TRELEGY ELLIPTA Powder For Inhalation (Fluticasone Furoate + Umeclidinium + Vilanterol) to Treat COPD & Asthma
Trelegy Ellipta is designed to manage and prevent symptoms associated with Chronic Obstructive Pulmonary Disease (COPD) and asthma in adults. It is a once-daily inhalation powder combining three active ingredients: Fluticasone Furoate (an inhaled corticosteroid), Umeclidinium (a long-acting muscarinic antagonist), and Vilanterol (a long-acting beta2-adrenergic agonist). By reducing inflammation and relaxing airway muscles, Trelegy Ellipta helps improve breathing and reduce the frequency of flare-ups.
Product Overview
Trelegy Ellipta is to simplify treatment regimens for adults with COPD and asthma, by reducing inflammation, relaxing airway muscles, and improving breathing for better long-term lung function control and replacing the need for multiple separate inhalers and improving daily lung function. This advanced formulation is a breakthrough "3-in-1" inhalation inhaler that combines Fluticasone Furoate, Umeclidinium, and Vilanterol therapy designed for the comprehensive, long-term maintenance of chronic respiratory conditions. It is the first once-daily single-inhaler triple therapy (SITT) that combines three powerful medicines to provide 24-hour symptom control.
Product Composition
Trelegy Ellipta utilizes a sophisticated triple-action formula containing three active pharmaceutical ingredients:
- Fluticasone Furoate: An inhaled corticosteroid (ICS) that targets and reduces airway inflammation.
- Umeclidinium: A long-acting muscarinic antagonist (LAMA) that blocks the tightening of muscles around the airways.
- Vilanterol: A long-acting beta2-adrenergic agonist (LABA) that helps the airways stay open for easier breathing.
Product Specification
| Feature | Details |
| Therapeutic Class | Triple Therapy Bronchodilator / Corticosteroid |
| Inhalation Device | Ellipta (Dry Powder Inhaler) |
| Primary Indications | Maintenance of COPD and Asthma in Adults |
| Dosage Frequency | Once Daily (One Actuation) |
| Active Strengths | 100/62.5/25 mcg |
Mechanism of Action
Trelegy Ellipta works through three distinct pathways to ensure clear and open airways throughout the day and night:
- Anti-Inflammatory Action: Fluticasone Furoate reduces the swelling and irritation in the small air passages of the lungs. By decreasing inflammation, it prevents the long-term damage and sensitivity that lead to flare-ups.
- Bronchial Relaxation: Vilanterol acts as a long-acting bronchodilator by stimulating beta2-receptors in the lungs. This causes the smooth muscles of the bronchial tubes to relax, significantly increasing airflow.
- Anticholinergic Blockade: Umeclidinium prevents the neurotransmitter acetylcholine from binding to receptors in the airway muscles. This action stops the muscles from contracting or "pinching" shut, providing a second layer of bronchodilation.
- 24-Hour Sustained Release: The formulation is designed for slow release, ensuring that all three components remain active in the lungs for a full 24 hours with a single dose.
Key Benefits
- Triple Therapy Convenience: Combines an ICS, LAMA, and LABA in one single device, eliminating the confusion and hassle of using multiple inhalers every day.
- Enhanced Lung Function: Clinical studies demonstrate significant improvements in FEV1 (forced expiratory volume) levels, helping patients breathe more deeply and easily.
- Exacerbation Reduction: Effectively lowers the frequency of "flare-ups" or exacerbations that can lead to hospitalizations for COPD and asthma patients.
- Consistent 24-Hour Relief: A single morning or evening dose provides round-the-clock protection, reducing nighttime symptoms and morning breathlessness.
- User-Friendly Design: The Ellipta inhaler features a simple "Slide, Inhale, Close" process with a large, easy-to-read dose counter to track remaining medication.
Precautions
Trelegy Ellipta Powder for Inhalation (Fluticasone Furoate + Umeclidinium + Vilanterol) should be used carefully to ensure safe and effective management of COPD or asthma.
Medical Conditions to Inform Your Doctor
| Medical Condition | Why It Matters |
|---|---|
| Heart disease (arrhythmia, hypertension) | Vilanterol may affect heart rate and rhythm |
| Glaucoma or increased eye pressure | Umeclidinium may worsen symptoms |
| Prostate enlargement or urinary retention | Anticholinergic effect may increase difficulty in urination |
| Liver disease | May affect drug metabolism |
| Thyroid disorders | Can increase sensitivity to bronchodilators |
| Seizure disorders | May increase risk of side effects |
| Lung infections (current or recent) | Steroid component may worsen infections |
Inhaler Use Precautions
- Use exactly once daily as prescribed
- Do not use for sudden breathing problems or asthma attacks
- Rinse mouth after use to reduce risk of oral thrush
- Do not swallow the powder capsule
Infection Risk
- Fluticasone may reduce immunity in lungs
- Watch for signs of infection such as fever, sore throat, or worsening cough
- Report persistent respiratory symptoms to a doctor
Eye and Urinary Effects
- May increase risk of blurred vision or eye pressure changes
- Can cause difficulty in urination in patients with prostate issues
Cardiovascular Precautions
- May increase heart rate or cause palpitations
- Use cautiously in patients with existing heart conditions
Pregnancy and Breastfeeding
- Use only if clearly prescribed by a doctor
- Limited safety data available, so medical supervision is essential
Important Advice
- Do not stop abruptly without medical advice
- Regular lung function monitoring is recommended
- Always carry a rescue inhaler for sudden symptoms
Usage
For maximum therapeutic benefit, Trelegy Ellipta must be used consistently every day. It is designed for maintenance and should not be used to treat a sudden attack of breathlessness or wheezing.
