Vilanterol / Fluticasone Furoate

What it is and how it works

Mechanism of Action Fluticasone Furoate/Vilanterol ELLIPTA Fluticasone Furoate/Vilanterol ELLIPTA contains both fluticasone furoate and vilanterol. The mechanisms of action described below for the individual components apply to Fluticasone Furoate/Vilanterol ELLIPTA. These drugs represent 2 different classes of medications (an ICS and a LABA), each having different effects on clinical and physiological indices. Fluticasone Furoate Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity.

Indications

Fluticasone Furoate/Vilanterol ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long‑acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). • the maintenance treatment of asthma in patients aged 5 years and older. Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1.3 , 5.2 ) Maintenance Treatment of Chronic Obstructive Pulmonary Disease Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Maintenance Treatment of Asthma Fluticasone Furoate/Vilanterol ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 5 years and older. Limitations of Use Fluticasone Furoate/Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm.

Dosage and administration (summary)

• For oral inhalation only. • Maintenance treatment of COPD: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg once daily administered by oral inhalation. • Maintenance treatment of asthma in adult patients aged 18 years and older: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg or Fluticasone Furoate/Vilanterol ELLIPTA 200/25 mcg once daily administered by oral inhalation. • Maintenance treatment of asthma in pediatric patients aged 12 to 17 years: 1 actuation of Fluticasone Furoate/Vilanterol ELLIPTA 100/25 mcg once daily administered by oral inhalation.

Contraindications

Fluticasone Furoate/Vilanterol ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients . • Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures.

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.

Pregnancy

Pregnancy Risk Summary There are insufficient data on the use of fluticasone furoate/vilanterol ELLIPTA or its individual components, fluticasone furoate and vilanterol, in pregnant women to inform a drug-associated risk.

Storage and supply

Fluticasone Furoate/Vilanterol ELLIPTA is supplied as a disposable light grey and pale blue plastic inhaler containing 2 foil strips, each with 30 blisters. One strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose.

Source: Fluticasone Furoate And Vilanterol (Fluticasone Furoate And Vilanterol) — US FDA prescribing information, 2024-11-21, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.