Relvar

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Relvar on Prescriptsy

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Relvar Ellipta is a once-daily combination inhaler containing fluticasone furoate (an inhaled corticosteroid, or ICS) and vilanterol (a long-acting beta2-agonist, or LABA).

It is used as a preventer treatment for asthma in adults and adolescents aged 12 years and over, and for the symptomatic treatment of chronic obstructive pulmonary disease (COPD) in adults with a history of exacerbations.

Relvar is the first ICS/LABA combination inhaler designed specifically for once-daily use, offering improved adherence compared with twice-daily alternatives.

It is a prescription-only medicine (POM) in the United Kingdom, manufactured by GlaxoSmithKline (GSK).

Asthma and COPD are the two most common chronic respiratory diseases in the UK.

Asthma affects approximately 5.4 million people and is characterised by variable airflow obstruction, airway inflammation, and bronchial hyperresponsiveness.

COPD, which includes chronic bronchitis and emphysema, affects an estimated 1.2 million diagnosed individuals, with many more undiagnosed.

Both conditions require regular preventer medication to control symptoms, reduce exacerbations, and prevent long-term airway damage.

This page provides a comprehensive clinical guide to Relvar Ellipta, covering how it works, dosage instructions, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about Relvar Ellipta

Before reading further, please note these essential safety points.

• Relvar is a preventer inhaler and must not be used to relieve acute asthma attacks or sudden COPD symptoms. Always carry a separate reliever inhaler (such as salbutamol).
• Do not stop using Relvar suddenly without medical advice, even if you feel well. Stopping may cause your symptoms to worsen.
• Rinse your mouth with water and spit it out after each inhalation to reduce the risk of oral thrush and hoarseness.
• Patients with COPD using ICS-containing inhalers have a small increased risk of pneumonia. Report worsening cough, fever, or new breathlessness promptly.
• Patients with severe milk protein allergy should not use Relvar Ellipta.

Understanding asthma and COPD

Asthma is a chronic inflammatory disease of the airways characterised by episodic wheeze, breathlessness, chest tightness, and cough.

The underlying pathology involves eosinophilic airway inflammation, smooth muscle contraction (bronchospasm), mucus hypersecretion, and airway remodelling.

Triggers include allergens (house dust mites, pollen, pet dander), respiratory infections, exercise, cold air, and air pollution.

Treatment aims to control symptoms, prevent exacerbations, and maintain normal lung function using a stepwise approach as outlined in the BTS/SIGN British Guideline on the Management of Asthma and NICE guideline NG80.

COPD is a progressive condition characterised by persistent airflow limitation that is not fully reversible.

It is predominantly caused by smoking, although occupational exposures, alpha-1 antitrypsin deficiency, and biomass fuel exposure also contribute.

COPD includes chronic bronchitis (persistent productive cough) and emphysema (destruction of alveolar walls). Symptoms include progressive breathlessness, chronic cough, and sputum production.

COPD exacerbations, often triggered by respiratory infections, are associated with accelerated lung function decline, hospitalisation, and increased mortality. Management follows NICE guideline NG115 and the GOLD strategy report.

How Relvar Ellipta works

Relvar Ellipta combines two complementary mechanisms of action. Fluticasone furoate is a potent synthetic corticosteroid that suppresses the inflammatory cascade driving asthma and COPD.

It binds to intracellular glucocorticoid receptors in airway epithelial cells, inflammatory cells, and structural cells, switching off the transcription of pro-inflammatory genes and switching on anti-inflammatory genes.

This reduces the production of cytokines (such as IL-4, IL-5, and IL-13), chemokines, and adhesion molecules, leading to decreased eosinophil infiltration, reduced mucus production, and improved epithelial barrier integrity.

Fluticasone furoate has a particularly high affinity for the glucocorticoid receptor and a prolonged duration of receptor binding, which underpins its 24-hour efficacy.

