STEPS

New Drug Reviews

Umeclidinium (Incruse Ellipta) for COPD

 

Am Fam Physician. 2017 Jan 15;95(2):120-121.

Umeclidinium inhalation powder (Incruse Ellipta) is a long-acting anticholinergic medication labeled for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis.1

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DrugDosageDose formCost*

Umeclidinium (Incruse Ellipta)

One inhalation (62.5 mcg) daily; no titration required

Inhaler preloaded with one-dose blisters of dry powder medication

$315


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed November 3, 2016).

DrugDosageDose formCost*

Umeclidinium (Incruse Ellipta)

One inhalation (62.5 mcg) daily; no titration required

Inhaler preloaded with one-dose blisters of dry powder medication

$315


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed November 3, 2016).

SAFETY

Umeclidinium is a relatively safe medication with few systemic adverse effects. As with aclidinium (Tudorza Pressair), umeclidinium powder contains lactose and should not be used by patients with severe milk protein allergy because anaphylactic reactions have been reported. Similar to other anticholinergic medications, umeclidinium can theoretically cause paradoxical bronchospasm, urinary retention, and cardiac effects.1 Adverse effects with umeclidinium monotherapy are similar to those of umeclidinium combined with an inhaled corticosteroid and a long-acting beta-2 adrenergic agonist.1 Trials assessing adverse effects for umeclidinium included a relatively small number of patients (n = 576) and are therefore underpowered for rare but potentially important harms. Umeclidinium has not been studied in pregnant women, and it is unknown whether it is excreted in breast milk. It is a pregnancy risk category C.1

TOLERABILITY

Umeclidinium is fairly well tolerated. The most common adverse effects are nasopharyngitis (8% vs. 7% with placebo), upper respiratory tract infection (5% vs. 4%), cough (3% vs. 2%), and arthralgia (2% vs. 1%).1 In clinical trials, the drop-out rate was 7%, compared with 4% of the

Address correspondence to R. Christopher Durigan, PharmD, BCPS, at rcdurigan@gmail.com. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

REFERENCES

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1. DailyMed. Drug label information: Incruse Ellipta—umeclidinium aerosol, powder. Research Triangle Park, N.C.: GlaxoSmithKline; 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dbb64747-1505-49d7-9a33-99dd402e96d3#section-1. Accessed June 18, 2016....

2. Center for Drug Evaluation and Research. Medical review. Umeclidinium. 2013. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205382Orig1s000MedR.pdf. Accessed June 18, 2016.

3. Pleasants RA, Wang T, Gao J, Tang H, Donohue JF. Inhaled umeclidinium in COPD patients: a review and meta-analysis. Drugs. 2016;76(3):343–361.

4. Ismaila AS, Huisman EL, Punekar YS, Karabis A. Comparative efficacy of long-acting muscarinic antagonist monotherapies in COPD: a systematic review and network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2015;10:2495–2517.

5. Feldman G, Maltais F, Khindri S, et al. A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 μg compared with tiotropium 18 μg in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:719–730.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.


 

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