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BREO • Do Not Use in Combination with an Additional Medicine Containing a ELLIPTA Safely and Effectively

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BREO • Do Not Use in Combination with an Additional Medicine Containing a ELLIPTA Safely and Effectively HIGHLIGHTS OF PRESCRIBING INFORMATION treat acute symptoms. (5.2) These highlights do not include all the information needed to use BREO • Do not use in combination with an additional medicine containing a ELLIPTA safely and effectively. See full prescribing information for LABA because of risk of overdose. (5.3) BREO ELLIPTA. • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water BREO ELLIPTA 100/25 (fluticasone furoate 100 mcg and vilanterol without swallowing after inhalation to help reduce the risk. (5.4) 25 mcg inhalation powder), for oral inhalation • Increased risk of pneumonia in patients with COPD. Monitor patients for BREO ELLIPTA 200/25 (fluticasone furoate 200 mcg and vilanterol signs and symptoms of pneumonia. (5.5) 25 mcg inhalation powder), for oral inhalation • Potential worsening of infections (e.g., existing tuberculosis; fungal, Initial U.S. Approval: 2013 bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course WARNING: ASTHMA-RELATED DEATH of chickenpox or measles can occur in susceptible patients. (5.6) See full prescribing information for complete boxed warning. • Risk of impaired adrenal function when transferring from systemic • Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, corticosteroids. Taper patients slowly from systemic corticosteroids if increase the risk of asthma-related death. A placebo-controlled trial transferring to BREO ELLIPTA. (5.7) with another LABA (salmeterol) showed an increase in • Hypercorticism and adrenal suppression may occur with very high asthma-related deaths. This finding with salmeterol is considered a dosages or at the regular dosage in susceptible individuals. If such class effect of all LABA. Currently available data are inadequate to changes occur, discontinue BREO ELLIPTA slowly. (5.8) determine whether concurrent use of inhaled corticosteroids (ICS) or • If paradoxical bronchospasm occurs, discontinue BREO ELLIPTA and other long-term asthma control drugs mitigates the increased risk of institute alternative therapy. (5.10) asthma-related death from LABA. Available data from controlled • clinical trials suggest that LABA increase the risk of asthma-related Use with caution in patients with cardiovascular disorders because of hospitalization in pediatric and adolescent patients. (5.1) beta-adrenergic stimulation. (5.12) • • When treating patients with asthma, only prescribe BREO ELLIPTA Assess for decrease in bone mineral density initially and periodically for patients not adequately controlled on a long-term asthma control thereafter. (5.13) medication, such as an ICS, or whose disease severity clearly • Close monitoring for glaucoma and cataracts is warranted. (5.14) warrants initiation of treatment with both an ICS and a LABA. Once • Use with caution in patients with convulsive disorders, thyrotoxicosis, asthma control is achieved and maintained, assess the patient at diabetes mellitus, and ketoacidosis. (5.15) regular intervals and step down therapy (e.g., discontinue BREO • Be alert to hypokalemia and hyperglycemia. (5.16) ELLIPTA) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an ICS. ------------------------------ ADVERSE REACTIONS -----------------------------­ Do not use BREO ELLIPTA for patients whose asthma is adequately • COPD: Most common adverse reactions (incidence greater than or equal controlled on low- or medium-dose ICS. (1.2, 5.1) to 3%) are nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, --------------------------- INDICATIONS AND USAGE ---------------------------­ oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, and BREO ELLIPTA is a combination of fluticasone furoate, an inhaled pyrexia. (6.1) • corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist Asthma: Most common adverse reactions (incidence greater than or equal (LABA), indicated for: to 2%) are nasopharyngitis, oral candidiasis, headache, influenza, upper • Long-term, once-daily, maintenance treatment of airflow obstruction and respiratory tract infection, bronchitis, sinusitis, oropharyngeal pain, reducing exacerbations in patients with chronic obstructive pulmonary dysphonia, and cough. (6.2) disease (COPD). (1.1) To report SUSPECTED ADVERSE REACTIONS, contact • Once-daily treatment of asthma in patients aged 18 years and older. (1.2) GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or Important limitation: Not indicated for relief of acute bronchospasm. (1.1, 1.2, www.fda.gov/medwatch. 