Vilanterol is a selective long-acting beta2-adrenoceptor agonist that relaxes airway smooth muscle.

It binds to beta2-receptors on smooth muscle cells, activating the enzyme adenylyl cyclase, which increases intracellular cyclic adenosine monophosphate (cAMP).

Elevated cAMP activates protein kinase A, which phosphorylates proteins involved in smooth muscle contraction, resulting in bronchodilation.

Vilanterol has an onset of action within 15 minutes and a duration of at least 24 hours, making it suitable for once-daily dosing.

It also has effects on mucociliary clearance and may reduce vascular permeability in the airways.

The combination of ICS and LABA is well established in asthma and COPD management. The ICS addresses the inflammatory component, while the LABA provides sustained bronchodilation.

There is also evidence of pharmacological synergy: corticosteroids upregulate beta2-receptor expression (preventing tachyphylaxis to the LABA), while LABAs enhance the nuclear translocation of glucocorticoid receptors (improving corticosteroid responsiveness).

Clinical evidence for Relvar Ellipta

The efficacy of Relvar Ellipta in asthma was demonstrated in several large randomised controlled trials, including the Phase III studies by Bleecker et al. and Woodcock et al.

These showed significant improvements in lung function (FEV1), symptom control, and rescue-free days compared with fluticasone furoate alone.

The once-daily regimen achieved similar or superior asthma control compared with twice-daily fluticasone propionate/salmeterol (Seretide), with the potential for improved adherence due to the simpler dosing schedule.

In COPD, the landmark SUMMIT trial (Study to Understand Mortality and Morbidity in COPD) enrolled over 16,000 patients and evaluated the effect of Relvar Ellipta 92/22 on all-cause mortality.

While the primary endpoint (mortality reduction) did not reach statistical significance, the study demonstrated significant reductions in the rate of moderate and severe exacerbations and improvements in lung function.

The Salford Lung Study, a pragmatic real-world effectiveness trial conducted in the NHS, showed that Relvar Ellipta improved asthma control and reduced severe exacerbation rates in everyday clinical practice compared with existing ICS or ICS/LABA regimens.

Relvar Ellipta compared with other ICS/LABA inhalers

Several ICS/LABA combination inhalers are available in the UK. Seretide (fluticasone propionate/salmeterol) and Symbicort (budesonide/formoterol) are established twice-daily options.

Fostair (beclometasone/formoterol) is another twice-daily combination available as a pressurised metered-dose inhaler (pMDI) and dry-powder inhaler. DuoResp Spiromax (budesonide/formoterol) is a generic alternative to Symbicort.

The key advantage of Relvar Ellipta is its once-daily dosing, which may improve adherence.

The Ellipta device itself is also designed for simplicity: it requires only opening the cover, inhaling, and closing the cover, with a built-in dose counter.

NICE technology appraisal guidance supports the use of ICS/LABA combinations for patients whose asthma is not adequately controlled on ICS alone (BTS/SIGN Step 3 and above).

For COPD, NICE NG115 recommends ICS/LABA combinations for patients with asthmatic features or eosinophilic inflammation who continue to exacerbate on LABA/LAMA therapy.

The Ellipta inhaler device

The Ellipta is a dry-powder inhaler that delivers medication as a fine powder activated by the patient's inhalation.

To use it, slide open the cover to expose the mouthpiece (this loads the dose and advances the counter), breathe out gently away from the device, place the mouthpiece between the lips, and breathe in steadily and deeply.

Hold the breath for 3 to 4 seconds, then breathe out slowly. Close the cover after use.

Each device contains 30 doses and has a dose counter on the front. When the counter reaches zero, the device is empty and should be replaced.

Do not wash the Ellipta device or take it apart. It can be kept clean by wiping the mouthpiece with a dry tissue.

If you are unsure about your inhaler technique, ask your GP, pharmacist, or asthma nurse for a demonstration. Correct technique is essential for effective drug delivery.

