The European Commission has approved a label update for the use of once-daily Relvar Ellipta ( Fluticasone furoate / Vilanterol, FF/VI ), an inhaled corticosteroid ( ICS ) / long-acting beta2-agonist ( LABA ) combination, in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting beta2-agonist.
The type II variation regulatory approval has been supported by data from a non-inferiority lung function study, which has demonstrated that patients with adequately controlled asthma were able to switch to the once-daily FF/VI 100/25, from the twice-daily Seretide Accuhaler ( Fluticasone propionate / Salmeterol, FP/SAL ) 250/50, without compromising their lung function.
No new safety signals were identified and the adverse event data were consistent with the known safety profile for FF/VI established in patients with asthma.
Relvar Ellipta is a once-daily dual combination treatment comprising Fluticasone furoate, an inhaled corticosteroid and Vilanterol, a long-acting beta2-agonist, in a single inhaler, the Ellipta.
Relvar Ellipta is indicated in European Union for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product ( long-acting beta2–agonist, and inhaled corticosteroid ) is appropriate: patients not adequately controlled with inhaled corticosteroids and as-needed inhaled short acting beta2-agonists; patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.
FF/VI is contraindicated in patients with hypersensitivity to either Fluticasone furoate, Vilanterol, or any of the excipients.
FF/VI should not be used to treat acute asthma symptoms or an acute exacerbation in COPD, for which a short-acting bronchodilator is required. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
Asthma-related adverse events and exacerbations may occur during treatment with FF/VI.
Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a short-acting inhaled bronchodilator. FF/VI should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including FF/VI. Therefore Fluticasone furoate / Vilanterol should be used with caution in patients with severe cardiovascular disease.
For patients with moderate to severe hepatic impairment, the 92/22 mcg dose should be used and patients should be monitored for systemic corticosteroid-related adverse reactions.
FF/VI 184/22 mcg is not indicated for patients with COPD. There is no additional benefit of the 184/22 mcg dose compared to the 92/22 mcg dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions.
An increase in the incidence of pneumonia has been observed in subjects with COPD receiving FF/VI. There was also an increased incidence of pneumonias resulting in hospitalisation. In some instances these pneumonia events were fatal.
The incidence of pneumonia in patients with asthma was common at the higher dose. In a previous study of FF/VI in asthma the incidence of pneumonia in patients with asthma taking FF/VI 184/22 mcg was numerically higher compared with those receiving FF/VI 92/22 mcg or placebo.
Hyperglycaemia: there have been reports of increases in blood glucose levels in diabetic patients and this should be considered when prescribing to patients with a history of diabetes mellitus.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur 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, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression ( particularly in children ).
FF/VI should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with FF/VI.
Very common adverse reactions ( occurring in more than 1/10 patients ) with FF/VI were headache and nasopharyngitis. Common adverse reactions ( occurring in more than 1/100 to less than 1/10 patients ) were pneumonia, upper respiratory tract infection, bronchitis, influenza, candidiasis of mouth and throat, oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia, abdominal pain, arthralgia, back pain, fractures, and pyrexia and muscle spasms.
Extrasystoles were observed as an uncommon adverse reaction ( occurring in more than 1/1,000 to less than 1/100 patients ).
Rare adverse reactions ( occurring in more than 1/10,000 to less than 1/1,000 ) were hypersensitivity reactions ( including anaphylaxis, angioedema, rash and urticaria ), anxiety, tremor, palpitations, tachycardia and paradoxical bronchospasm.
With the exception of pneumonia and fractures, the safety profile was similar in patients with asthma and COPD. During clinical studies, pneumonia and fractures were more frequently observed in patients with COPD. ( Xagena )
Source: GlaxoSmithKline, 2018