Revinty Ellipta

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Revinty Ellipta

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Revinty Ellipta

Quick Facts

Property Description
Active ingredient Fluticasone Furoate / Vilanterol
Form Inhalation powder (Dry-powder inhaler)
Pharmacological class Inhaled Corticosteroid / Long-Acting Beta2-Agonist (ICS/LABA)
Common use Long-term maintenance treatment (not for acute relief)
Origin Synthetic chemical compounds

What Type of Combination Medicine is Revinty Ellipta?

Revinty Ellipta is a prescription-only fixed-dose combination product designed for the long-term, maintenance treatment of chronic respiratory conditions; it is explicitly not indicated for the immediate relief of acute bronchospasm. This medicine falls under the therapeutic classification of Adrenergics and other drugs for obstructive airway diseases, specifically an Inhaled Corticosteroid (ICS) combined with a Long-Acting Beta2-Agonist (LABA). This controller therapy is clinically recognized for its role in managing progressive airway conditions.

Composition and Pharmaceutical Form (Fluticasone Furoate/Vilanterol)

The medication contains two distinct synthetic active ingredients: Fluticasone Furoate and Vilanterol. Fluticasone Furoate provides the anti-inflammatory activity, while Vilanterol is the long-duration bronchodilator component. This formulation is also known internationally by the brand names Relvar Ellipta and Breo Ellipta. Revinty Ellipta is provided as a pre-dispensed inhalation powder, which is administered once daily via the specialized Ellipta dry-powder inhaler system, differentiating its administration frequency compared to several older ICS/LABA combinations.

What is the General Purpose of Revinty Ellipta?

The general purpose is to ensure continuous stability of respiratory function through a synergistic mechanism. By integrating the anti-inflammatory activity of the corticosteroid with the prolonged bronchodilator effect of the long-acting beta2-agonist, the medicine helps to reduce swelling while concurrently maintaining the opening of air passages. This integrated approach is crucial for achieving consistent, stable breathing control necessary for effective long-term management of chronic airway disease.

Regulatory References

  1. Revinty Ellipta EPAR

What side effects are possible with Revinty Ellipta?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and safety characteristics of Revinty Ellipta (Fluticasone Furoate/Vilanterol) as classified by governmental regulatory authorities.

Adverse effects are categorized by the body system affected and the observed frequency in clinical studies. Very Common reactions (affecting more than 1 in 10 people) include headache and nasopharyngitis. Common reactions (up to 1 in 10 people) are numerous and span several System-Organ Classes, involving infections like pneumonia (reported more frequently in COPD patients), bronchitis, and oral candidiasis; cardiac effects such as tachycardia and extrasystoles; and musculoskeletal events like back pain and fracture.

Frequency Classification Examples of Documented Reactions
Very Common Headache, Nasopharyngitis
Common Pneumonia (COPD), Oral Candidiasis, Tachycardia, Fracture, Depression
Uncommon Atrial fibrillation, Hypersensitivity Reactions, Blurred Vision

Serious adverse reactions highlighted in regulatory labeling include the risk of pneumonia, particularly for individuals with COPD, and the rare but clinically significant event of paradoxical bronchospasm, which is an immediate, unexpected worsening of breathing after inhalation. The potential for systemic corticosteroid effects (e.g., adrenal suppression, glaucoma) is also noted, particularly with prolonged use of the inhaled corticosteroid component.

Official safety notes define certain restrictions. The medicine is not indicated for the relief of sudden or acute breathing difficulties. Caution is advised for patients with pre-existing cardiovascular disorders or moderate to severe hepatic impairment, as these conditions may increase systemic exposure to the active ingredients. Furthermore, the product is formally contraindicated in individuals with a known severe allergy to milk proteins, an excipient in the formulation.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Fluticasone Furoate/Vilanterol (Revinty Ellipta) defines overdose based on the effects of its two active components, guiding the need for emergency response.

Overdose Domain Documented Manifestations
Acute Overstimulation Associated with the Vilanterol component, leading to clinical signs such as tachycardia, palpitations, tremor, nervousness, and chest discomfort. Physiological findings may include hypokalemia and hyperglycemia.
Chronic Overexposure Related to the Fluticasone Furoate component, potentially resulting in adrenal suppression (HPA axis suppression) and Hypercorticism following prolonged high-dose use.

