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brand breo ellipta 200-25 mcg inh

In stock Manufacturer GLAXOSMITHKLINE 00173088210
$390.97 / Blist Pack

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Uses

Bronchospasm

Chronic Obstructive Pulmonary Disease

Vilanterol trifenatate is used in fixed combination with fluticasone furoate (a corticosteroid) or umeclidinium bromide (an antimuscarinic agent) as a bronchodilator for the long-term maintenance treatment of airflow obstruction associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Vilanterol trifenatate in fixed combination with fluticasone furoate also is used to reduce exacerbations of COPD in patients with a history of such exacerbations. Vilanterol trifenatate in fixed combination with fluticasone furoate is not indicated for the treatment of acute bronchospasm. Vilanterol trifenatate in fixed combination with umeclidinium bromide is not indicated for the treatment of acute bronchospasm or for the treatment of asthma.

Efficacy of vilanterol in combination with fluticasone furoate has been evaluated in 2 randomized, double-blind, placebo-controlled studies of 24 weeks' duration in adults 40 years of age or older with moderate to severe COPD. The primary efficacy outcomes were the weighted mean postdose (0-4 hours) forced expiratory volume in 1 second (FEV1) on day 168 and the change from baseline in the trough FEV1 on day 169. In these studies, orally inhaled vilanterol (25 mcg once daily) in fixed combination with fluticasone furoate (100 mcg once daily) improved postdose FEV1 at 168 days by 173-214 mL compared with placebo and by 120-168 mL compared with fluticasone furoate alone. The change from baseline in trough FEV1 improved by 115-144 mL compared with placebo at 169 days.

In 2 randomized, double-blind studies of 12 months' duration in patients with COPD and moderate to severe airflow obstruction, orally inhaled vilanterol (25 mcg once daily) in fixed combination with fluticasone furoate (100 mcg once daily) resulted in a decreased mean annual rate of COPD exacerbations compared with vilanterol alone (0.7-0.9 versus 1.05-1.14 exacerbations per year).

Efficacy of vilanterol in combination with umeclidinium bromide has been evaluated in a randomized, double-blind, placebo-controlled study of 24 weeks' duration in adults 40 years of age or older with COPD. The primary efficacy outcome was the change from baseline in the trough FEV1 on day 169. Following administration of orally inhaled vilanterol 25 mcg in fixed combination with umeclidinium 62.5 mcg once daily, the change from baseline in trough FEV1 at 169 days improved by 52, 95, and 167 mL compared with umeclidinium alone, vilanterol alone, and placebo, respectively.

For additional information on the treatment of COPD,

Dosage and Administration

Administration

Vilanterol trifenatate in combination with fluticasone furoate is administered by oral inhalation using a specific preloaded inhaler (Breo Ellipta) that delivers a fixed combination of powdered vilanterol trifenatate and fluticasone furoate from foil-wrapped blisters. Vilanterol trifenatate in combination with umeclidinium bromide is administered by oral inhalation using a specific preloaded inhaler (Anoro Ellipta) that delivers a fixed combination of powdered vilanterol trifenatate and umeclidinium bromide from foil-wrapped blisters. Vilanterol trifenatate in fixed combination with fluticasone furoate or umeclidinium bromide should be administered once daily at the same time every day.

Before first use of either the Breo Ellipta or Anoro Ellipta inhaler, the device should be removed from the foil tray and the enclosed desiccant should be discarded out of reach of children and pets. The date the tray is opened and the discard date (6 weeks after opening) should be written on the inhaler label. The number of doses remaining in the inhaler is displayed on the counter located on the front of the device. The cover of the inhaler should not be opened until immediately before use; to avoid wasting doses, the inhaler cover should not be closed again until the dose has been inhaled. When the cover of the inhaler is opened fully to expose the mouthpiece, a click should be heard. If the dose counter does not advance when the click is heard, the dose has not been properly prepared, and the patient should contact the clinician.

Before inhaling the dose, the patient should exhale completely, but should not exhale into the mouthpiece of the inhaler. The patient should then place the mouthpiece between the lips and inhale deeply through the inhaler with a steady, even breath; the patient should not inhale through the nose. The air vent on the inhaler should not be blocked while the dose is administered. The patient should remove the inhaler from the mouth, hold the breath for about 3-4 seconds (or as long as comfortable), and then exhale slowly and gently. While some patients may taste or feel a dose of drug delivered from the inhaler, patients should be instructed not to use another dose even if they do not perceive that the dose has been delivered. After the dose is administered, the inhaler should be closed by sliding the cover up and over the mouthpiece as far as possible.

Rinsing the mouth with water (without swallowing) after inhalation of vilanterol in fixed combination with fluticasone furoate is advised.

The inhaler does not need to be cleaned after use. However, if desired, the mouthpiece can be cleaned with a dry tissue. The inhaler should be discarded when every blister has been used or 6 weeks after removal of the inhaler from the foil tray, whichever comes first.

Dosage

Dosage of vilanterol trifenatate is expressed in terms of vilanterol.

Each foil-wrapped blister in the Breo Ellipta inhaler device contains 40 mcg of vilanterol trifenatate (equivalent to 25 mcg of vilanterol) or 100 mcg of fluticasone furoate (in separate blisters). After the inhaler is activated, the powder within a pair of blisters is exposed and dispersed into the air stream created by the patient's inhalation. Using standardized in vitro testing at a flow rate of 60 L/minute for 4 seconds, the inhaler delivered 22 mcg of vilanterol and 92 mcg of fluticasone furoate per pair of blisters. The precise amount of drug delivered to the lungs with each activation of the inhaler device depends on factors such as the patient's inspiratory flow. The commercially available inhaler delivers 30 doses (or 14 doses from the sample or institutional package).

Each foil-wrapped blister in the Anoro Ellipta inhaler device contains 40 mcg of vilanterol trifenatate (equivalent to 25 mcg of vilanterol) or 74.2 mcg of umeclidinium bromide (equivalent to 62.5 mcg of umeclidinium) (in separate blisters). After the inhaler is activated, the powder within a pair of blisters is exposed and dispersed into the air stream created by the patient's inhalation. Using standardized in vitro testing at a flow rate of 60 L/minute for 4 seconds, the inhaler delivered 22 mcg of vilanterol and 55 mcg of umeclidinium per pair of blisters. The precise amount of drug delivered to the lungs with each activation of the inhaler device depends on factors such as the patient's inspiratory flow. The commercially available inhaler delivers 30 doses (or 7 doses from the sample or institutional package).

Chronic Obstructive Pulmonary Disease

Vilanterol/Fluticasone Furoate Fixed-combination Therapy

For maintenance therapy of chronic obstructive pulmonary disease (COPD), the recommended dosage of vilanterol in fixed combination with fluticasone furoate in adults is 25 mcg of vilanterol and 100 mcg of fluticasone furoate (1 inhalation) once daily via the Breo Ellipta inhaler device. The drug should not be administered more frequently than once every 24 hours. If a dose of vilanterol in fixed combination with fluticasone furoate is missed, the dose may be taken as soon as it is remembered. However, 2 doses should not be taken at the same time.

Vilanterol/Umeclidinium Bromide Fixed-combination Therapy

For maintenance therapy of COPD, the recommended dosage of vilanterol in fixed combination with umeclidinium in adults is 25 mcg of vilanterol and 62.5 mcg of umeclidinium (1 inhalation) once daily via the Anoro Ellipta inhaler device. The drug should not be administered more frequently than once every 24 hours. If a dose of vilanterol in fixed combination with umeclidinium bromide is missed, the dose may be taken as soon as it is remembered. However, 2 doses should not be taken at the same time.

Special Populations

The manufacturer of vilanterol in fixed combination with fluticasone furoate states that dosage adjustment is not required in geriatric patients or in patients with hepatic or renal impairment.(See Specific Populations under Cautions: Warnings/Precautions.)

The manufacturer of vilanterol in fixed combination with umeclidinium bromide states that dosage adjustment is not required in geriatric patients or in patients with renal impairment or moderate hepatic impairment.(See Specific Populations under Cautions: Warnings/Precautions.)

Cautions

Contraindications

Known hypersensitivity to vilanterol trifenatate or any other ingredient in the commercially available formulation. Known severe hypersensitivity to milk proteins.

