Adult Dosing

Long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with COPD

• 1 inhalation (25 mcg/100 mcg) PO qday

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD)

Note:

• Not indicated for relief of acute bronchospasm or for treatment of asthma

• Severe hypersensitivity to milk proteins
• Hypersensitivity to any of the ingredients of the product

• Long acting beta2-adrenergics (LABA), such as vilanterol may increase the risk of asthma related death. Data from a large placebo-controlled study showed increased asthma-related deaths in patients receiving salmeterol (another LABA) plus usual asthma treatment
• Safety and efficacy in patients with asthma have not been established. Not indicated for the treatment of asthma

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Mild hepatic impairment: Dose adjustments not defined
• Moderate-severe hepatic impairment: Dose adjustments not defined; caution advised

• Long acting beta2-adrenergics (LABA), such as vilanterol may increase the risk of asthma related death. Data from a large placebo-controlled study showed increased asthma-related deaths in patients receiving salmeterol (another LABA) plus usual asthma treatment [US black box warning]
• Safety and efficacy in patients with asthma have not been established. Not indicated for the treatment of asthma [US black box warning]
• For oral inhalation only
• Not indicated for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist
• Therapy should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD. The drug has not been studied in patients with acutely deteriorating COPD
• When initiating therapy, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs and to use them only for symptomatic relief of acute respiratory symptoms
• If the therapy no longer controls symptoms of bronchoconstriction or the patient needs more short-acting beta2-agonist than usual, re-evaluate the patient and the COPD treatment regimen
• Do not use more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs
• Patients should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason
• Localized infections of the mouth and pharynx with Candida albicans have occurred in subjects treated with this drug. If such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy
• An increase in the incidence of pneumonia has been observed in subjects with COPD receiving the fluticasone furoate/vilanterol combination
• Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
• Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals
• Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids
• Exceeding the recommended dosage or coadministration with a strong cytochrome P450 3A4 (CYP3A4) inhibitor may result in HPA dysfunction
• It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects
• Therapy may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs it should be treated immediately with an inhaled, short-acting bronchodilator; BREO ELLIPTA should be discontinued immediately and alternative therapy should be instituted
• Hypersensitivity reactions may occur following administration
• Vilanterol, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, therapy may need to be discontinued
• Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with COPD following the long-term administration of inhaled corticosteroids. Closely monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts
• Use with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines
• Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects

Pregnancy Category:C

Breastfeeding: Safety unknown. It is not known whether fluticasone or vilanterol are excreted in human breast milk. However, other corticosteroids and beta2-agonists have been detected in human milk. Since there are no data from controlled trials on the use of this drug by nursing mothers, caution should be exercised when it is administered to a nursing woman.

• EENT: Nasopharyngitis, oropharyngeal candidiasis, oropharyngeal pain, pharyngitis
• RESP: Upper respiratory tract infection, bronchitis, pneumonia, sinusitis, cough, influenza
• CNS: Headache, pyrexia
• MUSC: Back pain, arthralgia
• CV: Hypertension
• GI: Diarrhea
• MISC: Peripheral edema

Fluticasone

• Long-acting inhaled corticosteroid with anti-inflammatory activity; inhibits multiple cell types eg, mast cells, eosinophils, basophils, lymphocytes, macrophages, neutrophils and mediator production or secretion eg, histamine, eicosanoids, leukotrienes, cytokines involved in the asthmatic response
• Bioavailability: 15.2%
• Extensively metabolized by liver; CYP450: 3A4 (primarily)
• Excreted in feces; urine (< 5%)
• Half-life: 24 hrs

Vilanterol

• Long-acting selective beta 2-adrenergic agonist (LABA); stimulates intracellular adenyl cyclase resulting in increased cAMP levels causing bronchial smooth muscle relaxation and inhibition of release of mediators of immediate hypersensitivity especially from mast cells
• Bioavailability: 27.3%
• Mainly metabolized via CYP3A4, to a range of metabolites with significantly reduced beta1- and beta2-agonist activity
• Excretion: 30% feces; 70% urine
• Half-life: 21.3 hrs

US Trade Name(s)

• Breo ellipta

US Availability

Breo ellipta

• PWDR for INH: 100 mcg/25 mcg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Pulmonary

Bronchodilators

Bronchodilator Combinations

Allergy & Immunology

Bronchodilators

Bronchodilator Combinations