Fluticasone and vilanterol

Reviewed U.S. Breo Ellipta is indicated for maintenance treatment of COPD and for maintenance treatment of asthma from age 5. The dose strength depends on indication and age; pediatric asthma approval does not authorize every strength in every child. It is not indicated for relief of acute bronchospasm.

Do not begin Breo during rapidly deteriorating or potentially life-threatening asthma/COPD. Acute symptoms require the prescribed short-acting rescue treatment and escalation plan; rising rescue use or loss of response needs immediate clinical reassessment. The labeled early bronchodilator response does not establish a reliever regimen. Additional Breo doses or another LABA are not an appropriate rescue strategy.

This profile covers the two-ingredient fluticasone furoate/vilanterol Ellipta dry-powder inhaler. Fluticasone propionate/salmeterol, fluticasone alone, and fluticasone/umeclidinium/vilanterol triple therapy have different ingredient and dose rules. No universal inhaled-steroid equivalence, combination-device conversion or off-label acute regimen is supplied.

The first amount is fluticasone furoate; the second is vilanterol. Each row uses one inhalation once daily, with no more than one dose in 24 hours. Adult asthma strength selection depends on disease severity, prior treatment and current control; inadequately controlled asthma on 100/25 mcg may warrant a clinician increase to 200/25 mcg. If 200/25 mcg remains inadequate, reassess rather than add extra inhalations. COPD dose must not be increased above its 100/25 mcg schedule.

Open the cover only when ready; a click and counter decrement prepare one dose. Do not shake. Breathe out away from the inhaler, seal lips around the mouthpiece without blocking the vent, and take one long, steady, deep breath through the mouth. Hold about 3–4 seconds or as comfortable, then exhale slowly. Close the cover and rinse the mouth with water, spitting it out. Not tasting powder is not a reason to repeat a dose. Opening/closing without inhalation wastes that prepared dose.

Patient instructions say to take a missed dose when remembered, without taking more than one inhalation per day; take the next dose at the usual time and never two doses together. Follow the prescribed plan, check the counter and obtain a refill before it empties. Do not disassemble the nonreusable inhaler or substitute nebulization, an injection or swallowing the powder for its oral-inhalation route.

No renal dose adjustment is required in the reviewed label. Moderate/severe hepatic impairment warrants caution and monitoring for systemic corticosteroid effects; no U.S. label numeric hepatic dose-reduction algorithm is supplied. Pediatric hepatic PK is unevaluated. A transfer from oral/systemic corticosteroids requires a supervised gradual withdrawal and stress plan; inhaled Breo cannot replace systemic glucocorticoid coverage during adrenal insufficiency.

Primary treatment of status asthmaticus or acute COPD/asthma episodes needing intensive measures is contraindicated. Severe milk-protein hypersensitivity and demonstrated hypersensitivity to fluticasone furoate, vilanterol or excipients are also contraindications. Lactose carrier contains milk proteins; this warning concerns protein allergy and should not be automatically equated with ordinary lactose intolerance.

No formal boxed warning appears in the current reviewed Breo label. LABA monotherapy in asthma increases serious asthma-event risk; Breo instead includes an ICS and LABA together. Fixed ICS/LABA safety trials did not show a significant increase versus ICS alone under their trial conditions, but they did not exclude all risk. Do not describe historical LABA warnings as a current Breo boxed warning or promise zero asthma risk.

Reported common events include nasopharyngitis, respiratory infections, headache and oral candidiasis; dysphonia and throat pain are notable in asthma, while pneumonia is important in COPD. Pediatric reports include upper respiratory symptoms and headache. Serious/postmarketing concerns include anaphylaxis, paradoxical bronchospasm, tachycardia, tremor and hyperglycemia. Rates vary by indication, age and trial and are not interchangeable individual-risk estimates.

Ketoconazole and other strong inhibitors such as ritonavir, clarithromycin and itraconazole can increase fluticasone furoate/vilanterol systemic exposure, with greater corticosteroid or cardiovascular toxicity. The label calls for caution and clinical review, not an invented universally safe reduced inhalation schedule. Monitor for adrenal and cardiovascular effects when coadministration is necessary.

Do not add another LABA-containing therapy. MAO inhibitors, tricyclic antidepressants and QT-prolonging drugs require extreme caution during use and within 2 weeks of discontinuation because cardiovascular beta-agonist effects can be potentiated. An emergency/rescue plan should be prescribed separately rather than achieved by extra vilanterol exposure.