Mandatory Emergency Actions and Monitoring

Immediate medical attention must be sought for any suspected overdose. Emergency services must be contacted immediately for life-threatening presentations such as seizures, collapse, or sudden severe breathing difficulty. The official management approach is symptomatic and supportive treatment, with consideration given to continuous ECG monitoring for cardiac status. No specific antidote is known for the combination product. Regulatory documentation notes that patients with moderate or severe hepatic impairment may require monitoring for systemic corticosteroid effects due to increased drug exposure.

Therapeutic Uses of Revinty Ellipta

Quick Facts

  • Condition Supported: Chronic Obstructive Pulmonary Disease (COPD) in adults.
  • Condition Supported: Regular treatment of asthma in adults and adolescents (12 years and older).
  • Therapeutic Action: Contributes to the long-term maintenance of airway patency.
  • Therapeutic Action: Used to address the risk of symptom flare-ups in COPD.

What Revinty Ellipta Treats: Main Uses and Benefits

Revinty Ellipta is authorized for the regular, long-term therapeutic management of two primary respiratory conditions. It is not indicated for the acute relief of sudden breathing difficulties.

Asthma Management

For adults and adolescents aged 12 years and older, this medication is a treatment option when a combination product is considered suitable. This includes individuals whose asthma symptoms are not sufficiently addressed by an inhaled corticosteroid and a short-acting beta2-agonist, or those who are already receiving satisfactory support from a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

Chronic Obstructive Pulmonary Disease (COPD)

In adult patients, Revinty Ellipta is indicated for the symptomatic treatment of COPD. Its use is focused on individuals with a history of disease exacerbations despite ongoing regular bronchodilator support. Use of the medicine may assist in addressing the frequency of these flare-ups and contribute to better air flow, which is a key measure of lung function.

This medication is a maintenance treatment designed for daily, routine administration to support long-term respiratory function.

Eligibility and Restrictions for Use

Revinty Ellipta (fluticasone furoate/vilanterol) is authorized for use in specific populations as defined by regulatory bodies.

Eligibility Scope

Population Status Condition Eligibility Status (Regulatory)
Approved Age Asthma Adults and Adolescents (12 years and older)
Approved Age COPD Adults (18 years and older)
Use Not Recommended Asthma Children under 12 years (Safety not established)
Use Not Recommended COPD Patients under 18 years (No relevant use)

Contraindications and Restrictions

Use is contraindicated in patients with a known hypersensitivity to the medicine's active ingredients or any excipients, including a severe milk-protein allergy. It must not be used for the relief of acute symptoms or an acute exacerbation of asthma or COPD, as it is a long-term maintenance medicine.

Condition-Specific Restrictions

Patients with moderate or severe hepatic impairment (liver disease) are subject to a dose limitation, generally restricted to the lowest available strength. Caution is advised for patients with certain cardiovascular disorders or co-existing conditions such as thyrotoxicosis or diabetes mellitus. For pregnant or breastfeeding women, use is generally considered only after assessing if the benefit to the mother outweighs the potential risk.

What should I know about interactions with other medicines?

The official interaction profile for Revinty Ellipta (Fluticasone Furoate/Vilanterol) is defined by pharmacokinetic and pharmacodynamic constraints documented by regulatory authorities.

Contraindicated and Restricted Combinations

The most significant restriction is the formal contraindication against co-administration with other medicines that contain a Long-Acting Beta2-Agonist (LABA). This prohibition is imposed due to the risk of an overdose and excessive systemic exposure to the LABA component, Vilanterol.

Pharmacokinetic Interaction Risk

Both active ingredients are cleared by the liver enzyme Cytochrome P450 3A4 (CYP3A4). Co-administration with strong CYP3A4 inhibitors (such as Ketoconazole, Ritonavir, or Cobicistat-containing products) may lead to increased systemic exposure to both Fluticasone Furoate and Vilanterol, which requires caution.

Pharmacodynamic Interactions

  • Beta-blockers: Use is advised against, as both selective and non-selective agents may block or antagonize the intended bronchodilatory effect of Vilanterol, potentially resulting in severe bronchospasm.
  • MAOIs and TCAs: These substances, including Monoamine Oxidase Inhibitors and Tricyclic Antidepressants, must be used with caution, as they can potentiate the effects of Vilanterol on the vascular system.
  • Diuretics: The co-administration of non–potassium-sparing diuretics carries a documented risk of increasing the potential for hypokalemia or specific electrocardiographic changes.