5.2) ------------------------------ DRUG INTERACTIONS------------------------------­ ----------------------- DOSAGE AND ADMINISTRATION ----------------------­ • Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with • For oral inhalation only. (2) caution. May cause systemic corticosteroid and cardiovascular effects. (7.1) • Maintenance treatment of COPD: 1 inhalation of BREO ELLIPTA 100/25 once daily. (2.1) • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on vascular system. • Asthma: 1 inhalation of BREO ELLIPTA 100/25 or BREO ELLIPTA 200/25 once daily. (2.2) (7.2) • Beta-blockers: Use with caution. May block bronchodilatory effects of --------------------- DOSAGE FORMS AND STRENGTHS ---------------------­ beta-agonists and produce severe bronchospasm. (7.3) Inhalation Powder. Inhaler containing 2 foil blister strips of powder • Diuretics: Use with caution. Electrocardiographic changes and/or formulation for oral inhalation. One strip contains fluticasone furoate 100 or hypokalemia associated with non–potassium-sparing diuretics may 200 mcg per blister and the other contains vilanterol 25 mcg per blister. (3) worsen with concomitant beta-agonists. (7.4) ------------------------------ CONTRAINDICATIONS -----------------------------­ ----------------------- USE IN SPECIFIC POPULATIONS ----------------------­ • Primary treatment of status asthmaticus or acute episodes of COPD or Hepatic impairment: Fluticasone furoate exposure may increase in patients asthma requiring intensive measures. (4) with moderate or severe impairment. Monitor for systemic corticosteroid • Severe hypersensitivity to milk proteins or any ingredients. (4) effects. (8.6, 12.3) ----------------------- WARNINGS AND PRECAUTIONS -----------------------­ See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. • LABA increase the risk of asthma-related death and asthma-related hospitalizations. Prescribe only for recommended patient populations. Revised: 5/2017 (5.1) • Do not initiate in acutely deteriorating COPD or asthma. Do not use to FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ASTHMA-RELATED DEATH 1.2 Treatment of Asthma 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary 2.1 Chronic Obstructive Pulmonary Disease Disease 2.2 Asthma 1 Reference ID: 4098273 3 DOSAGE FORMS AND STRENGTHS 7.2 Monoamine Oxidase Inhibitors and Tricyclic 4 CONTRAINDICATIONS Antidepressants 5 WARNINGS AND PRECAUTIONS 7.3 Beta-adrenergic Receptor Blocking Agents 5.1 Asthma-Related Death 7.4 Non–Potassium-Sparing Diuretics 5.2 Deterioration of Disease and Acute Episodes 8 USE IN SPECIFIC POPULATIONS 5.3 Excessive Use of BREO ELLIPTA and Use with Other 8.1 Pregnancy Long-acting Beta2-agonists 8.2 Lactation 5.4 Local Effects of Inhaled Corticosteroids 8.4 Pediatric Use 5.5 Pneumonia 8.5 Geriatric Use 5.6 Immunosuppression 8.6 Hepatic Impairment 5.7 Transferring Patients from Systemic Corticosteroid Therapy 8.7 Renal Impairment 5.8 Hypercorticism and Adrenal Suppression 10 OVERDOSAGE 5.9 Drug Interactions with Strong Cytochrome P450 3A4 10.1 Fluticasone Furoate Inhibitors 10.2 Vilanterol 5.10 Paradoxical Bronchospasm 11 DESCRIPTION 5.11 Hypersensitivity Reactions, Including Anaphylaxis 12 CLINICAL PHARMACOLOGY 5.12 Cardiovascular Effects 12.1 Mechanism of Action 5.13 Reduction in Bone Mineral Density 12.2 Pharmacodynamics 5.14 Glaucoma and Cataracts 12.3 Pharmacokinetics 5.15 Coexisting Conditions 13 NONCLINICAL TOXICOLOGY 5.16 Hypokalemia and Hyperglycemia 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.17 Effect on Growth 14 CLINICAL STUDIES 6 ADVERSE REACTIONS 14.1 Chronic Obstructive Pulmonary Disease 6.1 Clinical Trials Experience in Chronic Obstructive 14.2 Asthma Pulmonary Disease 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Clinical Trials Experience in Asthma 17 PATIENT COUNSELING INFORMATION 6.3 Postmarketing Experience *Sections or subsections omitted from the full prescribing information are not 7 DRUG INTERACTIONS listed. 7.1 Inhibitors of Cytochrome P450 3A4 FULL PRESCRIBING INFORMATION WARNING: ASTHMA-RELATED DEATH Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in BREO ELLIPTA, increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of LABA. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids (ICS) or other
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