Arnuity Ellipta

Medically reviewed

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 Arnuity Ellipta

Quick Facts

Property	Description
Active ingredient	Fluticasone Furoate
Form	Dry Powder Inhalation (DPI)
Pharmacological class	Inhaled Corticosteroid (ICS)
Common use	Long-term control/maintenance therapy
Origin	Synthetic Corticosteroid

What is Arnuity Ellipta and How is it Classified?

Arnuity Ellipta is a synthetic prescription medicine defined by its single active ingredient, Fluticasone Furoate. This compound is classified as a corticosteroid and belongs specifically to the functional pharmacological class of Inhaled Corticosteroids (ICS). Inhaled corticosteroid agents are recognized as the foundational approach for managing persistent inflammatory airway conditions, a status reflected across medical guidelines. This medication is solely a maintenance controller intended for daily, long-term prophylactic therapy, a function that separates it from rescue inhalers used for treating immediate, acute breathing difficulties.

Composition, Drug Form, and Delivery System

The medicine is formulated as a Dry Powder Inhalation (DPI), intended for oral administration directly to the lungs via the specialized Ellipta inhaler device. The DPI formulation contains the active drug, Fluticasone Furoate, combined with Lactose Monohydrate, which serves as the carrier powder essential for dose delivery. The device is breath-actuated, meaning the patient's inspiratory effort is required to ensure the correct amount of powder is delivered deep into the airways.

What is the General Purpose of This Controller Medicine?

The general purpose of this controller medicine is to achieve sustained anti-inflammatory action and long-term stability within the airways. By delivering the corticosteroid locally, the medicine works consistently to reduce the underlying swelling and irritation in the bronchial tissues. This persistent anti-inflammatory effect is designed to reduce the hyper-responsiveness of the airways over time. The ultimate benefit is preventative: stabilizing breathing function and consistently managing chronic airway inflammation, rather than providing temporary symptomatic relief.

Regulatory References

Relvar Ellipta EPAR Summary

What side effects are possible with Arnuity Ellipta?

Possible side effects and safety information

The safety profile for Arnuity Ellipta (Fluticasone Furoate) is defined by classifications and constraints established in official regulatory documents. The most frequently documented adverse reactions, classified as Common or Very Common in clinical data, include upper respiratory tract infection, headache, nasopharyngitis, and bronchitis.

Adverse Reactions by System-Organ Class

Adverse reactions are grouped by the affected physiological system in official labeling. Effects are documented in the Infections and Infestations class, covering common occurrences like pharyngitis and local infections such as oral candidiasis (thrush) of the mouth and throat. Reactions are also noted in the Nervous System Disorders (headache) and the Musculoskeletal and Connective Tissue Disorders categories.

Serious Safety Considerations

The regulatory profile identifies the potential for rare but serious adverse reactions. These include paradoxical bronchospasm, an acute narrowing of the airways that can occur immediately after inhalation. The potential for severe hypersensitivity reactions, such as anaphylaxis and angioedema (swelling of the face, tongue, and throat), is also formally recognized in official labeling. Furthermore, the risk of systemic corticosteroid effects, including adrenal suppression and hypercorticism, is documented.

Safety Constraints and Special Populations

Official labels note high-level safety restrictions. The medicine is contraindicated in individuals with severe hypersensitivity to milk proteins or the active ingredient. For specific populations, official documents note that long-term use in children and adolescents may carry a potential risk for growth reduction. Additionally, the risk of decreased bone mineral density, cataracts, and glaucoma is associated with long-term exposure to inhaled corticosteroids.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Arnuity Ellipta (fluticasone furoate) primarily defines overdose not as acute poisoning, but as the potential for systemic corticosteroid effects following chronic overdosage or prolonged high-dose exposure.

Overdose manifestations relate to the drug's class effects and may include signs of hypercorticism (excessive systemic corticosteroid activity) or adrenal suppression (impaired HPA axis function). A potentially life-threatening acute adrenal crisis may occur in patients with HPA axis suppression, particularly during stress.

When to Seek Immediate Medical Attention

Immediate medical help must be sought for a confirmed or suspected overdose. Additionally, emergency attention is required for the following serious events:

Paradoxical Bronchospasm: Immediate, life-threatening worsening of wheezing or breathing difficulties after a dose.
Severe Allergic Reaction/Anaphylaxis: Symptoms such as swelling of the face, mouth, or tongue, difficulty breathing, or rash.

Management and Monitoring

Treatment for overdose is symptomatic and supportive, and no specific antidote is listed in government labeling. Management involves careful clinical observation and potential monitoring of HPA axis function. If signs of hypercorticism or adrenal suppression are noted, a gradual reduction or discontinuation of the drug, with consideration for alternative therapy, is required.

