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AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000445686.75424.bf
Drug Watch

New Drug Approved to Treat COPD

Aschenbrenner, Diane S. MS, RN

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Author Information

Diane S. Aschenbrenner recently retired as course coordinator for undergraduate pharmacology at Johns Hopkins University School of Nursing in Baltimore, MD. She also coordinates Drug Watch : daschen1@jhu.edu.

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Abstract

* Umeclidinium and vilanterol inhalation powder (Anoro Ellipta) is a new drug for treating chronic obstructive pulmonary disease.

* It's used once daily for long-term maintenance and cannot be used to treat acute bronchospasm or asthma.

* As a combination of an anticholinergic and a long-acting b2-agonist, Anoro Ellipta carries the same warnings regarding drug–drug interactions and adverse effects as other drugs in those classes.

The Food and Drug Administration (FDA) has approved a new drug, umeclidinium and vilanterol inhalation powder (Anoro Ellipta), for the treatment of chronic obstructive pulmonary disease (COPD). Anoro Ellipta is used once daily for long-term maintenance; it cannot be used during an acute exacerbation of COPD, such as acute bronchospasm.

Umeclidinium is an anticholinergic; it blocks the effects of acetylcholine, which prevents stimulation of the parasympathetic nervous system, thereby helping the muscles around the large airways to relax and preventing bronchoconstriction. Vilanterol is a long-acting b2-agonist (LABA) that stimulates the sympathetic nervous system. b2-receptors are located primarily in the lungs; stimulation of these receptors produces bronchial dilation and greater depth of respiration. Drugs like vilanterol, which specifically target b2-receptors, have minimal effect on the cardiovascular system in most patients, despite being sympathomimetics.

As with all LABAs, Anoro Ellipta's labeling carries a boxed warning that the drug increases the risk of asthma-related death. The warning is based on studies of the LABA salmeterol, and the risk is considered a class effect of LABAs. The safety and efficacy of Anoro Ellipta haven't been established in patients with asthma, and the drug isn't approved for use in such patients. Anoro Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins because the product contains lactose.

Like other anticholinergic drugs, Anoro Ellipta can worsen urinary retention, narrow-angle glaucoma, and cardiovascular disorders (such as coronary insufficiency, arrhythmias, and hypertension), so caution must be used if administering the drug to patients with any of these conditions. b2-receptor stimulation can produce cardiac stimulation in certain susceptible patients, which increases the risks of tachycardia and hypertension. As with the use of other b2-agonists and other sympathomimetic drugs, Anoro Ellipta use requires caution in patients with a history of convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathetic stimulation. Like other b-agonists (specific and nonspecific for b2-receptors), Anoro Ellipta can induce hypokalemia and hyperglycemia. These are usually transient and don't require treatment, although they may be significant in some patients. And as with other LABAs and other inhaled medicines, Anoro Ellipta's labeling carries a warning that the drug might induce paradoxical bronchospasm. Caution is required when using Anoro Ellipta if any of the above conditions is present.

Anoro Ellipta is generally well tolerated. The most common adverse effects are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in the extremities, muscle spasms, neck pain, and chest pain.

Several drug–drug interactions are possible. Anoro Ellipta should not be used in combination with any other LABA-containing drug because overstimulation of b2-receptors can result in significant adverse effects. Using Anoro Ellipta more frequently than prescribed or in larger doses than recommended may also produce overstimulation of the b2-receptors, reflexive bronchoconstriction, and other adverse effects. In contrast, concurrent use of b-blockers will lessen the therapeutic effect of Anoro Ellipta. Anoro Ellipta shouldn't be used with other anticholinergic drugs, either, because that can produce severe anticholinergic effects. Because the vilanterol component of Anoro Ellipta is a substrate of the cytochrome P-450 (CYP) isoenzyme CYP3A4 (meaning that it's metabolized by this isoenzyme), a drug interaction can occur if Anoro Ellipta is coadministered with drugs that are strong inhibitors of CYP3A4 (such as ketoconazole, ritonavir, and clarithromycin, among others); less effective CYP3A4 metabolism will increase circulating levels of Anoro Ellipta and the risk of adverse effects.

As with other b2-agonists, the effect of Anoro Ellipta on the cardiovascular system can be greatly increased if the drug is coadministered with monoamine oxidase inhibitors (such as phenelzine), tricyclic antidepressants (such as nortriptyline), or any drug known to prolong the QT interval. Coadministration with diuretics that promote potassium loss increases the risk of hypokalemia.

Nurses working with patients taking Anoro Ellipta should take a thorough drug history to confirm that they're not taking other medications that could produce drug interactions or adverse effects. Nurses should confirm that patients aren't taking another LABA. They should also instruct patients to avoid over-the-counter antihistamines. Patients should be taught how to use the drug safely and effectively. If a patient is switching from a short-acting b2-agonist (such as albuterol), used multiple times daily, to Anoro Ellipta, used once daily, the nurse should confirm that the patient knows to use the short-acting drug only if symptoms appear. Patient education should also stress that Anoro Ellipta is a maintenance drug taken only once daily and is not a rescue drug. Nurses should instruct patients to keep the foil blisters in which individual doses are packaged closed until the time of use to prevent moisture from damaging the medication. They should also explain that the inhaler accompanying the medication is disposable and shouldn't be reused.

For complete FDA prescribing information for Anoro Ellipta, go to http://1.usa.gov/1d2JWVH.

© 2014 Lippincott Williams & Wilkins. All rights reserved.

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