Dosage and administration

Relvar Ellipta is taken as one inhalation once daily at the same time each day. For asthma, the starting dose is usually Relvar 92/22.

If asthma control is not achieved after at least 4 weeks, the prescriber may step up to Relvar 184/22. For COPD, only the 92/22 strength is licensed.

Rinse your mouth with water and spit it out after each inhalation. Continue using Relvar every day, even when you feel well, to maintain control of your condition.

Side effects of Relvar Ellipta

Common side effects

Headache, nasopharyngitis, and upper respiratory tract infection are the most commonly reported side effects.

Oral candidiasis (thrush) occurs in approximately 5% to 7% of users and presents as white patches or soreness in the mouth.

Rinsing the mouth after inhalation significantly reduces this risk.

Dysphonia (hoarseness) is related to local deposition of corticosteroid on the vocal cords and affects approximately 3% to 5% of users.

Pneumonia risk in COPD

Patients with COPD using ICS-containing inhalers have an increased risk of developing pneumonia.

The SUMMIT trial reported pneumonia in approximately 5% of COPD patients using Relvar 92/22 over 16 months. The MHRA has issued Drug Safety Updates regarding this risk.

Be alert to worsening cough, increased or discoloured sputum, fever, and new-onset breathlessness. Seek medical attention promptly if pneumonia is suspected.

Systemic corticosteroid effects

With long-term use at higher doses, fluticasone furoate may cause systemic effects including adrenal suppression, reduced bone mineral density, growth retardation in children (Relvar is licensed from age 12), and rarely cataracts or glaucoma.

Your prescriber should aim to use the lowest effective dose to minimise these risks.

When to seek medical advice

Seek emergency medical attention (call 999) if you experience severe worsening of breathlessness, wheeze, or an asthma attack that does not respond to your reliever inhaler.

Contact your GP or call NHS 111 if you develop signs of oral thrush, persistent hoarseness, symptoms of pneumonia, or worsening symptoms.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Relvar is contraindicated in patients with hypersensitivity to fluticasone furoate, vilanterol, or any excipient (including lactose monohydrate). Patients with severe milk protein allergy should not use Relvar. It is not indicated for acute bronchospasm.

Monitoring and review

Your prescriber should review your asthma or COPD management at least annually, assessing symptom control, lung function, exacerbation frequency, inhaler technique, and adherence.

The aim is to step down to the lowest effective ICS dose once good control has been maintained for at least 3 months.

Do not step down without medical guidance.

Drug interactions

Beta-blockers (including ophthalmic preparations) may reduce the bronchodilator effect of vilanterol. Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, cobicistat) increase systemic exposure to both fluticasone furoate and vilanterol.

Avoid concomitant use unless the benefit outweighs the risk. Other sympathomimetic bronchodilators may increase the risk of cardiovascular side effects.

Lifestyle advice for asthma and COPD

Medication is one component of effective disease management. Smoking cessation is the single most important intervention for COPD and also benefits asthma control.

Annual influenza vaccination and pneumococcal vaccination are recommended for patients with asthma and COPD.

Regular physical activity, pulmonary rehabilitation (for COPD), maintaining a healthy weight, and avoiding known triggers all contribute to improved outcomes.

The NHS Smokefree service and the British Lung Foundation provide valuable support and information.

How to get Relvar Ellipta in the UK

Relvar Ellipta is available on NHS prescription from your GP, asthma nurse, respiratory specialist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Prepayment certificates are available for those who need multiple prescription items.

Sources

• Relvar Ellipta 92/22, Summary of Product Characteristics (EMC)
• Fluticasone furoate with vilanterol, British National Formulary (BNF)
• NICE NG80: Asthma, diagnosis, monitoring, and chronic asthma management
• NICE NG115: Chronic obstructive pulmonary disease in over 16s
• BTS/SIGN British Guideline on the Management of Asthma
• Asthma, NHS
• MHRA Yellow Card Scheme