When vilanterol trifenatate is used in fixed combination with fluticasone furoate or umeclidinium bromide, contraindications associated with fluticasone or umeclidinium should be considered.

Warnings/Precautions

Warnings

Use of Fixed Combinations

When vilanterol trifenatate is used in fixed combination with fluticasone furoate or umeclidinium bromide, the usual cautions, precautions, contraindications, and interactions associated with fluticasone furoate or umeclidinium bromide must be considered. Cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, or geriatric patients) should be considered for each drug in the fixed combinations.

Asthma-related Death

Long-acting β2-adrenergic agonists, such as vilanterol, increase the risk of asthma-related death. In addition, available data from controlled clinical trials suggest that long-acting β2-adrenergic agonists increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

Data from a large placebo-controlled safety study (Salmeterol Multicenter Asthma Research Trial [SMART]) showed an increase in asthma-related deaths in patients receiving certain long-acting β2-adrenergic agonists (e.g., salmeterol) in addition to usual asthma therapy. The increased risk of asthma-related death with salmeterol is considered a class effect of the long-acting β2-adrenergic agonists, including vilanterol. However, no adequate studies have been conducted to determine whether the rate of asthma-related death is increased with vilanterol. The US Food and Drug Administration (FDA) is requiring manufacturers of long-acting β2-adrenergic agonists to conduct additional clinical trials to further evaluate the safety of long-acting β2-adrenergic agonists when used concomitantly with inhaled corticosteroids.

Data are not available to determine whether the rate of death is increased in patients with chronic obstructive pulmonary disease (COPD) receiving long-acting β2-adrenergic agonists, including vilanterol.

Other Warnings and Precautions

Deterioration of Disease and Acute Episodes

Vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide should not be initiated in patients with acutely deteriorating COPD, which may be life-threatening. Vilanterol has not been studied in this patient population, and initiation of vilanterol in this setting is not appropriate.

Vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide should not be used for the relief of acute symptoms (i.e., as rescue therapy for the treatment of acute episodes of bronchospasm). Vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide has not been studied for the relief of acute symptoms and extra doses of the drug should not be used for this purpose. All patients receiving vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide should be provided with and instructed in the use of a short-acting, inhaled β2-agonist.

When vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide is initiated in patients receiving short-acting, oral or inhaled β2-agonists on a regular basis (e.g., 4 times daily), regular use of the short-acting agent should be discontinued, and such agents should be used only for symptomatic relief of acute respiratory symptoms.

COPD may deteriorate acutely over a period of hours or chronically over several days or longer. Failure to respond to a previously effective dosage of vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide or to a supplemental short-acting, inhaled β2-agonist (e.g., increased need for additional short-acting, inhaled β2-agonists) may indicate deterioration of COPD for which prompt medical attention is indicated. In this setting, immediate reevaluation of the patient and treatment regimen is required. Increasing the daily dosage of vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide to exceed the recommended dosage is not appropriate in this situation.

Excessive Use and Use With Other Long-acting β2-Adrenergic Agonists

Clinically important cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

As with other inhaled β2-adrenergic agonists, vilanterol should not be used more frequently or at dosages higher than recommended, or concomitantly with other preparations containing long-acting β2-adrenergic agonists, since overdosage may result. Vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide should not be used with another preparation containing a long-acting β2-agonist (e.g., arformoterol, formoterol, indacaterol, olodaterol, salmeterol) for any reason.

Paradoxical Bronchospasm

As with other inhaled drugs, patients receiving vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide may develop paradoxical bronchospasm, which may be life-threatening.

If paradoxical bronchospasm occurs, it should be treated immediately with an inhaled, short-acting bronchodilator. Vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide should be discontinued immediately and alternative therapy instituted.

Sensitivity Reactions

Hypersensitivity reactions may occur after administration of vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide. Anaphylactic reactions have been reported following oral inhalation of other powder preparations containing lactose in patients with severe hypersensitivity to milk proteins; therefore, patients with severe milk protein allergy should not use vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide.(See Cautions: Contraindications.)

Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported during postmarketing surveillance of vilanterol in fixed combination with fluticasone furoate.