Population-Specific Notes

Patients with moderate or severe hepatic impairment are identified as having a greater risk of increased systemic exposure to the active ingredients, which is a key consideration when assessing interaction risk.

Mechanism of Action

Anti-Inflammatory Pathway Modulation (Fluticasone Furoate)

This domain involves receptor-mediated signaling within cells that drive cellular responses. The active component, fluticasone furoate, engages the glucocorticoid receptor to initiate or suppress specific genetic transcription sequences. This activity decreases the transcription and subsequent release of pro-inflammatory mediators from multiple immune cell types. This modifies the cellular signaling cascades responsible for inflammatory processes.

Bronchial Smooth Muscle Regulation (Vilanterol)

This mechanistic domain is centered on enzyme-mediated signaling that influences smooth muscle tension. The active component, vilanterol, is a selective agonist of the beta-2 adrenergic receptor located on the bronchial smooth muscle. Receptor binding stimulates the enzyme adenylyl cyclase, which increases the intracellular concentration of cyclic AMP (cAMP). This molecular cascade modulates a key pathway that ultimately leads to the relaxation and widening of the bronchial passages, resulting in bronchodilation.

Dual-Pathway Synergism

The two distinct mechanisms engage different cellular and molecular targets. The combined effect modifies both inflammatory signaling and bronchial smooth muscle tension over time, influencing two core physiological pathways simultaneously.

Dosage and Administration Information

How to Use Revinty Ellipta: Administration Guidelines

Revinty Ellipta (fluticasone furoate/vilanterol) is a prescription medicine intended for long-term maintenance treatment and is strictly administered by oral inhalation using the specialized Ellipta dry-powder inhaler. It must be used consistently and is not indicated for the relief of sudden breathing difficulties.

Standard Dosing and Frequency

Revinty Ellipta is taken as one single inhalation once daily, at the same time every day. The decision to use the dose in the morning or evening is determined by the prescriber. It is crucial not to use the medicine more than once every 24 hours.

Indication Standard Daily Dose (Delivered) Maximum Dose (Delivered)
COPD (Adults) 92 mcg/22 mcg 92 mcg/22 mcg (Higher strength is prohibited for COPD)
Asthma (Adults & Adolescents 12 yrs) 92 mcg/22 mcg (Starting/Lower) 184 mcg/22 mcg

Administration Requirements and Adjustments

Usage Steps: The device cover must be opened immediately before use to load the dose. Following inhalation, patients are instructed to rinse their mouth with water without swallowing to help reduce the risk of localized oral effects. If the inhaler cover is opened and closed without inhaling, the dose is lost.

Missed Dose: If a dose is missed, the patient should skip the missed dose and take the next scheduled dose at the usual time the following day; a double dose is prohibited.

Specific Populations: For patients with moderate to severe hepatic impairment, the maximum allowable dose is restricted to 92 mcg/22 mcg. The safety and efficacy of the medicine are not established for use in children under 12 years of age for asthma.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Revinty Ellipta


Evidence for Use in Chronic Obstructive Pulmonary Disease (COPD)

Research into Revinty Ellipta for the long-term management of COPD primarily involved Randomized Controlled Trials (RCTs) and large-scale, open-label, real-world effectiveness studies. These studies was studied for adults who already had established COPD, especially those with conditions involving periods of heightened symptoms that required prior care. The research applied in studies examining patient-reported experiences and focused on outcomes describing episodic or acute changes.

The research examined changes measured during the study period in objective lung function measures, such as the forced expiratory volume in 1 second ( FEV1), to observe patterns related to sustained air passage opening. Furthermore, studies monitored outcomes capturing phases of heightened symptom activity, which involved counting the frequency of moderate or severe COPD flare-ups (exacerbations).

The research so far indicates patterns observed in the studies, with data reporting how the combination was observed in studies with respect to the rate of exacerbations compared to the individual components alone. Research explored how the combination was observed in studies with respect to the measured rates of exacerbations compared to the individual components alone. However, the evidence also suggests that the higher dose of the combination was observed in studies where research described measurements similar to the lower dose ( 92/ 22 mu g). The results apply only to the populations studied, which were mainly adults with moderate to very severe COPD.