Patients with moderate or severe liver impairment may have increased drug exposure and require monitoring for systemic corticosteroid effects.

Therapeutic Uses of Arnuity Ellipta

What Arnuity Ellipta Treats: Main Uses and Benefits

This medication is commonly used for the maintenance treatment of asthma in relevant patient populations, including adolescents and adults. As a controller medicine, it is applied in contexts involving conditions characterized by periods of heightened symptoms that require foundational, continuous management. This approach is a recognized standard for the therapeutic management of asthma.

The medication is applied in situations involving recurrent or episodic manifestations, and is commonly used to help prevent the future occurrence of symptoms. It is relevant for easing symptom clusters that may become intense or disruptive, such as frequent wheezing, breathlessness, and persistent chest tightness associated with chronic airway disease. The medication may assist with managing symptoms that interfere with daily comfort.

“It is a foundational treatment applied to assist with maintaining functional stability over the long term.”

This sustained control contributes to easing the overall symptom load and may be part of symptomatic management that helps ease the overall symptom load during more noticeable episodes. It supports the patient during difficult phases and assists with maintaining functional stability.

Quick Fact: Management of Persistent Symptoms This controller medication is commonly used to help with groups of symptoms that may become intense or disruptive, such as chronic cough, wheezing, and chest tightness.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Arnuity Ellipta — Official Regulatory Information

The following rules define the approved patient population and exclusions for Arnuity Ellipta, based strictly on government regulatory documents.

Category	Eligibility Rule
Approved Age	Indicated for adults and pediatric patients mathbf5 years and older.
Use Not Established	Safety and effectiveness are not established in children under 5 years of age.
Acute Conditions	Contraindicated for the primary treatment of mathbfstatus asthmaticus or other acute asthma episodes (it is not a rescue medicine).
Hypersensitivity	Contraindicated in patients with known severe hypersensitivity to milk proteins (a component of the inhaler powder) or to fluticasone furoate.
Organ Impairment	Caution is required for use in patients with moderate or severe hepatic impairment due to the potential for increased systemic exposure. No dose adjustment is required for renal impairment or mild hepatic impairment.
Pregnancy/Lactation	Use is subject to a mathbfbenefit-risk assessment by a healthcare provider; it is not known if the medicine may harm an unborn baby or if it passes into breast milk.

What should I know about interactions with other medicines?

The interaction profile for Arnuity Ellipta (Fluticasone Furoate) is defined primarily by its clearance pathway and specific regulatory constraints. The drug's systemic clearance relies heavily on hepatic metabolism mediated by the Cytochrome P450 3A4 (CYP3A4) enzyme.

Documented Pharmacokinetic Interactions

Interacting Substance Class	Example Medicine	Officially Documented Effect
Potent CYP3A4 Inhibitors	Ketoconazole	Substantially increases systemic plasma exposure (AUC) of Fluticasone Furoate.

Co-administration of potent CYP3A4 inhibitors increases the amount of Fluticasone Furoate circulating in the body. This is a pharmacokinetic interaction that may lead to an increase in systemic corticosteroid activity.

Specific Regulatory Restrictions and Cautions

Restriction Type	Interacting Agent	Regulatory Mandate
Non-Recommended Combination	Ritonavir	Co-administration is not recommended due to the high risk of increased systemic exposure.
Caution	Other Corticosteroids	Concomitant use may increase the overall risk of developing systemic corticosteroid effects.

Population-Specific Interaction Notes

The risk of altered exposure is also documented for certain patient populations. Patients with moderate or severe hepatic impairment may experience increased systemic exposure to Fluticasone Furoate compared to those with healthy liver function. No mandatory timing or separation rules for administration are documented in the regulatory labeling.

Mechanism of Action

Glucocorticoid Receptor Activation

This domain acts within domains involving receptor-mediated signaling by binding to the intracellular glucocorticoid receptor (GR). This initiates a signaling sequence that alters gene transcription, a mechanistic cascade which modifies the synthesis of proteins involved in inflammatory signaling.

Modulation of Inflammatory Gene Expression

The activated receptor complex translocates to the cell nucleus where it modifies early molecular steps by interacting with DNA and transcription factors like NF- kappa B and AP-1. This action engages mechanisms that influence transcriptional factors within pathways by both decreasing pro-inflammatory gene transcription and enhancing anti-inflammatory gene expression.

Influencing Physiological Responses

The resulting effects on gene expression lead to the reduction of key inflammatory mediators, such as cytokines, chemokines, and leukotrienes. This decreases the impact of mediator activity within the bronchial system, influencing the state of localized physiological responses within airway tissues.

