fluticasone/umeclidinium/vilanterol

Fluticasone

Absorption: 15.2% systemically absorbed from lungs following inhalation; minimal absorption from swallowing.

Distribution: Unknown.

Protein Binding: >99%.

Metabolism/Excretion: Primarily metabolized by the CYP3A4 isoenzyme to inactive metabolites; parent drug and metabolites excreted primarily in feces, 1–2% excreted in urine.

Half-Life: 24 hr

Umeclidinium

Absorption: Mostly absorbed from lungs; minimal oral absorption.

Distribution: Unknown.

Metabolism/Excretion: Primarily metabolized by the CYP2D6 isoenzyme to inactive metabolites; parent drug and metabolites excreted in feces (58%) and urine (22%).

Half-Life: 11 hr.

Vilanterol

Absorption: Mostly absorbed from lungs; minimal oral absorption.

Distribution: Unknown.

Protein Binding: 94%.

Metabolism/Excretion: Primarily metabolized by the CYP3A4 isoenzyme to inactive metabolites; parent drug and metabolites excreted in urine (70%) and feces (30%).

Half-Life: 11 hr.

Time/Action Profile ⬆ ⬇

(bronchodilation)

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

Contraind./Precautions ⬆ ⬇

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, or bladder-neck obstruction;
History of seizures, thyrotoxicosis, diabetes mellitus, or ketacidosis;
Renal impairment;
Hepatic 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: ARRHYTHMIAS, hypertension, QTc interval prolongation, tachycardia

EENT: cataracts, dysphonia, glaucoma, oral candidiasis

Endo: adrenal suppression, hyperglycemia

F and E: hypokalemia

GI: constipation, diarrhea

GU: urinary retention

MS: ↓bone mineral density, arthralgia, back pain

Neuro: dysgeusia, 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 risk of corticosteroid effects or adverse cardiovascular reactions; concurrent use should be undertaken with caution.
MAO inhibitors, tricyclic antidepressants, or QTc interval prolonging drugs may ↑ risk of cardiovascular reactions from vilanterol; exercise extreme caution when considering concurrent use or use within 2 wk of discontinuing above drugs.
Beta blockers may ↓ effectiveness of vilanterol and ↑ risk of severe bronchospasm; consider use of cardioselective beta blocker.
↑risk of hypokalemia with loop diuretics or thiazide diuretics.
↑risk of anticholinergic adverse reactions with other anticholinergics; avoid concurrent use.

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.

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

Assessment ⬆ ⬇

Monitor respiratory status, including lung sounds. Assess pulmonary function tests periodically during and for several months after a transfer from systemic to inhalation corticosteroids.
Assess for severe milk allergy prior to therapy; contains lactose.
Monitor for signs and symptoms of hypersensitivity reaction (rash, pruritus, swelling of face and neck, dyspnea) periodically during therapy.
Monitor ECG, BP, and HR periodically during therapy. May cause ↑ HR, ↑ BP, prolonged QTc interval, ST segment depression, supraventricular tachycardia, and extrasystoles.
Observe for paradoxical bronchospasm (wheezing, dyspnea, chest tightness) and hypersensitivity reaction (rash; urticaria; swelling of face, lips, or eyelids). If bronchospasm or hypersensitivity reaction occurs, hold therapy and support as clinically indicated.
Assess patients changing from systemic to inhalation corticosteroids for signs of adrenal insufficiency (anorexia, nausea, weakness, fatigue, hypotension, hypoglycemia) during initial therapy and periods of stress. If signs of adrenal insufficiency appear, notify health care provider immediately; condition may be life-threatening.
Monitor for withdrawal symptoms (joint or muscular pain, lassitude, depression) during withdrawal from systemic corticosteroids.
Monitor bone mineral density in patients on prolonged therapy and/or with ↑ risk (prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, chronic use of drugs that can reduce bone mass [anticonvulsants, oral corticosteroids]) for fractures.

Lab Test Considerations:

May cause hypokalemia and hyperglycemia.

Implementation ⬆ ⬇

Inhaln: Administer once daily at the same time each day. Do not open cover of inhaler until ready to use. Discard inhaler 6 wk after opening; inhaler is not reusable.
- See Medication Administration Techniques for administration of inhalation medications.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy and to follow instructions in Medication Guide for use of inhaler.
Advise patient to take medication as directed. If a dose is missed, take as soon as remembered unless almost time for next dose. Advise patient not to discontinue medication without consulting a health care provider; gradual ↓ is required.
Advise patient to rinse mouth with water without swallowing after administration to ↓ risk of oropharyngeal candidiasis.
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 provider immediately if symptoms worsen or more inhalations than usual are needed from rescue inhaler.
Advise patient to stop using medication and notify health care provider immediately if signs and symptoms of hypersensitivity reaction 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 provider 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), or sore throat or mouth occur.
Instruct patient to notify health care provider 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.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care provider before taking other Rx, OTC, or herbal products.
Advise patient to have regular eye examinations. Instruct patient to notify health care provider 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.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