Dosage
The dose is standardized for 24-hour coverage. It is critical to follow the specific strength prescribed (either 100/62.5/25 mcg or 200/62.5/25 mcg) based on the severity of the respiratory condition.
| Aspect | Recommendation |
| Standard Frequency | One inhalation once daily |
| Consistent Timing | Use at the same time every day |
| Missed Dose | Take as soon as remembered, but do not take more than one dose per day |
| Device Life | Discard 6 weeks after opening the foil tray or when the counter reads "0" |
Administration
Inhalation Technique: Slide the cover down until you hear a "click." Breathe out fully away from the inhaler, place the mouthpiece between your lips, and take one long, steady, deep breath in.
Breath Holding: Hold your breath for about 3 to 4 seconds to allow the powder to settle deep into the lungs.
Post-Inhalation Care: Rinse your mouth with water and spit it out after every dose. This is a vital step to help prevent oral thrush (fungal infections) due to the corticosteroid component.
No Priming: The Ellipta device does not require shaking or priming before use; the dose is prepared automatically when the cover is opened.
Uses
Trelegy Ellipta is indicated for the long-term, once-daily maintenance treatment of airflow obstruction in adults. It addresses the underlying causes of chronic breathing difficulties through its triple-action formula.
Maintenance of COPD: It is used for the long-term treatment of Chronic Obstructive Pulmonary Disease, including chronic bronchitis and emphysema, to improve breathing and reduce the frequency of flare-ups.
Asthma Management: It is prescribed for adults with asthma who remain symptomatic despite using a combination of other inhaled controller medications.
Airway Obstruction Prevention: By providing continuous bronchodilation, it prevents the narrowing of the airways, making it easier for air to move in and out of the lungs throughout the day and night.
Reduction of Exacerbations: Regular use helps decrease the risk of sudden worsening of symptoms that might otherwise require emergency medical intervention or hospitalization.
Side Effects
Trelegy Ellipta Powder for Inhalation (Fluticasone Furoate + Umeclidinium + Vilanterol) may cause side effects, although not everyone experiences them. Most are mild, but some may require medical attention.
Common Side Effects
- Headache
- Sore throat
- Upper respiratory tract infections
- Cough
- Hoarseness or voice changes
- Dry mouth
- Nasal congestion
- Sinus infection
Less Common Side Effects
- Dizziness
- Tremors or shakiness
- Increased heart rate or palpitations
- Muscle cramps
- Blurred vision
- Difficulty urinating
Serious Side Effects
| Serious Condition | Symptoms |
|---|---|
| Severe allergic reaction | Swelling of face, lips, tongue, rash, breathing difficulty |
| Pneumonia | Fever, chills, increased cough, chest pain, difficulty breathing |
| Eye problems (glaucoma or increased eye pressure) | Eye pain, blurred vision, halos around lights |
| Adrenal suppression | Fatigue, weakness, low blood pressure, nausea |
| Paradoxical bronchospasm | Sudden worsening of breathing after inhalation |
| Severe infection | High fever, persistent sore throat, worsening respiratory symptoms |
Important Advice
- Rinse mouth after each use to reduce risk of oral thrush
- Use exactly as prescribed, once daily
- Report any persistent or worsening symptoms to a doctor immediately
Interactions
Trelegy Ellipta Powder for Inhalation (Fluticasone Furoate + Umeclidinium + Vilanterol) may interact with certain medicines and substances, which can increase side effects or reduce treatment effectiveness.
Respiratory and Bronchodilator Medicines
| Medicine Class | Interaction Effect |
|---|---|
| Other long acting beta agonists (LABA) | Increased risk of heart-related side effects such as palpitations and tachycardia |
| Other anticholinergics (e.g., ipratropium, tiotropium) | Increased anticholinergic effects like dry mouth, urinary retention |
| Systemic corticosteroids | Higher risk of steroid related side effects such as adrenal suppression |
Heart and Blood Pressure Medicines
- Beta blockers (e.g., propranolol) may reduce effectiveness of Vilanterol and worsen breathing symptoms
- Diuretics (water pills) increase the risk of low potassium levels and heart rhythm disturbances
- Antiarrhythmic drugs may increase the risk of abnormal heart rhythms
Antifungal and Antibiotic Medicines
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase Fluticasone levels and raise the risk of systemic steroid side effects
Other Medicines
- Monoamine oxidase inhibitors (MAOIs) may increase risk of cardiovascular side effects
- Tricyclic antidepressants may enhance heart-related effects of Vilanterol
- Other inhaled corticosteroids may increase risk of steroid overexposure
General Advice
- Inform your doctor about all prescription, OTC, and herbal medicines
- Avoid using similar inhalers unless specifically prescribed
- Regular monitoring of heart and respiratory function is recommended
| Manufacturer | : | Glaxo SmithKline Pharmaceuticals Ltd |
| Trade Name | : | Trelegy Ellipta |
| Generic Search | : | Fluticasone Furoate + Umeclidinium + Vilanterol |
| Strength | : | 100mcg-62.5mcg-25mcg |
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