Umeclidinium/​Vilanterol

DEA Class; Rx

Common Brand Names; Anoro Ellipta

• Anticholinergics, Respiratory; 
• Beta2 Agonists; 
• Respiratory Inhalant Combos

Severe hypersensitivity to milk proteins

Demonstrated hypersensitivity to umeclidinium, vilanterol, or excipients

Use without an inhaled corticosteroid in the treatment of asthma

• Pharyngitis (2%)
• Diarrhea (2%)
• Pain in extremity (2%)
• Muscle spasms (1%)
• Neck pain (1%)
• Chest pain (1%)
• Sinusitis (1%)
• Lower respiratory tract infection (1%)
• Constipation (1%)
• Productive cough
• Dry mouth
• Dyspepsia
• Abdominal pain
• GERD
• Vomiting
• Musculoskeletal chest pain
• Chest discomfort
• Asthenia
• Atrial fibrillation
• Ventricular extrasystoles
• Supraventricular extrasystoles
• Myocardial infarction
• Pruritus
• Rash
• Conjunctivitis

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

Do not exceed recommended dose (ie, 1 actuation once daily) or coadminister with other medicines containing a LABA; may result in overdose

Fatalities reported in association with excessive use of inhaled sympathomimetic drugs

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, and in individuals who are unusually responsive to sympathomimetic amines; instruct patients to consult a healthcare provider immediately if any worsening of narrow-angle glaucoma develops

Prescribers and patients should be alert for signs and symptoms of urinary retention (eg, difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction; instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develop

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

Use during pregnancy only if potential benefit justifies potential risk to fetus; women should be advised to contact their healthcare providers if they become pregnant while receiving therapy; use during late gestation and labor only if the potential benefit justifies potential risks related to beta-agonists interfering with uterine contractility

There is no information available on presence of umeclidinium or vilanterol in human milk, effects on breastfed child, or on milk production

Umeclidinium bromide/vilanterol inhaled

powder for inhalation

• (62.5mcg/25mcg)/actuation