Pulse February 2019 issue - Page 17

RELVAR ELLIPTA (fluticasone furoate/vilanterol) Relvar Ellipta was superior to other ICS/LABAs (usual care) in helping more patients improve asthma control in everyday clinical practice in the Salford Lung Study. 1 The most commonly used ICS/LABAs were: Seretide (fluticasone propionate/salmeterol), Symbicort, Fostair. 2 Data presented are from a subset of patients in the PEA population prescribed ICS/LABA at randomisation. 1 Read the clinical data at relvarhcp.co.uk PEA, primary effectiveness analysis. References: 1. Woodcock A et al. Lancet. 2017;390(10109):2247–2255. 2. GSK DoF RF/FFT/0019/18. Prescribing information Please consult the full Summary of Product Characteristics (SmPC) before prescribing. Relvar Ellipta (fluticasone furoate/vilanterol [as trifenatate]) inhalation powder. Each single inhalation of fluticasone furoate (FF) 100 micrograms (mcg) and vilanterol (VI) 25 mcg provides a delivered dose of 92 mcg FF and 22 mcg VI. Each single inhalation of FF 200 mcg and VI 25 mcg provides a delivered dose of 184 mcg of FF and 22 mcg of VI. Indications: Asthma: Regular treatment of asthma in patients ≥12 years where a long-acting β 2 -agonist (LABA) and inhaled corticosteroid (ICS) combination is appropriate; i.e. patients not adequately controlled on ICS and ‘’as needed” short-acting inhaled β 2 -agonists or patients already adequately controlled on both ICS and LABA. COPD: Symptomatic treatment of adults with COPD with a FEV 1 <70% predicted normal (post- bronchodilator) and an exacerbation history despite regular bronchodilator therapy. Dosage and administration: Inhalation only. Asthma: Adults and adolescents ≥12 years: one inhalation once daily of Relvar 92/22 mcg for patients who require a low to mid dose of ICS in combination with a LABA. If patients are inadequately controlled then the dose can be increased to one inhalation once daily Relvar 184/22 mcg. Relvar 184/22 mcg can also be considered for patients who require a higher dose of ICS in combination with a LABA. Regularly review patients and reduce dose to lowest that maintains effective symptom control. COPD: one inhalation once daily of Relvar 92/22 mcg. Relvar 184/22 mcg is not indicated for patients with COPD. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate & magnesium stearate). Precautions: Pulmonary tuberculosis, severe cardiovascular disorders or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia, patients predisposed to low levels of serum potassium, chronic or untreated infections, diabetes mellitus, paradoxical bronchospasm. In patients with moderate to severe hepatic impairment 92/22 mcg dose should be used. 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. Asthma- related adverse events and exacerbations may occur during treatment. Patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Relvar. Systemic effects: Systemic effects of ICSs may occur, particularly at high doses for long periods, but much less likely than with oral corticosteroids. Possible Systemic effects include: Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents. 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. More rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Increased incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroids. Risk factors for pneumonia include: current smokers, old age, patients with a history of prior pneumonia, patients with a body mass index <25 kg/m2 and patients with a FEV 1 <50% predicted. If pneumonia occurs with Relvar treatment should be re-evaluated. Patients with 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 rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Relvar. Interactions with other medicinal products: Interaction studies have only been performed in adults. Avoid β-blockers. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products). Concomitant administration of other sympathomimetic medicinal products may potentiate the adverse reactions of FF/ VI. Relvar should not be used in conjunction with other long- acting β 2 -adrenergic agonists or medicinal products containing long-acting β 2 -adrenergic agonists. Pregnancy and breast- feeding: Experience limited. Balance risks against benefits. Side effects: Very Common (≥1/10): headache, nasopharyngitis. Common (≥1/100 to <1/10): candidiasis of the mouth and throat, dysphonia, pneumonia, bronchitis, upper respiratory tract infection, influenza, oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, abdominal pain, arthralgia, back pain, fractures, pyrexia, muscle spasms. Other important side effects include: Uncommon (≥1/1,000 to <1/100); blurred vision, hyperglycaemia. Rare (≥1/10,000 to <1/1,000) paradoxical bronchospasm and hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria. See SmPC for other adverse reactions. Legal category: POM. Presentation and Basic NHS cost: Relvar Ellipta. 1 inhaler x 30 doses. Relvar Ellipta 92/22 - £22.00. Relvar Ellipta 184/22 - £29.50. Marketing authorisation (MA) nos. 92/22 mcg 1x30 doses [EU/1/13/886/002]; 184/22 mcg 1x30 doses [EU/1/13/886/005]. MA holder: Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, UK. Last date of revision: September 2018. UK/FFT/0227/15(6). Trademarks are owned by or licensed to the GSK group of companies. © 2018 GSK group of companies or its licensor. Relvar Ellipta was developed in collaboration with Innoviva Inc. © 2018 GlaxoSmithKline Group of Companies. Zinc code: UK/FFT/0054/18a Date of preparation: September 2018