ICS + LABA inhaler (once-daily) Pregnancy: §4.6: animal studies have shown reproductive toxicity at exposures not clinically relevant; there are no or limited data in pregnant women. 'Administration of fluticasone furoate/vilanterol to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.' Breast-feeding: insufficient information on excretion in human milk, though other corticosteroids and beta2-agonists are detected in human milk; a risk to breastfed newborns/infants cannot be excluded — decide whether to discontinue breast-feeding or therapy.

Fluticasone with vilanterol

Brand names: Relvar Ellipta

This once-daily dry-powder inhaler combines the inhaled corticosteroid fluticasone furoate with the long-acting beta2 agonist vilanterol (Relvar Ellipta), used as maintenance therapy for asthma and COPD.

Adult dose

Dose: Asthma, adults and adolescents aged 12 years and over: one inhalation of fluticasone furoate/vilanterol 92/22 micrograms as a starting dose for those requiring a low to mid dose of inhaled corticosteroid with a long-acting beta2-agonist; if inadequately controlled the dose can be increased to 184/22 micrograms. 184/22 micrograms should be considered from the outset for those requiring a higher inhaled corticosteroid dose

Route: Inhalation — 'for oral inhalation only', via the Ellipta dry powder inhaler; rinse mouth with water without swallowing after inhalation — source product: Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed

Frequency: Once daily, administered at the same time of day each day (evening or morning at the physician's discretion)

Max: §4.2 verbatim: 'The maximum recommended dose is Relvar Ellipta 184/22 micrograms once daily.' In moderate or severe hepatic impairment the maximum dose is 92/22 micrograms

SOURCE: eMC UK SPC, productName 'Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed' (https://www.medicines.org.uk/emc/product/5225/smpc), §4.2. INDICATION SCOPE OF THE FETCHED TEXT: the retrieved §4.2 contains an ASTHMA posology only — no COPD regimen appears in the fetched section (this is the 184/22 strength SPC). If this page also covers COPD, that regimen must be sourced separately from the 92/22 SPC; do not assume it. POTENCY NOTE (verbatim): 'in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone propionate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately equivalent to FP 500 micrograms twice daily.' TITRATION: patients should be regularly reassessed so the strength remains optimal, and 'the dose should be titrated to the lowest dose at which effective control of symptoms is maintained.' ONSET/CONTINUATION: improvement in lung function is usually experienced within 15 minutes, but regular daily use is necessary and should continue even when asymptomatic; a short-acting beta2-agonist should be used for symptoms arising between doses. MISSED DOSE: 'If a dose is missed the next dose should be taken at the usual time the next day.' PAEDIATRIC: no per-kg dose is stated, hence paedDose is null. §4.2 verbatim: 'The safety and efficacy of Relvar Ellipta in children under 12 years of age have not been established in the indication for asthma. Relvar Ellipta should not be used in children under 12 years of age.' ELDERLY: no dose adjustment in patients 65 years of age or older. STORAGE/HANDLING: if refrigerated, allow the inhaler to reach room temperature for at least an hour before use; write the 'Discard by' date (6 weeks from opening the tray) on the label. SECTIONS NOT RETRIEVED: §4.5 (interactions) was not included in the fetched bundle, so no interaction list is given here — clinician to review the SPC. Some sections of the product information we used were incomplete — check the full SPC.

Dose adjustments

Renal

§4.2: 'Renal impairment — No dose adjustment is required in this population.' (Hepatic impairment: caution, and for moderate or severe hepatic impairment the maximum dose is 92/22 micrograms.)

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (§4.3)
Not to be used to treat acute asthma symptoms, for which a short-acting bronchodilator is required (§4.4)
Should not be used in children under 12 years of age (§4.2)
Use with caution in severe cardiovascular disease or heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia or predisposition to low serum potassium, and in pulmonary tuberculosis or chronic/untreated infections (§4.4)

Side effects

Headache (very common) and nasopharyngitis (very common) — the most commonly reported reactions
Pneumonia, upper respiratory tract infection, bronchitis, influenza, candidiasis of mouth and throat (common) — pneumonia and fractures were more frequent in COPD patients
Oropharyngeal pain, abdominal pain, arthralgia, back pain, muscle spasms, fractures, pyrexia (common)
Extrasystoles (uncommon); palpitations and tachycardia (rare); hyperglycaemia and blurred vision (uncommon)
Rare: hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria; tremor; anxiety; sinusitis, pharyngitis, rhinitis, cough, dysphonia, paradoxical bronchospasm

Clinical monograph

How it works

Fluticasone furoate suppresses airway inflammation via glucocorticoid receptor activation, while vilanterol provides prolonged bronchodilation by stimulating airway beta2 adrenoceptors.

Prescribing in practice

In asthma the long-acting beta2 agonist must always be combined with the inhaled corticosteroid and never used alone, and this inhaler is not for relieving acute symptoms.
Inhaled corticosteroid exposure increases pneumonia risk in COPD and can cause oral candidiasis and hoarseness.
Beta2 agonist effects include tremor, palpitations and hypokalaemia, with caution in cardiovascular disease.

Monitoring

Monitor disease control and inhaler technique, watch for pneumonia in COPD, and review growth in children on long-term inhaled corticosteroid.

Counselling the patient

Use once daily as a preventer, not to treat sudden attacks.
Rinse the mouth after each dose to limit thrush and hoarseness.
Always keep a reliever inhaler available and report deterioration.

Evidence & guidelines

An established once-daily inhaled corticosteroid/long-acting beta2 agonist combination supported by asthma and COPD trial evidence and reflected in UK respiratory guidance.

Reference: NICE NG115/NG80; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways