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Pharmaceutical Facts on Trelegy Ellipta

Category	Details
Generic Name	Fluticasone furoate, Umeclidinium, Vilanterol
Brand Name	Trelegy Ellipta
Drug Class	Inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and long-acting beta agonist (LABA)
Indication	Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Other Indications	Maintenance treatment of asthma in adults aged 18 years and older
Formulation	Inhalation powder, delivered via the Ellipta inhaler
Common Dosages	100 mcg/62.5 mcg/25 mcg; 200 mcg/62.5 mcg/25 mcg
Mechanism of Action	– Fluticasone furoate: Anti-inflammatory effect via glucocorticoid receptor activation
	– Umeclidinium: Inhibits muscarinic receptors in the airways, leading to bronchodilation
	– Vilanterol: Stimulates beta-2 adrenergic receptors, causing bronchodilation
Pharmacokinetics	– Absorption: Inhaled with minimal systemic absorption
	– Half-life: Fluticasone furoate (~24 hours), Umeclidinium (~11 hours), Vilanterol (~21 hours)
	– Metabolism: Primarily hepatic via CYP3A4
	– Excretion: Fluticasone furoate (primarily feces), Umeclidinium (primarily feces), Vilanterol (urine and feces)
Administration	– Inhalation via the Ellipta device, once daily
	– Rinse mouth with water after use to reduce the risk of oral thrush
Common Side Effects	– Upper respiratory tract infections
	– Headache
	– Back pain
	– Dysphonia (hoarseness)
	– Oral candidiasis (thrush)
Serious Side Effects	– Pneumonia
	– Increased risk of cardiovascular events
	– Paradoxical bronchospasm
	– Hypersensitivity reactions (angioedema, rash)
	– Decrease in bone mineral density (long-term use)
Contraindications	– Severe hypersensitivity to milk proteins or any component of Trelegy Ellipta
	– Primary treatment of status asthmaticus or acute episodes of COPD/asthma requiring intensive measures
Special Populations	– Elderly: No dose adjustment necessary, but greater sensitivity in some individuals
	– Renal Impairment: No dose adjustment required
	– Hepatic Impairment: Use with caution in moderate to severe impairment
	– Pediatrics: Safety and efficacy not established for COPD; approved for asthma in patients aged 18 years and older
Monitoring	– Regular monitoring of lung function (FEV1)
	– Monitor for signs of HPA axis suppression
	– Monitor for signs and symptoms of infection
	– Periodic bone mineral density assessments in patients with risk factors for osteoporosis
Pregnancy Category	Not assigned (use only if the potential benefit justifies the potential risk to the fetus)
Lactation	It is unknown if the components are excreted in human milk; consider the benefits and risks of use during breastfeeding
Drug Interactions	– CYP3A4 inhibitors: Increased risk of systemic corticosteroid effects (e.g., ketoconazole, itraconazole)
	– Beta-blockers: May reduce the effectiveness of Vilanterol
	– Diuretics: Increased risk of hypokalemia
	– MAO inhibitors, tricyclic antidepressants: Increased risk of cardiovascular effects
Overdose Management	– Symptomatic and supportive treatment
	– Beta-agonist overdose: Cardiac monitoring may be necessary
	– Corticosteroid overdose: Monitor for signs of hypercorticism
Special Precautions	– Paradoxical Bronchospasm: May cause life-threatening bronchospasm; discontinue immediately if occurs
	– Immunosuppression: May increase susceptibility to infections
	– Ocular Effects: Risk of glaucoma and cataracts with long-term use
	– Adrenal Suppression: Long-term use may result in adrenal insufficiency
	– Growth Suppression: Potential for growth reduction in pediatric patients (although not applicable to COPD treatment)
Storage	– Store at room temperature (20-25°C or 68-77°F)
	– Keep the inhaler in a dry place
	– Keep out of reach of children
Manufacturer	GlaxoSmithKline
Approval Year	2017 (COPD), 2020 (asthma)
Market Availability	Widely available in the US and internationally
Patent Expiry	Expected patent expiry in the US is 2031