Umeclidinium and Vilanterol (Inhalation)
Brand Name: Anoro Ellipta
Common Dosage Forms:
Inhalation Powder: Each inhaled dose delivers the contents of two foil blisters, one containing 62.5 mcg umeclidinium and the other containing 25 mcg vilanterol. The actual delivered dose is patient dependent.
FDA Indications/Dosages:
For the long-term once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD): One inhalation of Anoro Ellipta once daily.
Monitor: K
Pharmacology/Pharmacokinetics: Umeclidinium bromide is a long-acting antimuscarinic agent. Inhibition of the M3 receptor in the airways leads to bronchodilation. Vilanterol trifenatate is a long-acting beta-2-adrenergic agonist. Vilanterol stimulates adenyl cyclase, the enzyme which catalyzes the formation of cAMP (cyclic 3’5’ adenosine monophosphate) from ATP (adenosine triphosphate). Increased cAMP is associated with relaxation of bronchial, uterine, and to a lesser extent, vascular smooth muscle through stimulation of beta-2-adrenergic receptors. In addition, increased cAMP levels inhibit the release of mediators of immediate hypersensitivity from cells, especially from mast cells. Absorption of both active ingredients does occur through the lung with steady state levels reached in 14 days, however, most of the effects are site-specific to the lung. Metabolism occurs primarily through the CYP2D6 (umeclidinium) and CYP3A4 isoenzyme (vilanterol).
Drug Interactions: Increased cardiovascular effects may occur when given with STRONG CYP3A4 INHIBITORS (ketoconazole, clarithromycin, ritonavir). Use with caution when using within 2 weeks of monoamine oxidase inhibitors, tricyclic antidepressants, or drugs which may prolong the QTc interval. May worsen the effects of hypokalemia when used with loop or thiazide diuretics. Additive adverse effects may be seen when used with other anticholinergics.
Contraindications/Precautions: Contraindicated in patients allergic to milk proteins or other ingredients in Alloro Ellipta. Long-acting beta-2-adrenergic agents (LABA) increase the risk of asthma-related death. Do not initiate in acutely deteriorating COPD or to treat acute symptoms. Do not use in combination with other LABA because of risk of overdose. If paradoxical bronchospasm occurs, discontinue use and institute alternative therapy. Use with caution in patients with cardiovascular disorders. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. Worsening of narrow-angle glaucoma may occur. Worsening of narrow-angle glaucoma. Use with caution in patients with prostatic hyperplasia or bladder neck obstruction. Pregnancy Category C.
Adverse Effects: Most common adverse reactions include pharyngitis, sinusitis, lower respiratory tract infections, constipation, diarrhea, pain in extremities, muscle spasm, neck pain, and chest pain.
Patient Consultation:
Properly train patients on how to use the breath activated Ellipta device.
If a dose is missed, skip it and return to normal dosing schedule.
Not intended to provide immediate relief of bronchospasm.
To receive the full benefits of therapy, use on a regular basis. Although benefits can be seen after 2 days of treatment, up to 4 weeks may be needed to observe benefits.
Contact a physician if the above side effects are severe or persistent or if the effectiveness of short-acting beta-2-agonists decreases.
Contact a physician if symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos) or urinary retention (e.g., difficulty passing urine, painful urination) occur.