Dosage and Administration Information

The usage of Arnuity Ellipta is a once-daily, orally inhaled therapy for long-term control. The medicine is administered through the specialized Dry Powder Inhalation (DPI) device, with its use limited to one actuation every 24 hours.

Administration Scope

Category	Established Instructions
Route of administration	Oral inhalation only.
Dosing schedule	Adults/Adolescents (aged 12 years and older): Start at 100 mcg once daily; maximum is 200 mcg once daily. Children (5 to 11 years): 50 mcg once daily.
Frequency and Timing	One inhalation once daily (qDay), intended to be used at the same time every day.
Age-group rules	Approved for patients aged 5 years and older. The maximum daily dose for those aged 12 years and older with moderate or severe hepatic impairment is restricted to 100 mcg.
Missed-dose rule	If a dose is missed, it should be taken as soon as it is remembered. Do not take more than one inhalation per day or take two doses at one time.
Special procedural conditions	The medicine is not indicated for the relief of acute symptoms. The procedural use includes the mandatory step to rinse the mouth with water without swallowing after each administration.

Connection to the Use Protocol

The instructions define the use as a continuous, predictable, long-term protocol. The administration requires the exact oral inhalation route to ensure delivery to the airways. The constraint of only one inhalation per day at a consistent time establishes the maximum dosing frequency for continuous maintenance therapy.

Recent Clinical Evidence

Arnuity Ellipta: Recent Clinical Evidence

Arnuity Ellipta is a maintenance treatment for asthma in patients aged 5 years and older, containing the inhaled corticosteroid fluticasone furoate. Clinical trials have focused on evaluating its effectiveness and safety profile when administered once daily.

Efficacy and Lung Function

Studies in adults and adolescents (aged 12 and older) with persistent asthma showed that once-daily fluticasone furoate was associated with measurable improvements in lung function, particularly trough Forced Expiratory Volume in One Second ( FEV1), compared to placebo. A key goal of the research was to confirm efficacy over a 24-hour period, supporting the once-daily dosing regimen.

Dose Comparison: In trials comparing the 100 mcg and 200 mcg doses, both were associated with improved lung function and asthma control. For patients whose asthma was not adequately controlled on the 100 mcg dose after two weeks, an increase to the 200 mcg dose was studied and may provide further control.
Pediatric Studies: Evidence supports the use of a 50 mcg dose for children aged 5 to 11 years, with studies observing favorable changes in lung function measures like morning Peak Expiratory Flow (PEF) compared to placebo.

Safety Profile and Adverse Events

Safety data from trials involving over 3,600 patients showed that fluticasone furoate 100 mcg and 200 mcg had safety profiles consistent with other inhaled corticosteroids. The most commonly reported adverse events (occurring in 5% or more of adult and adolescent subjects) were:

Adverse Event Category	Incidence (Adults/Adolescents)
Infections and Infestations	Nasopharyngitis (Nose/Throat Infection)
Nervous System Disorders	Headache
Respiratory Disorders	Bronchitis

The risk of localized fungal infection (oral candidiasis) in the mouth or throat is associated with inhaled corticosteroid use, but this risk may be managed by rinsing the mouth with water without swallowing after use. Studies have also monitored potential systemic effects, such as reduced growth velocity in children, which is a known consideration for inhaled corticosteroid therapy.

Frequently Asked Questions (FAQ)

Common questions about Arnuity Ellipta (FAQ)

Q: What is the typical time frame to notice an improvement in breathing after starting Arnuity Ellipta?

Regulatory information indicates the medicine is designed for long-term maintenance. While effects on lung function have been observed in clinical studies over time, the full benefit usually requires consistent daily use for 1 to 2 weeks or longer.

Q: Does Arnuity Ellipta commonly cause headaches or a sore throat?

According to regulatory safety data, headache is listed as one of the most commonly reported adverse events. Other effects that have been reported include throat irritation, sore throat (pharyngitis), and hoarseness (a change in voice).

Q: Is it true that Arnuity Ellipta contains a milk protein allergen (lactose)?

Yes, Arnuity Ellipta is a dry powder inhaler that contains lactose monohydrate as a carrier. This carrier contains milk proteins. Official regulatory documents state the medicine is contraindicated (not to be used) in patients with known severe hypersensitivity to milk proteins.

Q: How long is Arnuity Ellipta typically prescribed for—is it a long-term treatment?

Official product information indicates that this medicine is intended for the long-term, once-daily maintenance treatment of asthma. It is not designed to be a temporary solution or a rescue treatment for sudden breathing problems.

