The only COPD Triple Therapy delivered in a single daily inhalation.1 Improvement in quality of life vs. ICS/LABA.2
A combination of ICS/LAMA/LABA (FF/UMEC/VI) administered through a single daily inhalation from the Ellipta inhaler, which is easy to use1–4
Trelegy Ellipta FF/UMEC/VI 92/55/22 mcg is indicated for maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an ICS and a LABA.1
COPD, chronic obstructive pulmonary disease; FF, fl uticasone furoate; ICS, inhaled corticosteroids; LABA, long- acting β2
-agonist; LAMA, long-acting muscarinic antagonist; OD, once-daily; UMEC, umeclidinium, VI, vilanterol.
References: 1. Trelegy Ellipta SmPC. 2. Lipson DA et al. Am J Respir Crit Care Med 2017; 196:438–446. 3. Svedsater H et al. BMC Pulm Med 2013; 13:72–86. 4. van der Palen J et al. NPJ Prim Care Respir Med 2016; 26:16079.
Trelegy Ellipta (fl uticasone furoate/umeclidinium/
vilanterol [as trifenatate]) Prescribing information
Please consult the full Summary of Product Characteristics (SmPC) before prescribing. Trelegy Ellipta (fl uticasone furoate/umeclidinium/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of fl uticasone furoate (FF) 100 micrograms (mcg), umeclidinium (UMEC) 62.5 micrograms and vilanterol (VI) 25 mcg provides a delivered dose of 92 mcg FF, 55 mcg UMEC and 22 mcg VI. Indications: Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting β2
-agonist (LABA).
Dosage and administration: One inhalation once daily. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate). Precautions: Paradoxical bronchospasm, unstable or life-threatening cardiovascular disease or heart rhythm abnormalities, convulsive disorders or thyrotoxicosis, pulmonary tuberculosis or patients with chronic or untreated infections, narrow-angle glaucoma, urinary retention, hypokalaemia, patients predisposed to low levels of serum potassium, diabetes mellitus. In patients with moderate to severe hepatic impairment patients should be monitored for systemic corticosteroid-related adverse reactions. Eye symptoms such as blurred vision may be due to underlying serious conditions such as cataract, glaucoma or central serous chorioretinopathy (CSCR); consider referral to ophthalmologist. Increased incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroids. Risk factors for pneumonia include: current smokers, older age, patients with a low body mass index and severe COPD. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase defi ciency or glucose-galactose malabsorption should not take Trelegy. Acute symptoms: Not for acute symptoms, use short-acting inhaled bronchodilator. Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases. Therapy should not be abruptly stopped without physician supervision due to risk of symptom recurrence. Systemic effects: Systemic effects of ICSs may occur, particularly at
high doses for long periods, but much less likely than with oral corticosteroids. Interactions with other medicinal products: Caution should be exercised during concurrent use of non-selective and selective beta-blockers and when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products), hypokalaemic treatments or non-potassium-sparing diuretics. Co-administration with other long-acting muscarinic antagonists or long acting β2
-adrenergic agonists has not
been studied and is not recommended. Pregnancy and breast-feeding: Experience limited. Balance risks against benefi ts. Side effects: Common (≥1/100 to <1/10): pneumonia, upper respiratory tract infection, pharyngitis, rhinitis, infl uenza, nasopharyngitis, headache, cough, arthralgia, back pain. Other important side effects include: Uncommon (≥1/1,000 to <1/100) supraventricular tachyarrhythmia, tachycardia, atrial fi brillation; Not known (cannot be estimated from the available data) vision blurred; See SmPC for other adverse reactions. Legal category: POM. Presentation and Basic NHS cost: Trelegy Ellipta 92/55/22 mcg - £44.50. 1 inhaler x 30 doses. Marketing authorisation (MA) nos. 92/55/22 mcg 1x30 doses [EU/1/17/1236/02]; MA holder: GSK Trading Services Ltd., Currabinny, Co. Cork Ireland. Last date of revision: November 2017. UK/TLY/0031/17. Trademarks are owned by or licensed to the GSK group of companies. 2017 GSK group of companies or its licensor Trelegy Ellipta was developed in collaboration with Innoviva Inc.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.
Trelegy Ellipta was developed in collaboration with Discover more at
www.trelegy.co.uk
A full list of adverse reactions for Trelegy Ellipta can be found in the Summary of Product Characteristics.
Trelegy and Ellipta are registered trademarks of the GlaxoSmithKline Group of Companies. © 2017 GlaxoSmithKline Group of Companies. All rights reserved.
Zinc code: UK/TLY/0035/17j | Date of preparation: March 2018
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