Cardiovascular Effects

Vilanterol, like other β2-adrenergic agonists, may produce a clinically important cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or cardiac arrhythmias (e.g., supraventricular tachycardia, extrasystoles). If such effects occur, discontinuance of vilanterol therapy may be required.

In addition, β2-adrenergic agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the corrected QT (QTc) interval, and ST-segment depression; the clinical importance of these effects is unknown. Administration of large dosages of orally inhaled vilanterol in combination with fluticasone furoate (i.e., 4 times the recommended dosage of vilanterol, representing a systemic exposure 12-fold higher than that observed in patients with COPD) in healthy individuals resulted in clinically important prolongation of the QTc interval, which may cause ventricular arrhythmias. Therefore, vilanterol, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, or hypertension.

No clinically important effects on heart rate, QTc, or blood pressure were observed in patients with COPD receiving vilanterol alone or in combination with fluticasone furoate in clinical trials. No clinically important effects on cardiac rhythm were observed in patients with COPD receiving vilanterol in combination with umeclidinium bromide in clinical trials, and no clinically important effects on QTc were observed in studies in healthy individuals.

Metabolic and Electrolyte Effects

Vilanterol, like other sympathomimetic amines, should be used with caution in patients with thyrotoxicosis.

IV doses of the β2-adrenergic agonist albuterol (IV preparation not commercially available in the US) have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. β2-Adrenergic agonists may cause transient hyperglycemia in some patients.

Clinically important hypokalemia, which may result in adverse cardiovascular effects, may occur in some patients receiving β2-adrenergic agonists, possibly through intracellular shunting.(See Cardiovascular Effects under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) However, the decrease in serum potassium concentrations usually is transient and generally does not require supplementation.

Changes in serum glucose or potassium concentrations were not observed in patients with COPD receiving vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide in clinical trials of 6 or 12 months' duration.

Nervous System Effects

Vilanterol, like other sympathomimetic amines, should be used with caution in patients with seizure disorders and in those unusually responsive to sympathomimetic amines.

Specific Populations

Pregnancy

Category C.

The effects of vilanterol on labor and delivery are not known. Because of the potential for β-agonist interference with uterine contractility, use of vilanterol during labor should be restricted to those patients in whom the benefits clearly outweigh the risks.

Lactation

It is not known whether vilanterol is distributed into human milk; however, other β2-adrenergic agonists are distributed into human milk. The manufacturer recommends that vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide should be used with caution in nursing women.

Pediatric Use

Vilanterol is not indicated for use in pediatric patients. Safety and efficacy have not been established in pediatric patients.

Geriatric Use

In clinical trials evaluating vilanterol in fixed combination with fluticasone furoate in patients with COPD, approximately 33% of patients receiving the drug were 65 years of age or older, and about 7% were 75 years of age or older. In clinical trials evaluating vilanterol in fixed combination with umeclidinium bromide in patients with COPD, approximately 29% of patients receiving the drug were 65 years of age or older, and about 7% were 75 years of age or older. Although no overall differences in safety and efficacy were observed between geriatric and younger adults, and other clinical experience revealed no evidence of age-related differences, the possibility that some geriatric patients may exhibit increased sensitivity to the drug cannot be ruled out. Dosage adjustment is not necessary in geriatric patients.

Hepatic Impairment

Following repeated daily dosing of vilanterol in fixed combination with fluticasone furoate for 7 days, no clinically important changes in peak plasma concentrations or area under the serum concentration-time curve (AUC) of vilanterol were observed in patients with mild, moderate, or severe hepatic impairment. However, increases of 34, 83, and 75% in AUC of fluticasone were observed in patients with mild, moderate, or severe hepatic impairment, respectively, compared with healthy individuals. Therefore, the manufacturer states that vilanterol in fixed combination with fluticasone furoate should be used with caution in patients with moderate or severe hepatic impairment. Dosage adjustment of vilanterol in fixed combination with fluticasone furoate is not required in patients with hepatic impairment.

Following administration of vilanterol in fixed combination with umeclidinium bromide, no clinically important changes in peak plasma concentrations or AUC of vilanterol or umeclidinium were observed in patients with moderate hepatic impairment. Therefore, the manufacturer states that dosage adjustment of vilanterol in fixed combination with umeclidinium is not required in patients with moderate hepatic impairment. Vilanterol in fixed combination with umeclidinium has not been studied in patients with severe hepatic impairment.