Beta-blockers can blunt bronchodilation and cause severe bronchospasm; if a compelling indication leaves no alternative, a cardioselective agent may be considered with caution and supervision. Loop/thiazide diuretics can compound ECG changes or hypokalemia, particularly with beta-agonist overuse. Review symptoms and relevant potassium/ECG monitoring by risk rather than require a fixed testing schedule for everyone.

Asthma safety/effectiveness are established from age 5 using 50/25 mcg at 5–11 and 100/25 mcg at 12–17; use under age 5 is not established. Monitor growth routinely and use the lowest effective appropriate regimen. No geriatric adjustment is needed solely for age in the label, although increased individual sensitivity and comorbidities remain possible.

The U.S. label requires no renal dose adjustment, including its studied severe-impairment group. Hepatic impairment can increase systemic fluticasone furoate exposure; use cautiously in moderate/severe impairment and monitor corticosteroid effects. The adult studies do not establish a pediatric hepatic dose algorithm or license exceeding age-specific strengths.

Human data for the combination/components are insufficient to characterize pregnancy risk; poorly controlled maternal asthma itself has adverse perinatal consequences, so maintain individualized control and monitoring. During late gestation/labor, weigh benefit against beta-agonist interference with uterine contractility. The reviewed PI reports no direct human-milk or infant-effect data for these components, although other ICS can appear at low milk concentrations; balance breastfeeding benefits, maternal need and potential infant effects. Animal findings do not prove human safety.

Fluticasone furoate is a glucocorticoid with anti-inflammatory actions across airway cells and mediators. Vilanterol stimulates beta 2 receptors and intracellular cyclic AMP to relax bronchial smooth muscle. Beta 2 receptors outside the airway permit cardiovascular/metabolic effects despite relative selectivity. In-vitro receptor-affinity comparisons do not establish clinical dose equivalence with other corticosteroids.

Systemic exposure mainly arises from the portion inhaled into the lung; swallowed portions have low oral bioavailability because of first-pass metabolism. Fluticasone furoate and vilanterol are mainly metabolized through CYP3A4 and are highly protein bound. Repeated-dose fluticasone furoate plasma half-life averages about 24 hours; vilanterol is about 21 hours in COPD and 16 hours in asthma. Actual lung delivery depends on inspiratory technique/flow, and plasma levels do not predict therapeutic response reliably.

Assess symptoms, exacerbations, rescue frequency, lung function where appropriate, adherence and inhalation technique. Inspect for thrush, assess pneumonia symptoms in COPD, monitor pediatric growth, and consider eye assessment with symptoms or prolonged use. COPD labeling recommends baseline/periodic bone-density assessment. Monitor systemic corticosteroid effects especially with hepatic impairment, strong CYP3A4 inhibition or oral-steroid transfer; potassium/glucose/ECG assessment is risk-based.

Use one scheduled inhalation, rinse/spit, never add a second LABA, and keep the prescribed rescue inhaler available. Obtain urgent assessment if rescue becomes less effective, use increases, or breathing worsens; severe breathing difficulty, chest pain or anaphylaxis requires emergency care. Do not abruptly change maintenance or systemic steroid therapy without guidance. Suspected excess dosing with tachycardia, chest pain, shakiness or worsening breathlessness needs urgent/poison-center assessment.

The selected light-grey/pale-blue disposable Ellipta device is packaged in a moisture-protective foil tray with desiccant. Representative 30-dose NDCs are 0173-0916-10 for 50/25 mcg, 0173-0859-10 for 100/25 mcg and 0173-0882-10 for 200/25 mcg; selected institutional packs contain 14 doses. Package listing is not real-time stock confirmation, and the desiccant must not be eaten or inhaled.

Nominal labeled oral-inhalation strengths are fluticasone furoate/vilanterol 50/25, 100/25 and 200/25 mcg per actuation. Standardized in-vitro mouthpiece delivery is lower than blister content and differs from actual lung delivery; do not replace labeled dosing with a reconstructed delivered-dose conversion. The lactose carrier contains milk proteins; vilanterol is supplied as its trifenatate salt.

Store at 20–25°C (68–77°F), with allowed excursions 15–30°C; keep dry, away from direct heat/sunlight. Leave the unopened moisture-protective tray sealed until first use. Discard 6 weeks after opening the tray or when the counter reaches zero, whichever comes first; date the label. Do not disassemble or reuse the device. A dry tissue may clean the mouthpiece if needed; routine cleaning is not required.