Relvar Ellipta Special Precautions

Exacerbations: RELVAR ELLIPTA 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.
Patients should not stop therapy with RELVAR ELLIPTA, in asthma or COPD, without physician supervision since symptoms may recur after discontinuation.
Asthma-related adverse events and exacerbations may occur during treatment with RELVAR ELLIPTA. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of RELVAR ELLIPTA.
Paradoxical Bronchospasm: As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a short-acting inhaled bronchodilator. 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 drugs, including RELVAR ELLIPTA. Therefore RELVAR ELLIPTA should be used with caution in patients with severe cardiovascular disease.
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 (see Pharmacology: Pharmacokinetics under Actions).
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, HPA axis suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma.
As with all medication containing corticosteroids, RELVAR ELLIPTA should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Pneumonia: An increase in pneumonia has been observed in patients with COPD receiving RELVAR ELLIPTA. There was also an increased incidence of pneumonias resulting in hospitalisation. In some incidences these pneumonia events were fatal (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions and Adverse Reactions). 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 RELVAR ELLIPTA 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.
The incidence of pneumonia in patients with asthma was uncommon. Patients with asthma taking fluticasone furoate/vilanterol 200/25 micrograms may be at an increased risk of pneumonia compared with those receiving fluticasone furoate/vilanterol 100/25 or placebo. No risk factors were identified.
Effects on the Ability to Drive or Operate Machinery: There have been no studies to investigate the effect of 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.
Impairment of Fertility: There are no fertility data in humans. Animal studies showed no effect of vilanterol or fluticasone furoate on fertility (see Pharmacology: Toxicology: Pre-Clinical Safety Data under Actions).