Dosing & Uses
Dosage Forms & Strengths
powder for inhalation
Chronic Obstructive Pulmonary Disease
Combination anticholinergic/long-acting beta2-adrenergic agonist (LABA) indicated for long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema
62.5 mcg/25 mcg (1 actuation) inhaled PO qDay
Renal impairment (including severe [CrCl <30 mL/min]): No dosage adjustment required
Moderate hepatic impairment (Child-Pugh 7-9): No dosage adjustment required
Severe hepatic impairment: Unknown, not evaluated
Geriatric patients: No dosage adjustment require
Inhaler is not reusable
Store at room temperature between 68-77°F (20-25°C); excursions permitted from 59-86°F (15-30°C)
Store in a dry place away from direct heat or sunlight
Before the inhaler is used for the 1st time, the counter should show the number 30 (7 if a sample or institutional pack); this is the number of doses in the inhaler
See prescribing information for detailed description regarding how to administer
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Pain in extremity (2%)
Muscle spasms (1%)
Neck pain (1%)
Chest pain (1%)
Lower respiratory tract infection (1%)
Musculoskeletal chest pain
Cardiac Disorders : Palpitations
Immune System Disorders: Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria
Nervous System Disorders: Dysgeusia, tremor
Psychiatric Disorders: Anxiety
Black Box Warnings
Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, increase the risk for asthma-related death
A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths; this finding is considered a class effect of all LABA, including vilanterol
Safety and efficacy not established in patients with asthma; NOT approved for treatment of asthma
Severe hypersensitivity to milk proteins
Demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients
Anaphylactic reactions reported in patients with severe milk protein allergy after inhalation of other powder products containing lactose (see Contraindications)
Not indicated for relief of acute bronchospasm or for the treatment of asthma; data from a large placebo-controlled trial in subjects with asthma showed that LABAs may increase the risk of asthma-related death (see Black Box Warnings)
Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD
Beta2-agonists can produce clinically significant cardiovascular effects including increased pulse rate or increased systolic or diastolic blood pressure
Do not exceed recommended dose (ie, 1 actuation once daily) or coadminister with other medicines containing a LABA; may result in overdose
Paradoxical bronchospasm reported; discontinue umeclidinium bromide/vilanterol and treat immediately with an inhaled, prompt-acting bronchodilator (eg, albuterol)
Beta2-agonists should be used with caution with convulsive disorders, thyrotoxicosis, narrow-angle glaucoma, conditions causing urinary retention, and in individuals who are unusually responsive to sympathomimetic amines
Potential for beta2-agonists to produce significant hypokalemia (possibly through intracellular shunting) and transient hyperglycemia (not observed in clinical trials)
Caution with coadministration with strong CYP3A4 inhibitors because increased cardiovascular adverse effects may occur
Use beta2-agonists with extreme caution in patients being treated with MAOIs, TCAs, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Unknown if distributed in human breast milk
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Umeclidinium bromide: Long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic; blocks action of acetylcholine at muscarinic receptors (M1 to M5) in the bronchial airways (M3) by preventing increase in intracellular calcium concentration, leading to relaxation of airway smooth muscle, improved lung function, and decreased mucous secretion; dissociates slowly from M3 muscarinic receptors extending its duration of action
Vilanterol: Long-acting selective beta2-adrenergic agonist (LABA); stimulates intracellular adenyl cyclase resulting in increased cAMP levels causing bronchial smooth muscle relaxation; also inhibits release of mediators of immediate hypersensitivity from cells, especially from mast cells
Plasma levels not predictive of therapeutic effect
Peak plasma time: 5-15 minutes (umeclidinium/vilanterol)
Following IV administration of each component
Protein bound: 89% (umeclidinium); 94% (vilanterol)
Vd: 86 L (umeclidinium); 165 L (vilanterol)
- Primarily metabolized by CYP2D6 and is a substrate for the P-gp transporter
- Primary metabolic routes for umeclidinium are oxidative (hydroxylation, O-dealkylation) followed by conjugation (eg, glucuronidation), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established
- Systemic exposure to the metabolites is low
- Metabolized principally by CYP3A4 and is a substrate for the P-gp transporter
- Metabolized to a range of metabolites with significantly reduced beta1- and beta2-agonist activity
Half-life: 11 hr (umeclidinium/vilanterol)
- Umeclidinium (IV): 58% feces; 22% urine
- Umeclidinium (PO): 92% feces; <1% urine
- Vilanterol (PO): 30% feces; 70% urine
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
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