umeclidinium

(redirected from Anoro Ellipta)

umeclidinium/vilanterol

(ue-mek-li-din-ee-um/vye-lan-ter-ol),

Anoro Ellipta

(trade name)

Classification

Therapeutic: bronchodilators
Pharmacologic: anticholinergics
Pregnancy Category: C

Indications

Maintenance management of airflow obstruction in patients with COPD.

Action

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

Therapeutic effects

Bronchodilation with decreased airflow obstruction.

Pharmacokinetics

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 and 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.

Time/action profile (bronchodilation)

ROUTEONSETPEAKDURATION
umeclidinium —Inhaln unknown2–4 hr24 hr
vilanterol—Inhalnunknown2–4 hr24 hr

Contraindications/Precautions

Contraindicated in: Severe/acute symptoms of airflow obstruction; Severe hypersensitivity to milk proteins or other ingredients;Concurrent use with other anticholinergics; Lactation: Discontinue drug or discontinue breastfeeding.
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; Geriatric: Elderly patients may be more sensitive to drug effects; Obstetric: Use during pregnancy only if potential benefit justifies potential fetal risk; Pediatric: Safe and effective use in children has not been established.
Exercise Extreme Caution in: Concurrent use with MAOIs or tricyclic antidepressants (↑ risk of adverse cardiovascular reactions from vilanterol).

Adverse Reactions/Side Effects

Combination

Central nervous system

  • headache
  • vertigo

Respiratory

  • cough
  • pharyngitis
  • sinusitis

Cardiovascular

  • chest pain
  • pleuritic pain

Gastrointestinal

  • abdominal pain
  • nausea

Musculoskeletal

  • arthralgia
  • back pain
  • extremity pain
  • muscle spasms
  • neck pain

Miscellaneous

  • hypersensitivity reactions
  • tooth pain
Umeclidinium

Ear, Eye, Nose, Throat

  • acute narrow-angle glaucoma

Respiratory

  • paradoxical bronchospasm (life-threatening)

Cardiovascular

  • chest pain

Genitourinary

  • urinary retention
Vilanterol

Cardiovascular

  • arrhythmias
  • ECG changes
  • hypertension

Endocrinologic

  • hyperglycemia

Fluid and Electrolyte

  • hypokalemia

Miscellaneous

  • asthma-related death (life-threatening)

Interactions

Drug-Drug interaction

↑ 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 withbeta blockers may ↓ effectiveness and cause severe bronchospasm (use cautiously). Should not be used concurrently with any other long-acting beta2-adrenergic blockers.

Route/Dosage

Inhalation (Adults) One inhalation (umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily.

Availability

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

Nursing implications

Nursing assessment

  • Assess lung sounds, pulse, and BP before administration and periodically during therapy.
  • Observe for paradoxical bronchospasm (wheezing, dyspnea, tightness in chest) and hypersensitivity reaction (rash; urticaria; swelling of the face, lips, or eyelids). If condition occurs, discontinue medication, notify health care professional immediately, and treat symptomatically.
  • Assess for signs and symptoms of acute narrow-angle glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Notify health care professional immediately if symptoms occur.
  • Lab Test Considerations: May cause hypokelamia and hyperglycemia.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Activity intolerance

Implementation

  • See for administration of inhalation medications. Once removed from foil tray, discard inhaler when counter reads 0 or 6 wk have passed, whichever comes first. Inhaler is not reusable; do not attempt to take inhaler apart.
    • When umeclidinium/vilanterol is administered concurrently with other inhalation medications, administer short-acting adrenergic bronchodilators first, followed by umeclidinium/vilanterol, then corticosteroids. Wait 5 min between medications.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • Decreased dyspnea
    • Improved breath sounds in patients with COPD.
References in periodicals archive ?
Anoro Ellipta sales grew 41% AER, 48% CER to [pounds sterling]120 million, driven by gains in the US.
The label update is based on data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study which showed Trelegy Ellipta was superior to both the ICS/LABA Relvar/Breo Ellipta (FF/VI) and long-acting muscarinic receptor antagonist (LAMA)/LABA Anoro Ellipta (UMEC/VI) in patients with moderate to severe COPD on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.
The CHMP's recommendation is based on a type II variation supported by data from the IMPACT study which indicated that Trelegy Ellipta was superior to the inhaled corticosteroid (ICS)/LABA Relvar/Breo Ellipta (FF/VI) and LAMA/LABA Anoro Ellipta (UMEC/VI) in patients with moderate to severe COPD on multiple clinically important endpoints, including decreasing exacerbations and improving lung function and health related quality of life.
Geographies covered: US Germany France Italy Spain UK Japan Australia Canada Drugs covered Spiriva Tudorza Pressair Seebri Neohaler Incruse Ellipta Arcapta Neohaler/Onbrez Striverdi Respimat Advair/Seretide Symbicort Turbuhaler Breo Ellipta Ultibro/Utibron Anoro Ellipta Brimica Genuair/Duaklir Stiolto Respimat Daliresp/Daxas Trelegy Ellipta Trimbow Arnuity Ellipta Bevespi Aerosphere Lonhala Magnair Revefenacin PT010 Nucala RPL554 Fasenra Disease Indication Overview: This section of the report gives the overview of COPD disease indication in detail.
Aguiar, chief executive officer, and will lead Theravance's growth strategy and corporate development initiatives beyond the company's existing respiratory portfolio of RELVAR/BREO ELLIPTA and ANORO ELLIPTA.
The Food and Drug Administration approved umedidinium/vilanterol combination therapy (Anoro Ellipta) in December 2013, the first LAMA/LABA therapy approved in the United States.
Within e Journal North 40, shares in GLAXOSMITHKLINE traded lower despite news that the Japanese Ministry of Health, Labour and Welfare has approved Anoro Ellipta, a drug which GLAXOSMITHKLINE produces, in order to relieve airway obstruction.
Two new respiratory combination products were approved in 2013, both for chronic obstructive pulmonary disease: fluticasone/ vilanterol (Breo Ellipta) and umeclidinium/vilanterol (Anoro Ellipta).
In the overall study population, FF/UMEC/VI was superior to the ICS/LABA Relvar/Breo Ellipta (FF/VI) and the LAMA/LABA Anoro Ellipta (UMEC/VI) on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.
today announced positive data from a study comparing a once-daily long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA) fixed-dose combination, Anoro Ellipta (umeclidinium/vilanterol 62.5mcg/25mcg; UMEC/VI) and Stiolto Respimat (tiotropium/olodaterol 5mcg/5mcg; TIO/OLO), for symptomatic patients with chronic obstructive pulmonary disease (COPD).
The product received approval based on a supplemental New Drug Application supported by data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study, which indicated that Trelegy Ellipta was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), Relvar/Breo Ellipta (FF/VI), and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), Anoro Ellipta (UMEC/VI), on multiple clinically important endpoints, including decreasing exacerbations and improving lung function and health related quality of life.
Exploratory data for GSKs dual bronchodilator treatment for COPD, Anoro Ellipta (umeclidinium/vilanterol, UMEC/VI), investigates the risk of experiencing clinically important deteriorations in COPD, following an escalation of treatment from single bronchodilator tiotropium to UMEC/VI.