Evidence for Use in Regular Asthma Treatment

The evidence base for the regular treatment of asthma in adults and adolescents (age 12 and older) included rigorous Randomized Controlled Trials (RCTs) and comparative trials against other existing combination inhalers. Research examined conditions characterized by fluctuating or episodic manifestations where symptoms may vary in intensity. The studies monitored outcomes reflecting daily functioning or activity level to determine changes over defined time intervals.

Studies explored the impact on objective lung function parameters and tracked validated asthma control scores to assess how patient symptoms evolved in the observed populations. Research describes measurements of the frequency of episodes where symptoms become more noticeable (exacerbations) across the different treatment arms. Findings from comparative trials explored symptom patterns for this once-daily combination and studies monitored responses compared to certain twice-daily combination regimens.


Long-Term Studies and Durability of Follow-up

The main clinical trials conducted for both COPD and asthma typically involved follow-up durations that were limited to intermediate-term periods, often lasting between six months and one year. Research exploring short-term symptom changes over these defined time intervals provides insight into the initial response to treatment.

There is limited information for long-term outcomes beyond the one-year mark in the initial core studies. While some trials may be ongoing to evaluate survival outcomes or effects over multiple years in specific COPD populations, the long-term effects are not fully established for all aspects of the medicine's use.


Evidence in Specific Patient Groups (Special Populations)

The research was evaluated in a wide range of adults with both conditions and studies monitored adolescents (age 12 and older) with asthma. For these groups, studies help show what has been observed so far in terms of physiological and subjective changes.

However, the data for certain groups remain insufficient. For instance, the research was not observed in or has not established the safety profile for children under 12 years old for the asthma indication.


Key Research Gaps and Uncertainties

The evidence highlights what is known and what is still uncertain about this combination therapy. One gap noted in the research is that studies exploring the measured outcomes of the higher FF/VI dose ( 184/ 22 mu g) for the COPD indication described measurements similar to the lower dose, meaning that research findings apply predominantly to the lower dose.

Furthermore, data are still emerging regarding the very long-term effects, as long-term outcomes are not fully established beyond the one-year follow-up of the initial trials. The comparative evidence is lacking for many new therapies, and the study results reflect the specific conditions under which they were conducted, meaning research does not determine whether an individual will respond similarly. Findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Revinty Ellipta (FAQ)


Q: Why might Revinty Ellipta cause an infection in the mouth or throat, like oral thrush?

Regulatory documents indicate that oral candidiasis (a fungal infection, commonly known as thrush) is a known potential side effect of the inhaled corticosteroid component. Official documentation describes rinsing the mouth with water without swallowing after inhalation as a method to help reduce this risk.


Q: Are there specific symptoms that indicate a serious allergic reaction to the medicine?

Official product information notes that serious allergic reactions may occur with this medicine. Symptoms of these reactions, such as anaphylaxis or angioedema, can include rash, hives, or swelling of the face, mouth, and tongue, or trouble breathing. Regulatory documents emphasize that if these signs appear, immediate medical attention is a necessary action.


Q: What is adrenal suppression, and is it a potential risk of using Revinty Ellipta?

Adrenal suppression (or adrenal insufficiency) is a condition where the adrenal glands produce insufficient steroid hormones. Because Revinty Ellipta contains a corticosteroid, this condition is noted as a potential risk associated with inhaled steroids. This effect is noted particularly with high dosages or in certain susceptible individuals.


Q: Does grapefruit juice interact with Revinty Ellipta?

Regulatory documents describe a risk of interaction with certain compounds, such as strong CYP3A4 inhibitors, which are substances that can increase the amount of drug absorbed into the body. Because grapefruit juice can act as one of these inhibitors, caution is generally advised, as these products may increase systemic exposure to the medicine.


Q: What is the general timeline for patients to notice an improvement in breathing after starting Revinty Ellipta?

Studies and official information indicate that most patients experience an initial improvement in lung function, such as airway opening, relatively quickly, usually within 15 to 17 minutes of the first dose. However, the maximum benefit of the medicine for overall, consistent breathing control may take up to two weeks or longer to be fully achieved.


Q: What should be done if asthma symptoms worsen after starting Revinty Ellipta?

According to the official product information, this medicine is intended for long-term maintenance and is not to be used for acute symptoms. If symptoms arise between doses, a short-acting beta2-agonist (SABA) is described as the appropriate medicine for immediate relief. If asthma or COPD symptoms are rapidly or significantly worsening, regulatory documents indicate that the therapeutic regimen requires immediate re-evaluation by a healthcare professional.


