Trelegy Ellipta Special Precautions

The use of Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) has not been studied in patients with asthma and is not recommended in this patient population.
Exacerbations: Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) is intended for the maintenance treatment of COPD. It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting bronchodilator.
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 + Umeclidinium + Vilanterol (Trelegy Ellipta) without physician supervision since symptoms may recur after discontinuation.
Paradoxical bronchospasm: As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing and may be life-threatening. Treatment with Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists or sympathomimetic agents, including umeclidinium or vilanterol, respectively. Therefore, Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) should be used with caution in patients with unstable or life-threatening cardiovascular disease.
Patients with hepatic impairment: Patients with moderate to severe hepatic impairment receiving Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) should be monitored for systemic corticosteroid-related adverse reactions (see Pharmacology: Pharmacokinetics: Special Patient Populations 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 hypothalamic‐pituitary‐adrenal (HPA) suppression, decrease in bone mineral density, cataract, glaucoma, and central serous chorioretinopathy (CSCR).
As with all medication containing corticosteroids, Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections.
Antimuscarinic activity: Consistent with its antimuscarinic activity, Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Pneumonia: In line with the known class effect of inhaled corticosteroids, pneumonia events (including pneumonias resulting in hospitalisation) were observed in patients with COPD receiving Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta). In some instances, fatal events of pneumonia have been reported with use of inhaled corticosteroid fluticasone furoate-containing drugs, including Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) (see 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 inhaled corticosteroid-containing drugs include current smokers, patients with a history of prior pneumonia, patients with low body mass index and patients with severe COPD. These factors should be considered when Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) is prescribed, and treatment should be re-evaluated if pneumonia occurs.
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of Fluticasone furoate + Umeclidinium + Vilanterol (Trelegy Ellipta) on the ability to perform tasks that require judgement, motor or cognitive skills.
A detrimental effect on such activities would not be anticipated from the pharmacology of fluticasone furoate, umeclidinium or vilanterol at clinical doses.