fluticasone/umeclidinium/vilanterol

Contraindicated in:

Hypersensitivity to any components or severe hypersensitivity to milk proteins;
Acute attack of COPD or asthma or status asthmaticus (onset of action is delayed).

Use Cautiously in:

Active untreated infections;
Cardiovascular disease;
Prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of anticonvulsants or oral corticosteroids (↑ risk of ↓ bone mineral density);
Narrow-angle glaucoma (may cause acute angle closure);
Cataracts
Urinary retention, prostatic hyperplasia, bladder-neck obstruction;
History of seizures, thyrotoxicosis, diabetes mellitus, or ketacidosis;
Hepatic or renal impairment;
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit outweighs potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may be more sensitive to drug effects.

Exercise Extreme Caution in:

Concurrent use of MAO inhibitors, tricyclic antidepressants, or QTc interval prolonging drugs.

Adv. Reactions/Side Effects ⬆ ⬇

CV: QTc interval prolongation, ARRHYTHMIAS, hypertension, tachycardia

EENT: cataracts, dysphonia, glaucoma, oral candidiasis

Endo: adrenal suppression, hyperglycemia

F and E: hypokalemia

GI: constipation, diarrhea, metallic taste

GU: urinary retention

MS: ↓bone mineral density, arthralgia, back pain

Neuro: headache

Resp: ↑risk of pneumonia, paradoxical bronchospasm

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

CYP3A4 inhibitors, including clarithromycin, conivaptan, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, or voriconazole may ↑ fluticasone and vilanterol levels and the risk of corticosteroid effects or adverse cardiovascular reactions; concurrent use should be undertaken with caution.
Concurrent use with MAO inhibitors, tricyclic antidepressants, or QTc interval prolonging drugs↑ risk of cardiovascular reactions from vilanterol; exercise extreme caution when considering concurrent use or use within 2 wk of discontinuing above drugs.
Concurrent use of beta-blockers may ↓ effectiveness of vilanterol and ↑ risk of severe bronchospasm; consider use of cardioselective beta-blocker.
↑risk of hypokalemia with concurrent use of loop diuretics or thiazide diuretics.
↑risk of anticholinergic adverse reactions when used concurrently with other anticholinergics; avoid concurrent use.

Availability ⬆ ⬇

Powder for inhalation (contains lactose): fluticasone 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg in a two-strip blister per dose; fluticasone 200 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg in a two-strip blister per dose

Route/Dosage ⬆ ⬇

COPD

Inhaln (Adults ): One inhalation (fluticasone 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily.

Asthma

Inhaln (Adults ): One inhalation (either fluticasone 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg or fluticasone 200 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily. If inadequate response to fluticasone 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg once daily, may ↑ to one inhalation (fluticasone 200 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Fluticasone: decreases airway inflammation; umeclidinium: acts as an anticholinergic by inhibiting M3 muscarinic receptors in bronchial smooth muscle resulting in bronchodilation; vilanterol: beta₂-adrenergic agonist that stimulates adenyl cyclase, resulting in accumulation of cyclic adenosine monophosphate and subsequent bronchodilation.

Therapeutic effects:

Improved airflow and ↓ exacerbations in COPD and asthma.

Classifications ⬆ ⬇

Therapeutic Classification: bronchodilators

Pharmacologic Classification: corticosteroids, anticholinergics, adrenergics

Pharmacokinetics ⬆ ⬇

Absorption: Fluticasone: 15.2% systemically absorbed from lungs following inhalation; minimal absorption from swallowing; umeclidinium: mostly absorbed from lungs; minimal oral absorption; vilanterol: mostly absorbed from lungs; minimal oral absorption.

Distribution: Unknown.

Protein Binding: Fluticasone: >99%, vilanterol: 94%.

Metabolism/Excretion: Fluticasone: primarily metabolized by the CYP3A4 isoenzyme to inactive metabolites; parent drug and metabolites excreted primarily in feces, 1–2% excreted in urine; umeclidinium: primarily metabolized by the CYP2D6 isoenzyme to inactive metabolites; parent drug and metabolites excreted in feces (58%) and urine (22%); vilanterol: primarily metabolized by the CYP3A4 isoenzyme to inactive metabolites; parent drug and metabolites excreted in urine (70%) and feces (30%).

Half-Life: Fluticasone: 24 hr; umeclidinium: 11 hr; vilanterol: 11 hr.

Time/Action Profile ⬆ ⬇

(bronchodilation)

ROUTE	ONSET	PEAK	DURATION
Inhalation	1 hr	2–12 hr	24 hr

Patient/Family Teaching ⬆ ⬇

Advise patient to take medication as directed. If a dose is missed, take as soon as remembered unless almost time for next dose. Instruct patient to read the Patient Information and Instructions for Use before using and with each Rx refill, in case of new information. Advise patient not to discontinue medication without consulting health care professional; gradual decrease is required.
Caution patient not to use medication to treat acute symptoms. A rapid-acting inhaled beta-adrenergic bronchodilator should be used for relief of acute asthma attacks. Notify health care professional immediately if symptoms get worse or more inhalations than usual are needed from rescue inhaler.
Advise patient to stop using medication and notify health care professional immediately if signs and symptoms of hypersensitivity reactions occur.
Instruct patient not to use additional long-acting Beta₂-agonists.
Caution patient to avoid smoking, known allergens, and other respiratory irritants.
Advise patient to notify health care professional if signs and symptoms of pneumonia (fever, chills, shortness of breath, increased cough, increased sputum production or change in mucus color), urinary retention (difficulty passing urine, painful urination), sore throat or mouth occur.
Instruct patient to notify health care professional immediately if exposed to chickenpox or measles. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking other Rx, OTC, or herbal products.
Advise patient to have regular eye examinations; may increase risk of cataracts and glaucoma. Instruct patient to notify health care professional immediately if signs and symptoms of glaucoma (eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion corneal edema) occur.
Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breast feeding.

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Indications ⬇

Contraind./Precautions ⬆ ⬇