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Trelegy Ellipta (Fluticasone Furoate/Umeclidinium/Vilanterol)

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Trelegy Ellipta (Fluticasone Furoate/Umeclidinium/Vilanterol) HIGHLIGHTS OF PRESCRIBING INFORMATION caution in patients with these infections. More serious or even fatal course These highlights do not include all the information needed to use of chickenpox or measles can occur in susceptible patients. (5.6) TRELEGY ELLIPTA safely and effectively. See full prescribing • Risk of impaired adrenal function when transferring from systemic information for TRELEGY ELLIPTA. corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY ELLIPTA. (5.7) TRELEGY ELLIPTA (fluticasone furoate, umeclidinium, and vilanterol • Hypercorticism and adrenal suppression may occur with very high inhalation powder), for oral inhalation dosages or at the regular dosage in susceptible individuals. If such Initial U.S. Approval: 2017 changes occur, consider appropriate therapy. (5.8) WARNING: ASTHMA-RELATED DEATH • If paradoxical bronchospasm occurs, discontinue TRELEGY ELLIPTA and institute alternative therapy. (5.10) See full prescribing information for complete boxed warning. • Use with caution in patients with cardiovascular disorders because of • Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase the risk of asthma-related death. A placebo-controlled trial beta-adrenergic stimulation. (5.12) with another LABA (salmeterol) showed an increase in • Assess for decrease in bone mineral density initially and periodically asthma-related deaths. This finding with salmeterol is considered a thereafter. (5.13) class effect of all LABA. (5.1) • Close monitoring for glaucoma and cataracts is warranted. Worsening of • The safety and efficacy of TRELEGY ELLIPTA in patients with narrow-angle glaucoma may occur. Use with caution in patients with asthma have not been established. TRELEGY ELLIPTA is not narrow-angle glaucoma and instruct patients to contact a healthcare indicated for the treatment of asthma. (5.1) provider immediately if symptoms occur. (5.14) • Worsening of urinary retention may occur. Use with caution in patients --------------------------- INDICATIONS AND USAGE ---------------------------­ with prostatic hyperplasia or bladder-neck obstruction and instruct TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled patients to contact a healthcare provider immediately if symptoms occur. corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a (5.15) • long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, Use with caution in patients with convulsive disorders, thyrotoxicosis, once-daily, maintenance treatment of patients with chronic obstructive diabetes mellitus, and ketoacidosis. (5.16) pulmonary disease (COPD), including chronic bronchitis and/or emphysema, • Be alert to hypokalemia and hyperglycemia. (5.17) who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment ------------------------------ ADVERSE REACTIONS -----------------------------­ of airflow obstruction is desired or for patients who are already receiving Most common adverse reactions (incidence ≥1%) are headache, back pain, umeclidinium and a fixed-dose combination of fluticasone furoate and dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis. (6.1) vilanterol. (1) To report SUSPECTED ADVERSE REACTIONS, contact Important limitations of use: Not indicated for relief of acute bronchospasm or GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or the treatment of asthma. (1, 5.2) www.fda.gov/medwatch. ------------------------------ 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. • Maintenance treatment of COPD: 1 inhalation of TRELEGY ELLIPTA (7.1) once daily. (2) • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on vascular system. --------------------- DOSAGE FORMS AND STRENGTHS ---------------------­ (7.2) Inhalation Powder: Inhaler containing 2 foil blister strips of powder • Beta-blockers: Use with caution. May block bronchodilatory effects of formulation for oral inhalation. One strip contains fluticasone furoate 100 mcg beta-agonists and produce severe bronchospasm. (7.3) per