Relvar Ellipta Special Precautions

Deterioration of disease: Fluticasone furoate/vilanterol should not be used to treat acute asthma symptoms, 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.
Patients should not stop therapy with fluticasone furoate/vilanterol in asthma, without physician supervision since symptoms may recur after discontinuation.
Asthma-related adverse events and exacerbations may occur during treatment with fluticasone furoate/vilanterol. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of treatment with Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta).
Paradoxical bronchospasm: Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a short-acting inhaled bronchodilator. Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta). Therefore fluticasone furoate/vilanterol should be used with caution in patients with severe cardiovascular disease.
Systemic corticosteroid effects: 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).
Fluticasone furoate/vilanterol should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
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.
Pneumonia in patients with COPD: An increase in pneumonia has been observed in patients with COPD receiving fluticasone furoate/vilanterol. There was also an increased incidence of pneumonias resulting in hospitalisation. In some incidences these pneumonia events were fatal. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD receiving fluticasone furoate/vilanterol include current smokers, patients with a history of prior pneumonia, patients with a body mass index <25 kg/m² and patients with a (forced expiratory volume) FEV₁ <50% predicted. These factors should be considered when fluticasone furoate/vilanterol is prescribed and treatment should be re-evaluated if pneumonia occurs.
Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 200/25 micrograms is not indicated for patients with COPD. There is no additional benefit of the 200/25 micrograms dose compared to the 100/25 micrograms dose and there is a potential increased risk of systemic corticosteroid-related adverse reactions.
The incidence of pneumonia in patients with asthma was common at the higher dose. The incidence of pneumonia in patients with asthma taking fluticasone furoate/vilanterol 200/25 micrograms was numerically higher compared with those receiving fluticasone furoate/vilanterol 100/25 micrograms or placebo. No risk factors were identified.
Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the pharmacology of fluticasone furoate or vilanterol.
Patients with hepatic impairment: For patients with moderate to severe hepatic impairment, the 100/25 micrograms dose should be used and patients should be monitored for systemic corticosteroid-related adverse reactions.