Trelegy Ellipta Powder for inhalation (Fluticasone Furoate (100mcg), Umeclidinium (62.5mcg) and Vilanterol (25mcg))

Drug Description for Trelegy Ellipta

Product Name:

Trelegy Ellipta

Drug Class and Categories:

• Drug Class: Respiratory Agents, Combination

• Categories: Long-Acting Beta2-Agonists (LABA), Inhaled Corticosteroids (ICS), Long-Acting Muscarinic Antagonists (LAMA)

Active Ingredient:

• Fluticasone Furoate (Inhaled Corticosteroid)

• Umeclidinium (Long-Acting Muscarinic Antagonist)

• Vilanterol (Long-Acting Beta2-Agonist)

Other Names:

• Trelegy

Mode of Action:

Trelegy Ellipta combines three medications in one inhaler to provide comprehensive management of chronic obstructive pulmonary disease (COPD) and asthma. Fluticasone furoate reduces inflammation in the lungs, umeclidinium relaxes airway muscles to open airways, and vilanterol relaxes bronchial muscles to ease breathing. Together, they improve lung function and reduce COPD exacerbations.

How to Use:

• Use Trelegy Ellipta exactly as prescribed by your healthcare provider.

• Inhale once daily at the same time each day.

• Follow the instructions for using the Ellipta inhaler properly to ensure you receive the correct dose.

Recommended Dosage:

• Adults with COPD or Asthma: One inhalation once daily, preferably at the same time each day.

Directions:

• Open the cover of the inhaler and slide down the mouthpiece cover until you hear a click.

• Exhale fully before placing the mouthpiece in your mouth.

• Inhale the medication deeply and hold your breath for about 10 seconds.

• Exhale slowly and close the mouthpiece cover until it clicks into place.

Cautions:

• Do not use Trelegy Ellipta to treat acute bronchospasm or asthma attacks.

• Inform your healthcare provider of any allergies, especially to fluticasone, umeclidinium, or vilanterol.

• Long-term use may increase the risk of pneumonia in patients with COPD.

• Regular monitoring of lung function is recommended.

Guidelines:

• Rinse your mouth with water without swallowing after using the inhaler to reduce the risk of oral thrush.

• Store Trelegy Ellipta at room temperature, away from moisture and heat.

• Keep the inhaler out of reach of children.

• Discard the inhaler 6 weeks after opening or when the dose counter reads "0," whichever comes first.

Frequently Asked Questions (FAQs):

Q: What should I do if I miss a dose of Trelegy Ellipta?

A: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at once to make up for a missed dose.

Q: Can Trelegy Ellipta be used to treat asthma?

A: Yes, Trelegy Ellipta is approved for the treatment of asthma in adults who require a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta2-agonist.

Q: What are the common side effects of Trelegy Ellipta?

A: Common side effects include upper respiratory tract infections, headache, back pain, and oral thrush. Contact your healthcare provider if these effects persist or worsen.

Q: Can I use Trelegy Ellipta with other medications?

A: Some medications can interact with Trelegy Ellipta. Inform your healthcare provider about all the medications and supplements you are taking.

Q: Is Trelegy Ellipta safe during pregnancy?

A: The safety of Trelegy Ellipta during pregnancy is not well established. If you are pregnant or planning to become pregnant, consult your healthcare provider to weigh the potential benefits and risks.

Q: How should I store Trelegy Ellipta?

A: Store at room temperature, away from moisture and heat. Keep the inhaler in its sealed tray until ready for use.

Q: How long does it take for Trelegy Ellipta to start working?

A: Some patients may experience an improvement in breathing within 24 hours, but it may take several days to experience the full benefits of the medication.

Q: Can I use Trelegy Ellipta for an asthma attack?

A: No, Trelegy Ellipta is not intended for the relief of acute bronchospasm or asthma attacks. Use a rescue inhaler for sudden breathing problems.

Q: How often should I use Trelegy Ellipta?

A: Use Trelegy Ellipta once daily, at the same time each day. Do not use it more than once every 24 hours.

Q: What if I experience severe side effects while using Trelegy Ellipta?

A: Seek immediate medical attention if you experience symptoms such as severe allergic reactions, difficulty breathing, or severe chest pain.

By following these guidelines and using Trelegy Ellipta as prescribed, you can effectively manage COPD or asthma and maintain your respiratory health. Always consult your healthcare provider for personalized advice and information.

What is Trelegy Ellipta?

Trelegy Ellipta is a once‑daily, triple‑therapy inhaler approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) and, in some regions, for asthma. It combines three active ingredients:

• Fluticasone Furoate: An inhaled corticosteroid (ICS) that reduces airway inflammation.
• Umeclidinium: A long‑acting muscarinic antagonist (LAMA) that relaxes airway smooth muscle by blocking muscarinic receptors.
• Vilanterol: A long‑acting beta‑agonist (LABA) that induces bronchodilation to improve airflow.

Reference: U.S. Food and Drug Administration (FDA) prescribing information; ClinicalTrials.gov (e.g., NCT02222720)

What are the other popular names for Trelegy Ellipta?

Trelegy Ellipta is primarily known by its brand name Trelegy Ellipta. It is sometimes referred to simply as Trelegy in clinical and patient communications. Its individual components are widely recognized under their generic names.

Reference: U.S. FDA; National Institutes of Health (NIH) clinical resources

What is the drug classification of Trelegy Ellipta?