blister and the other contains umeclidinium/vilanterol 62.5 mcg/25 mcg • per blister. (3) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may ------------------------------ CONTRAINDICATIONS -----------------------------­ worsen with concomitant beta-agonists. (7.4) Severe hypersensitivity to milk proteins or any ingredients. (4) • Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of TRELEGY ----------------------- WARNINGS AND PRECAUTIONS -----------------------­ ELLIPTA with other anticholinergic-containing drugs. (7.5) • LABA increase the risk of asthma-related death. (5.1) • Do not initiate in acutely deteriorating COPD. Do not use to treat acute ----------------------- USE IN SPECIFIC POPULATIONS ----------------------­ symptoms. (5.2) Hepatic impairment: Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic • Do not use in combination with an additional medicine containing a corticosteroid effects. (8.6, 12.3) LABA because of risk of overdose. (5.3) • Candida albicans infection of the mouth and pharynx may occur. Monitor See 17 for PATIENT COUNSELING INFORMATION and Medication patients periodically. Advise the patient to rinse his/her mouth with water Guide. without swallowing after inhalation to help reduce the risk. (5.4) • Increased risk of pneumonia in patients with COPD. Monitor patients for Revised: 9/2017 signs and symptoms of pneumonia. (5.5) • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with ______________________________________________________________________________________________ 5.5 Pneumonia FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ASTHMA-RELATED DEATH 1 INDICATIONS AND USAGE 5.6 Immunosuppression 2 DOSAGE AND ADMINISTRATION 5.7 Transferring Patients from Systemic Corticosteroid Therapy 3 DOSAGE FORMS AND STRENGTHS 5.8 Hypercorticism and Adrenal Suppression 4 CONTRAINDICATIONS 5.9 Drug Interactions with Strong Cytochrome P450 3A4 5 WARNINGS AND PRECAUTIONS Inhibitors 5.1 Asthma-Related Death 5.10 Paradoxical Bronchospasm 5.2 Deterioration of Disease and Acute Episodes 5.11 Hypersensitivity Reactions, including Anaphylaxis 5.3 Excessive Use of TRELEGY ELLIPTA and Use with Other 5.12 Cardiovascular Effects Long-acting Beta2-agonists 5.13 Reduction in Bone Mineral Density 5.4 Local Effects of Inhaled Corticosteroids 1 Reference ID: 4154323 5.14 Glaucoma and Cataracts, Worsening of Narrow-Angle 8.6 Hepatic Impairment Glaucoma 8.7 Renal Impairment 5.15 Worsening of Urinary Retention 10 OVERDOSAGE 5.16 Coexisting Conditions 10.1 Fluticasone Furoate 5.17 Hypokalemia and Hyperglycemia 10.2 Umeclidinium 6 ADVERSE REACTIONS 10.3 Vilanterol 6.1 Clinical Trials Experience 11 DESCRIPTION 7 DRUG INTERACTIONS 12 CLINICAL PHARMACOLOGY 7.1 Inhibitors of Cytochrome P450 3A4 12.1 Mechanism of Action 7.2 Monoamine Oxidase Inhibitors and Tricyclic 12.2 Pharmacodynamics Antidepressants 12.3 Pharmacokinetics 7.3 Beta-adrenergic Receptor Blocking Agents 13 NONCLINICAL TOXICOLOGY 7.4 Non–Potassium-Sparing Diuretics 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 7.5 Anticholinergics 14 CLINICAL STUDIES 8 USE IN SPECIFIC POPULATIONS 14.1 Confirmatory Trials 8.1 Pregnancy 16 HOW SUPPLIED/STORAGE AND HANDLING 8.2 Lactation 17 PATIENT COUNSELING INFORMATION 8.4 Pediatric Use *Sections or subsections omitted from the full prescribing information are not 8.5 Geriatric Use listed. ___________________________________________________________________________________________ FULL PRESCRIBING INFORMATION WARNING: ASTHMA-RELATED DEATH Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in TRELEGY ELLIPTA, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. 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 [see Warnings and Precautions (5.1)]. The safety and efficacy of TRELEGY ELLIPTA in patients with asthma have not been established. TRELEGY ELLIPTA is not indicated for the treatment of asthma [see Warnings and Precautions (5.1)]. 1 INDICATIONS AND USAGE TRELEGY ELLIPTA is a combination inhaled corticosteroid/anticholinergic/long-acting beta2-adrenergic agonist indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Important Limitations
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