Fluticasone furoate / umeclidinium / vilanterol

COPD maintenance treatment uses the 100/62.5/25 mcg strength. Asthma maintenance is indicated in patients aged 18 years and older, with 100 or 200 mcg fluticasone options. It is not indicated for acute bronchospasm, and pediatric safety/effectiveness through age 17 have not been established.

The three ingredients combine anti-inflammatory and bronchodilator actions. A prescriber must assess maintenance control, previous inhaled steroid exposure and exacerbation risk when selecting therapy; shared ingredients do not justify automatically switching other inhalers or using Trelegy as a reliever.

Open the cover fully only when ready; the click loads one dose and the counter decreases. No shaking or priming is needed. Breathe out fully away from the device; seal lips around the mouthpiece without blocking the vent, inhale one long, steady, deep breath through the mouth, and hold about 3–4 seconds or as comfortable. Exhale slowly away, close the cover, then rinse the mouth with water and spit without swallowing. Do not repeat because no taste is felt. Opening/closing without inhaling wastes that dose; it cannot later be recovered.

Have the prescribed short-acting beta2-agonist available for acute symptoms. Do not use extra Trelegy or another LABA. At initiation, scheduled short-acting beta2-agonist use is changed to symptom relief under the prescriber’s plan. Transfer from systemic corticosteroids requires supervised gradual taper and assessment of adrenal recovery; Trelegy does not supply systemic steroid coverage during stress, surgery or severe illness.

Primary treatment of status asthmaticus or other acute COPD/asthma episodes requiring intensive measures; severe hypersensitivity to milk proteins or any active ingredient/excipient. The powder contains lactose with milk proteins: severe milk-protein allergy is distinct from lactose intolerance.

The selected current Trelegy label has no boxed warning. LABA monotherapy without inhaled corticosteroid increases serious asthma-related events; Trelegy includes an ICS. Controlled ICS/LABA trial data did not show a significant increase versus ICS alone, but Trelegy still requires appropriate maintenance and rescue use.

Trial reports include upper respiratory/pharyngeal infection, headache, back pain, cough, dysphonia, oral candidiasis and other GI/musculoskeletal symptoms; pneumonia is an important COPD risk. Postmarketing reports include palpitations, eye effects, allergy, tremor, anxiety, hyperglycemia and urinary retention. Overdose may produce severe beta-agonist cardiovascular/metabolic toxicity, anticholinergic effects or chronic steroid excess. Stop excess dosing, obtain urgent medical/Poison Help advice and use clinician-directed supportive care and cardiac monitoring.

Strong CYP3A4 inhibitors such as ketoconazole or ritonavir can increase fluticasone/vilanterol exposure and steroid/cardiovascular adverse effects; use caution and monitor. Use extreme caution with MAO inhibitors, tricyclic antidepressants or QT-prolonging drugs, including within 2 weeks of their discontinuation, because vilanterol cardiovascular effects may be enhanced.

Avoid another LABA and other anticholinergic-containing medicines because of overdose/additive effects. Beta-blockers can antagonize bronchodilation and produce severe bronchospasm; when no suitable alternative exists, a clinician may cautiously consider a cardioselective agent. Non-potassium-sparing diuretics can amplify hypokalemia/ECG changes, particularly with excessive beta-agonist doses; monitor risk rather than automatically supplementing potassium.

No renal or age-only geriatric adjustment is required in the label; some older patients may be more sensitive. The triple product itself has not been studied in renal/hepatic impairment; component studies inform the advice. Use caution and monitor steroid effects in moderate/severe hepatic impairment; fluticasone exposure rises. Severe hepatic umeclidinium studies are lacking.

Human pregnancy data are insufficient to define drug-associated risk. Poorly controlled maternal asthma itself harms maternal/perinatal outcomes; monitor and adjust for disease control. In late gestation/labor, use only when benefit justifies possible beta-agonist interference with uterine contractions. Human milk transfer, infant effects and milk-production data are unavailable; consider breastfeeding benefits, maternal need and potential infant risks.

Safety/effectiveness are not established at age 17 or younger; Trelegy is not indicated in pediatric patients. Inhaled corticosteroids can reduce growth velocity, but evidence from other fluticasone formulations does not supply a Trelegy pediatric regimen.

Fluticasone furoate is a glucocorticoid with broad anti-inflammatory effects. Umeclidinium blocks airway muscarinic receptors, including M 3-mediated smooth-muscle constriction. Vilanterol stimulates beta2 receptors and increases cyclic AMP to relax bronchial smooth muscle; cardiac beta receptors help explain systemic effects.

Absorption

Inhaled fluticasone peak 0.5–1 hour; umeclidinium/vilanterol peaks 5–15 minutes in healthy subjects. Plasma levels do not directly predict clinical effect.

Metabolism

Fluticasone and vilanterol mainly CYP3A4; umeclidinium mainly CYP2D6 in vitro. Components are P-gp substrates.

Elimination

Fluticasone repeat-inhaled half-life averages 24 hours; predominantly fecal radiolabel recovery. Vilanterol effective repeated-inhalation half-life 11 hours. Umeclidinium biliary/fecal and urinary elimination; no route-transplanted half-life is supplied.

Clinical limitation

Full product interaction/renal/hepatic studies are limited; several findings come from components or dual combinations.

Assess symptoms, exacerbations, lung function, rescue response/use and observed inhaler technique. Check thrush, pneumonia/infection symptoms, steroid withdrawal/adrenal signs, cardiovascular effects and retention/ocular symptoms. Assess BMD at baseline and periodically in COPD and consider eye evaluation with symptoms or long-term use. Glucose/potassium assessment follows diabetes, interacting diuretics or toxicity risk; no universal routine laboratory interval is inferred.

Maintain rescue access and a written deterioration plan. Do not stop maintenance treatment without provider advice. Rinse/spit after dosing and keep the device dry; optional mouthpiece cleaning uses a dry tissue, with no routine washing. A counter that fails to decrease at the click needs pharmacist/provider help. Refill when fewer than 10 doses remain (red half-counter); do not use at 0. Record tray-open and 6-week discard dates. Avoid exposing the powder to eyes, children or moisture.

Ingredients / route

Fluticasone furoate 100 mcg / umeclidinium 62.5 mcg / vilanterol 25 mcg · oral inhalation powder.

Appearance / manufacturer

Light gray/beige disposable Ellipta · GSK.

Example NDC

0173-0887-10 ·30 inhalations,60 blisters.

Status

Prescription U.S. NDA product; labeled COPD and adult asthma maintenance.

Labeled strengths

100/62.5/25 and 200/62.5/25 mcg. The 200 strength is asthma-only in this label.

Pack distinction

30 inhalations;14-inhalation institutional pack.200 strength example 30-dose NDC 0173-0893-10. Two strips have one blister each opened for a dose.

Nominal vs delivered dose

Label strengths describe blister ingredient amounts. Standard in-vitro mouthpiece delivery is 92 or 184 mcg fluticasone /55 mcg umeclidinium /22 mcg vilanterol; actual lung delivery depends on patient inhalation. Do not convert the prescribed strength from this test.

Excipients

Lactose monohydrate contains milk proteins; magnesium stearate is also present. No nebulized, nasal or injectable triple formulation is inferred.

Store 20–25°C (excursions 15–30°C), dry and away from direct heat/sunlight. Leave sealed in moisture-protective foil tray until first use; discard desiccant safely. Discard 6 weeks after tray opening or at counter 0, whichever comes first. Device is not reusable; do not disassemble. Keep away from children.