Trelegy Ellipta is classified as a combination inhaled medication for respiratory diseases. It falls under the therapeutic category of triple therapy for COPD, combining an inhaled corticosteroid, a long‑acting muscarinic antagonist, and a long‑acting beta‑agonist.

Reference: American Thoracic Society (ATS) guidelines; FDA

What is the mode of action of Trelegy Ellipta?

Trelegy Ellipta works via a synergistic mechanism involving its three components:

• Fluticasone Furoate (ICS): Reduces airway inflammation and helps prevent exacerbations.
• Umeclidinium (LAMA): Blocks muscarinic receptors, leading to relaxation of airway smooth muscles and decreased bronchoconstriction.
• Vilanterol (LABA): Stimulates beta2‑adrenergic receptors, promoting bronchodilation and improved airflow.
  Together, these actions enhance lung function, reduce symptoms, and lower the frequency of exacerbations in patients with COPD.

Reference: New England Journal of Medicine (NEJM); U.S. FDA; ClinicalTrials.gov

How is Trelegy Ellipta used?

Trelegy Ellipta is indicated for the long‑term maintenance treatment of patients with COPD to reduce the risk of moderate to severe exacerbations and improve lung function. In some regions, it is also approved for asthma maintenance in patients who require both an ICS and long‑acting bronchodilator therapy. It is not intended for the relief of acute bronchospasm.

Reference: U.S. FDA; American Thoracic Society (ATS) guidelines

What is the recommended dosage and administration for Trelegy Ellipta?

• Dosage: The standard regimen is one inhalation once daily. The inhaler delivers a fixed dose of the three active ingredients (approximately 100 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol), although exact dosing may vary by regional approvals.
• Administration:
  • Use the Ellipta inhaler once daily at the same time each day.
  • Rinse your mouth after inhalation to reduce the risk of oral candidiasis.

Reference: U.S. FDA; ClinicalTrials.gov (e.g., NCT02222720)

What prescribing information is important for Trelegy Ellipta?

• Indications: Approved for maintenance treatment in patients with COPD (and in some regions, for asthma).
• Contraindications:
  • Not for use in patients with acute episodes of bronchospasm or as rescue therapy.
  • Contraindicated in patients with a known hypersensitivity to any component of the formulation.
• Monitoring:
  • Regular assessment of lung function and symptom control is recommended.
  • Periodic monitoring for potential side effects such as pneumonia or adrenal suppression is advised, especially in patients with a history of recurrent infections.
• Special Considerations:
  • Patients should be educated on proper inhaler technique.
  • It is not for immediate relief of acute symptoms.

Reference: U.S. FDA prescribing information; National Institutes of Health (NIH) clinical resources

What safety information, warnings, and cautions are associated with Trelegy Ellipta?

• Common Side Effects:
  • Thrush (oral candidiasis)
  • Hoarseness
  • Upper respiratory tract infections
  • Headache
  • Cough
• Warnings & Cautions:
  • Pneumonia Risk: Inhaled corticosteroids can increase the risk of pneumonia in COPD patients.
  • Adrenal Suppression: Long-term ICS use may suppress adrenal function; monitor if symptoms arise.
  • Local Effects: Rinse mouth after use to minimize local side effects such as oral thrush.
  • Systemic Effects: Although the systemic absorption is low, monitor for potential cardiovascular effects.
• Drug Interactions:
  • Beta‑Blockers: May reduce the bronchodilator effect of vilanterol.
  • Other Respiratory Medications: Concomitant use with other inhaled therapies should be managed to avoid duplicative effects or adverse events.

Reference: U.S. FDA; American Thoracic Society (ATS) guidelines; ClinicalTrials.gov

What drug interactions should be considered with Trelegy Ellipta?

• Beta‑Blockers: Non‑selective beta‑blockers may diminish the bronchodilator response provided by vilanterol.
• Other Inhaled Medications: Use caution when combining with other long‑acting bronchodilators to prevent additive side effects.
• Systemic Corticosteroids: Caution is advised if additional systemic corticosteroid therapy is needed, as this may increase the risk of systemic side effects.

Reference: U.S. FDA; National Institutes of Health (NIH) clinical guidelines

Where can I find additional clinical evidence and detailed information about Trelegy Ellipta?

For more detailed clinical data, dosing guidelines, and safety monitoring information, refer to:

• U.S. Food and Drug Administration (FDA) Website: FDA.gov
• ClinicalTrials.gov: Search for trials involving Trelegy Ellipta (e.g., NCT02164513)
• New England Journal of Medicine (NEJM) and Lancet Respiratory Medicine: For peer‑reviewed studies on triple therapy in COPD
• American Thoracic Society (ATS) Guidelines: ATS.org

Final Thoughts

Trelegy Ellipta represents a significant advancement in the management of chronic obstructive pulmonary disease (and, in some regions, asthma) by combining three complementary mechanisms of action in a single, once‑daily inhaler. Through the anti‑inflammatory effects of fluticasone furoate, the bronchodilatory action of vilanterol, and the anticholinergic effects of umeclidinium, Trelegy Ellipta improves lung function, reduces exacerbations, and enhances quality of life for patients with COPD. Given the potential risks—such as pneumonia and adrenal suppression—its use should be carefully monitored, and proper inhaler technique must be ensured.

Disclaimer: This information is provided for educational purposes only and should not replace professional medical advice. Always consult with your healthcare provider before initiating or modifying any medication regimen.