Q: Is it normal not to taste or feel the powder when inhaling Revinty Ellipta?

Revinty Ellipta is a dry-powder inhaler designed to deliver the dose rapidly and effectively. Instructions focus on confirming the dose by hearing the click when the cover is opened and breathing in steadily. Official information does not specify a taste or physical sensation; therefore, successfully inhaling the medicine is not dependent on feeling or tasting the powder.


Q: How do I know if I have inhaled the medicine correctly?

Regulatory-linked patient instructions focus on the administration technique: the dose is loaded by opening the cover until a click is heard, and the user must then breathe in steadily and deeply through the mouthpiece. Official guidance describes that, after removing the device from the mouth, successful inhalation involves holding the breath for a defined period.


Q: How long does the Ellipta inhaler last before needing a replacement?

The Ellipta inhaler is a disposable device containing a fixed number of doses (e.g., 30 doses per standard pack). Regulatory documentation specifies two limits: the inhaler must be discarded six weeks after the foil tray is first opened, even if medicine remains, and also once the dose counter reaches zero.


Q: Have there been studies on the potential effects of Revinty Ellipta on children's growth?

Inhaled corticosteroids, as a class, are generally studied for potential effects on growth rate in children. Official studies, including those reviewed by the EMA, have specifically evaluated the effects of the fluticasone furoate component on growth over time. These studies help inform the product's use restriction in children under 12 years of age.


Q: Are there any specific foods or drinks that should be avoided when using Revinty Ellipta?

Official regulatory information focuses primarily on interactions with other medicines, particularly those that inhibit the CYP3A4 enzyme (like grapefruit juice). No other specific general food or drink restrictions are stated in the main sections of the regulatory labeling for this medicine.


Q: Can antibiotics interfere with the way Revinty Ellipta works?

Interference is noted only for certain medicines that are strong inhibitors of the CYP3A4 enzyme. The class is broad; only specific medications known as strong CYP3A4 inhibitors are described in the regulatory context as agents that may increase the systemic exposure of the Revinty Ellipta components. Official information advises caution when co-administering any potent CYP3A4 inhibitor.


Q: Is it important to tell my healthcare provider about all vitamins and herbal supplements before using Revinty Ellipta?

Regulatory patient counseling information generally advises users to disclose all medications, including nonprescription medicines, vitamins, and herbal supplements, to their healthcare provider. This is because some supplements, such as St. John's Wort, can affect the metabolism of the active ingredients in Revinty Ellipta.


Q: Can Revinty Ellipta be used by people who have a history of tuberculosis or other chronic infections?

Official product information advises that the medicine should be used with caution in patients with certain pre-existing conditions. These include infections such as existing or quiescent tuberculosis, as well as other fungal, bacterial, viral, or parasitic infections.


Q: How is Revinty Ellipta different from the triple therapy inhaler Trelegy Ellipta?

Revinty Ellipta is officially classified as a fixed-dose combination of two medicines (an inhaled corticosteroid and a long-acting beta2-agonist). In contrast, Trelegy Ellipta is a fixed-dose combination of three medicines (adding a long-acting muscarinic antagonist). Both are designed for maintenance treatment using the same Ellipta device platform.


Q: Can this medicine affect the results of other general medical tests?

Regulatory information notes that the medicine can lead to changes in certain laboratory blood values. Specifically, the drug has been documented to potentially cause high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), which may influence the results of relevant blood tests.


How should Revinty Ellipta be stored and disposed of?

Storage and Handling

Revinty Ellipta must be stored at room temperature, specifically between 20°C and 25°C (68°F and 77°F); exposure to temperatures between 15°C and 30°C is permitted for brief periods. The medicine must not be frozen or refrigerated.

To protect the sensitive inhalation powder from moisture, the inhaler must remain in its original, unopened foil tray until the day treatment begins. It must also be protected from direct heat and sunlight. The medicine must always be kept out of the sight and reach of children.

Stability and Disposal

The inhaler must be discarded six weeks after the foil tray is first opened, even if it contains residual medicine. This discard date must be recorded upon opening the tray.

Disposal of unused medicine and the inhaler device must follow local regulatory requirements and not be thrown away in household trash or via wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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