use with strong inhibitors of CYP3A4 (↑ risk of cardiovascular adverse reactions)
• Narrow-angle glaucoma (may cause acute angle closure)
• History of seizures
• Thyrotoxicosis
• History of cardiovascular disorders (coronary insufficiency, arrhythmias, hypertension
• Urinary retention, prostatic hyperplasia, bladder-neck obstruction)
• Severe hepatic impairment
• OB: Use only if potential maternal benefit justifies potential fetal risk; may interfere with uterine contractility during labor
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established
• Geri: Elderly patients may be more sensitive to drug effects.

Exercise Extreme Caution in:

• Concurrent use with MAO inhibitors or tricyclic antidepressants (↑ risk of adverse cardiovascular reactions from vilanterol).

Combination

CV: chest pain, pleuritic pain.

EENT: pharyngitis.

GI: abdominal pain, nausea.

MS: arthralgia, back pain, extremity pain, muscle spasms, neck pain.

Neuro: headache, vertigo.

Resp: cough, sinusitis.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), tooth pain.

Umeclidinium

CV: chest pain.

EENT: acute narrow-angle glaucoma.

GU: urinary retention.

Resp: PARADOXICAL BRONCHOSPASM.

Vilanterol

CV: arrhythmias, ECG changes, hypertension.

Endo: hyperglycemia.

F and E: hypokalemia.

Drug-Drug:

• ↑ risk of adverse anticholinergic adverse reactions when used concurrently with other anticholinergics (avoid concurrent use).
• Concurrent use with MAOIs or tricyclic antidepressants ↑ risk of adverse cardiovascular reactions from vilanterol (use with extreme caution).
• Concurrent use with strong CYP3A4 inhibitors including ketoconazole may ↑ risk of adverse cardiovascular effects (use cautiously).
• Concurrent use with non-potassium sparing diuretics may ↑ risk of hypokalemia and adverse cardiovascular reactions (use cautiously).
• Concurrent use with beta blockers may ↓ effectiveness and cause severe bronchospasm (use cautiously).
• Should not be used concurrently with any other long-acting beta₂-adrenergic blockers.

• Inhalation powder (contains lactose): umeclidinium 62.5 mcg/vilanterol 25 mcg in a two-strip blister per dose;

• Inhaln (Adults): One inhalation (umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily.

Anoro Ellipta

• Umeclidinium: acts as an anticholinergic by inhibiting M3 muscarinic receptors in bronchial smooth muscle resulting in bronchodilation; vilanterol: a beta₂-adrenergic agonist stimulates adenyl cyclase, resulting in accumulation of cyclic adenosine monophosphate at beta₂—adrenergic receptors resulting in bronchodilation.

• Bronchodilation with decreased airflow obstruction.

Therapeutic Classification: bronchodilators

Pharmacologic Classification: anticholinergics, adrenergics, long-acting beta2-adrenergic agonists (LABAs)

Absorption: Umeclidinium: minimal oral absorption; remainder of absorption occurs in lungs; vilanterol: minimal oral absorption; remainder of absorption occurs in lungs. Total amount of systemic absorption of both drugs is small.

Distribution: Unknown.

Metabolism/Excretion: Umeclidinium: primarily metabolized by CYP2D6, metabolites do not contribute to bronchodilation; vilanterol: primarily metabolized by CYP3A4, metabolites do not contribute to bronchodilation.

Half-life: Umeclidinium: 11 hr; vilanterol: 11 hr.

(bronchodilation)

• Instruct patient in proper use of inhaler and to take medication at the same time each day as directed. Do not stop without consulting health care professional. Take missed doses as soon as remembered during day. Do not double doses or take 2 doses in 1 day. Advise patient to read Medication Guide and Instructions for Use before starting therapy and with each Rx refill in case of changes.
• Instruct patient using never to exhale into inhaler device and always to hold device in a level horizontal position. Mouthpiece should be kept dry; never wash.
• Caution patient not to use umeclidinium/vilanterol to treat asthma or acute symptoms. A rapid-acting inhaled beta-adrenergic bronchodilator should be used for relief of acute attacks.
• Advise patient to notify health care professional immediately if difficulty in breathing persists after use of umeclidinium/vilanterol, if condition worsens, or if more inhalations of rapid-acting bronchodilator than usual are needed to relieve an acute attack.
• Advise patient to notify health care professional if signs and symptoms of urinary retention (difficulty urinating, painful urination, urinating frequently, urination in a weak stream or drips) or palpitations, chest pain, rapid heart rate, tremor, or nervousness occur
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Emphasize the importance of regular follow-up exams to determine progress during therapy.

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