Umeclidinium / Vilanterol

What it is and how it works

Mechanism of Action Umeclidinium and Vilanterol ELLIPTA Umeclidinium and Vilanterol ELLIPTA contains both umeclidinium and vilanterol. The mechanisms of action described below for the individual components apply to Umeclidinium and Vilanterol ELLIPTA. These drugs represent 2 different classes of medications (an anticholinergic and a LABA) each having different effects on clinical and physiological indices. Umeclidinium Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5.

Indications

Umeclidinium and Vilanterol ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use Umeclidinium and Vilanterol ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of Umeclidinium and Vilanterol ELLIPTA in asthma have not been established. Umeclidinium and Vilanterol ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: Not indicated for relief of acute bronchospasm or for the treatment of asthma. ( 1 , 5.2 )

Dosage and administration (summary)

The recommended dosage of Umeclidinium and Vilanterol ELLIPTA for maintenance treatment of COPD is 62.5 mcg umeclidinium and 25 mcg vilanterol (1 actuation of Umeclidinium and Vilanterol ELLIPTA 62.5/25 mcg) once daily by oral inhalation. • Umeclidinium and Vilanterol ELLIPTA should be used at the same time every day. Do not use Umeclidinium and Vilanterol ELLIPTA more than 1 time every 24 hours. • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment . • For oral inhalation only. • Maintenance treatment of COPD: 1 actuation of Umeclidinium and Vilanterol ELLIPTA once daily administered by oral inhalation.

Contraindications

Umeclidinium and Vilanterol ELLIPTA is contraindicated in: • patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients . • use of a long-acting beta 2 -adrenergic agonist (LABA), including vilanterol, one of the active ingredients in Umeclidinium and Vilanterol ELLIPTA, without an inhaled corticosteroid (ICS), in patients with asthma .

Warnings and precautions

• LABA monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. • Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms. • Do not use in combination with additional therapy containing a LABA because of risk of overdose. • If paradoxical bronchospasm occurs, discontinue Umeclidinium and Vilanterol ELLIPTA and institute alternative therapy. • Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.

Pregnancy

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

Storage and supply

Umeclidinium and Vilanterol ELLIPTA is supplied as a disposable light grey and red plastic inhaler containing 2 foil strips, each with 30 blisters. One strip contains umeclidinium (62.5 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: Umeclidinium Bromide And Vilanterol Trifenatate (Umeclidinium And Vilanterol Ellipta) — US FDA prescribing information, 2024-11-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.