Q: Can Arnuity Ellipta be used for conditions other than asthma, such as COPD?

Arnuity Ellipta is only approved by the FDA and other regulators as a maintenance treatment for asthma in patients aged 5 years and older. Its use for the treatment of Chronic Obstructive Pulmonary Disease (COPD) is not an approved indication.

Q: Is Arnuity Ellipta safe to use during pregnancy or while breastfeeding?

Data on the use of fluticasone furoate in pregnant women is limited, and it is not known if the medicine passes into breast milk or can harm a nursing baby. Regulatory information states that use during pregnancy or lactation is subject to a healthcare provider's benefit-risk assessment.

Q: What happens if I stop using Arnuity Ellipta suddenly, without talking to a healthcare provider?

Regulatory warnings state that therapy must not be stopped without a healthcare provider's guidance, as discontinuing the medicine may lead to a return or worsening of asthma symptoms. Stopping abruptly may also carry a risk of adrenal insufficiency for patients previously on systemic corticosteroids.

Q: What happens if I forget to rinse my mouth after taking a dose of Arnuity Ellipta?

The official instruction to rinse the mouth with water (without swallowing) after each dose is intended to help manage the risk of developing oral candidiasis (thrush), which is a local fungal infection. This step is a key preventative measure described in the official instructions.

Q: Can I use Arnuity Ellipta if I am taking medicines for HIV or a fungal infection?

Arnuity Ellipta interacts with powerful medicines known as potent CYP3A4 inhibitors, which are found in certain anti-HIV (e.g., ritonavir) and antifungal (e.g., ketoconazole) drugs. Co-administration of these types of medicines may increase the amount of fluticasone furoate in the body, which may increase the risk of systemic corticosteroid side effects.

Q: Is Arnuity Ellipta the same medication as Breo Ellipta?

No, Arnuity Ellipta and Breo Ellipta are different medicines. Arnuity Ellipta contains only one active ingredient, the corticosteroid fluticasone furoate. Breo Ellipta is a combination product that contains fluticasone furoate along with a second ingredient, vilanterol (a long-acting bronchodilator).

Q: Are there any foods or drinks, such as grapefruit juice, that can interact with Arnuity Ellipta?

Arnuity Ellipta is metabolized (processed) in the liver by an enzyme called CYP3A4. Substances like grapefruit juice may affect this enzyme pathway, which can potentially alter the systemic exposure of the drug in the body. This is a common caution associated with medicines metabolized by CYP3A4.

Q: Is there a generic version of Arnuity Ellipta available, or is it only available as a brand name?

According to official regulatory records, Arnuity Ellipta is available both as the brand-name product and as an authorized generic version. An authorized generic contains the exact same active ingredient, fluticasone furoate.

Q: Why does the Ellipta device make a clicking sound when it's opened?

The clicking sound is part of the inhaler's design and serves as an important operational signal. The click indicates that the device has been correctly opened, and the dose counter has moved to confirm the dose is now prepared and ready for inhalation.

Q: Can Arnuity Ellipta cause a change in sense of taste or smell?

Official adverse event information notes that a change in taste is a reaction that has been reported. Changes in the sense of smell are generally not listed as a commonly reported adverse event.

Q: What does it mean if my need for my quick-acting inhaler (rescue inhaler) increases while on Arnuity Ellipta?

An increased need for a quick-acting rescue inhaler is a sign of worsening asthma and suggests that the condition is no longer adequately controlled by the daily maintenance medicine. Regulatory warnings state that this sign of worsening asthma requires immediate contact with a healthcare provider.

Q: Does Arnuity Ellipta cause weight gain or affect appetite?

Weight gain is not specifically listed among the most commonly reported or serious adverse events in the regulatory documents. However, loss of appetite has been reported as a symptom related to potential systemic effects, such as low adrenal gland function.

Q: Is there a concern about using Arnuity Ellipta if I have a history of tuberculosis?

Regulatory documents state that due to potential effects on the body’s ability to resist infections, the use of this medicine requires caution in patients with active or quiescent tuberculosis or certain other infections.

How should Arnuity Ellipta be stored and disposed of?

Arnuity Ellipta: Storage and Disposal Requirements

Storage Conditions and Stability

Arnuity Ellipta (fluticasone furoate) must be stored at controlled room temperature, between 20^\circC and 25^\circC (68^\circF and 77^\circF). The product must be protected from moisture and direct heat or sunlight; it must not be refrigerated or frozen.

To preserve the dry powder formulation, the inhaler must remain in its original moisture-protective foil tray until its first use. The inhaler must be discarded 6 weeks after removal from the foil tray or when the dose counter reads "0," whichever comes first.