Renal Impairment

Following administration of vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide, no clinically important increases in vilanterol, fluticasone, or umeclidinium exposure were observed in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) compared with individuals with normal renal function. However, the AUC of vilanterol was 56% higher in individuals with severe renal impairment compared with those having normal renal function. The manufacturer states that dosage adjustment is not required in patients with renal impairment.

Common Adverse Effects

Adverse effects reported in 3% or more of patients with COPD receiving vilanterol in fixed combination with fluticasone furoate in controlled clinical studies include nasopharyngitis, headache, upper respiratory tract infection, and oropharyngeal candidiasis.

Adverse effects reported in 1% or more of patients with COPD receiving vilanterol in fixed combination with umeclidinium bromide in controlled clinical studies include pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, extremity pain, muscle spasms, neck pain, and chest pain.

Drug Interactions

Vilanterol is a substrate of cytochrome P-450 (CYP) isoenzyme 3A4 and P-glycoprotein (P-gp).

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes and/or the P-glycoprotein Transport System

Concomitant use of vilanterol with potent inhibitors of CYP3A4 (e.g., clarithromycin, conivaptan, ketoconazole, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole) is expected to result in increased systemic exposure to vilanterol.

Concomitant administration of ketoconazole 400 mg daily resulted in a 65% increase in area under the serum concentration-time curve (AUC) of vilanterol; associated increases in β-agonist-related effects on heart rate or potassium concentrations were not observed. Caution should be exercised when vilanterol is used in patients receiving long-term therapy with ketoconazole or other potent CYP3A4 inhibitors.

Concomitant administration of multiple daily 240-mg doses of verapamil (a potent P-gp inhibitor and moderate CYP3A4 inhibitor) did not affect peak plasma concentrations or AUC of vilanterol in healthy individuals. Dosage adjustment of vilanterol is not required with concomitant use.

Drugs that Prolong the QT Interval

Vilanterol, like other β2-adrenergic agonists, should be used with extreme caution in patients who are receiving or have recently received (i.e., within 2 weeks) drugs known to prolong the corrected QT (QTc) interval because of the increased risk of ventricular arrhythmias and because such drugs may potentiate the effects of adrenergic drugs on the cardiovascular system.

β-Adrenergic Blocking Agents

β-Adrenergic blocking agents may interfere with the actions of vilanterol when the drugs are used concomitantly. β-Adrenergic blocking agents not only block the therapeutic effects of β2-adrenergic agonists, but also may produce severe bronchospasm in patients with chronic obstructive pulmonary disease (COPD). Patients with COPD usually should not be treated with β-adrenergic blocking agents. However, under certain circumstances (e.g., prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of β-adrenergic blocking agents in these patients; the use of cardioselective β-adrenergic blocking agents may be considered but vilanterol and β-adrenergic blocking agents should be used concomitantly with caution.

Diuretics

The ECG and/or hypokalemic effects that may result from the administration of non-potassium-sparing diuretics (e.g., loop or thiazide diuretics) may be aggravated by concomitant use of β-agonists, especially when the recommended dosage of the β-agonist is exceeded; the clinical importance is unknown. β-Agonists and non-potassium-sparing diuretics should be used concomitantly with caution.

Monoamine Oxidase Inhibitors

The manufacturer states that the effects of vilanterol on the cardiovascular system may be potentiated in patients receiving concomitant therapy with monoamine oxidase (MAO) inhibitors; therefore, vilanterol should be used with extreme caution in patients who are receiving or have recently received (i.e., within 2 weeks) these drugs.

Sympathomimetic Agents

Other preparations containing long-acting β2-adrenergic agonists (e.g., arformoterol, formoterol, indacaterol, olodaterol, salmeterol) should not be used for any reason in patients receiving vilanterol in fixed combination with fluticasone furoate or umeclidinium bromide.

Tricyclic Antidepressants

The manufacturer states that the effects of vilanterol on the cardiovascular system may be potentiated in patients receiving concomitant therapy with tricyclic antidepressants; therefore, vilanterol should be used with extreme caution in patients who are receiving or have recently received (i.e., within 2 weeks) these drugs.

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