Welcome to the latest edition of our Guidelines+ Monographs Series. In this installment, we will delve into the medication fluticasone furoate, umeclidinium, and vilanterol, marketed under the brand name Trelegy Ellipta by GlaxoSmithKline. Trelegy Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and the maintenance treatment of asthma in patients aged 18 years and older. It was initially approved in 2017.
In the following sections, we will provide a comprehensive overview of fluticasone furoate, umeclidinium, and vilanterol and analyze its positioning across various guidelines for its approved indications.
Note* – This Guidelines+ Monographs for fluticasone furoate, umeclidinium, and vilanterol (Trelegy Ellipta) is current as of November 2024. Consult our clinical guidelines library and/or or medication information lookup tool to ensure you are always accessing the most current information.
Medication Overview:
- Brand name: Trelegy Ellipta
- Generic name: fluticasone furoate, umeclidinium, and vilanterol
- Manufacturer(s): GlaxoSmithKline
- Initial FDA Approval: September 2017
Indications and FDA Approval Details
| Indicated Condition | Indicated | Age Range | Date Approved |
|---|---|---|---|
| COPD | For the maintenance treatment of patients with COPD. | Adults | September 2017 |
| Asthma | For the maintenance treatment of asthma. | Adults | September 2020 |
Dosage and Administration
- For oral inhalation only.
- Maintenance treatment of COPD: 1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg once daily administered by oral inhalation.
- Maintenance treatment of asthma: 1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg or TRELEGY ELLIPTA 200/62.5/25 mcg once daily administered by oral inhalation.
Warnings and Precautions
- LABA monotherapy increases the risk of serious asthma-related events.
- Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms.
- Do not use in combination with additional therapy containing a LABA because of risk of overdose.
- Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
- Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia.
- Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
- Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to TRELEGY ELLIPTA.
- Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue TRELEGY ELLIPTA slowly.
- If paradoxical bronchospasm occurs, discontinue TRELEGY ELLIPTA and institute alternative therapy.
- Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
- Assess for decrease in bone mineral density initially and periodically thereafter.
- Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY ELLIPTA long term.
- Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.
- Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
- Be alert to hypokalemia and hyperglycemia.
Adverse Reactions
- COPD: Most common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.
- Asthma: Most common adverse reactions (incidence ≥2%) are pharyngitis/nasopharyngitis, upper respiratory tract infection/viral upper respiratory tract infection, bronchitis, respiratory tract infection/viral respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, influenza, headache, and back pain.
Now that we’ve covered the basic monograph information for Trelegy Ellipta, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Fluticasone Furoate, Umeclidinium, & Vilanterol in Clinical Guidelines
- Global Strategy for Asthma Management and Prevention 2024
- Authoring Society: Global Initiative for Asthma (GINA)
- Publication Date: May 2024
- Dupilumab-Related Recommendation(s):
- Fluticasone furoate, umeclidinium, and vilanterol inhaler may be considered for patients 18 and up if asthma is persistently uncontrolled despite medium or high dose ICS-LABA.
- Management of Chronic Obstructive Pulmonary Disease (COPD)
- Veterans Health Administration / Department of Defense (VA/DoD)
- Publication: April 01, 2021
- Under the section Inhaled Corticosteroids (ICS) + Long-Acting Beta 2-Agonist (LABA) + Products Fluticasone furoate/Vilanterol/ Umeclidinium (Trelegy Ellipta) is recommended
- Pharmacologic Management of Chronic Obstructive Pulmonary Disease
- American Thoracic Society (ATS)
- Publication: April 01, 2020
- In patients with COPD who complain of dyspnea or exercise intolerance despite dual therapy with LABA/LAMA, ATS suggests the use of triple therapy with inhaled corticosteroids (ICS)/LABA/LAMA over dual therapy with LABA/LAMA in those patients with history of one or more exacerbations in the past year requiring antibiotics or oral steroids or hospitalization.
This concludes our Guidelines+ Monographs for fluticasone furoate, umeclidinium, & vilanterol inhalation powder (Trelegy Ellipta). This list is current as of November 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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