STEPS

New Drug Reviews

Glycopyrrolate (Seebri Neohaler) for Maintenance Therapy in Patients with COPD

 

Am Fam Physician. 2017 Sep 15;96(6):395-398.

Glycopyrrolate (Seebri Neohaler) is an inhaled long-acting muscarinic antagonist agent labeled for maintenance treatment in patients diagnosed with chronic obstructive pulmonary disease (COPD).13

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DrugDosageDose formCost*

Glycopyrrolate (Seebri Neohaler)

15.6 mcg inhaled twice a day

15.6-mcg capsule

$419


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed August 4, 2017).

DrugDosageDose formCost*

Glycopyrrolate (Seebri Neohaler)

15.6 mcg inhaled twice a day

15.6-mcg capsule

$419


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed August 4, 2017).

SAFETY

Because glycopyrrolate does not reverse acute bronchospasm, it should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD. Glycopyrrolate should also not be used for the relief of acute symptoms. In addition, it may worsen anticholinergic symptoms such as urinary retention; narrow-angle glaucoma and paradoxical bronchospasm may occur. The use of glycopyrrolate should be discontinued if any of these problems develop. Clinical studies excluded patients who had a history of these conditions.

Glycopyrrolate has not been studied in women who are pregnant or breastfeeding. It is a U.S. Food and Drug Administration pregnancy category C drug.

TOLERABILITY

Glycopyrrolate is generally well tolerated with infrequent adverse effects (less than 2% to 3%), and dropout rates were comparable to those reported with placebo. Some patients (less than 5%) reported experiencing mild dry mouth, upper respiratory tract infection (number needed to harm = 91), and nasopharyngitis (number needed to harm = 500).3,4

EFFECTIVENESS

No long-term research has evaluated the effect of glycopyrrolate on mortality. In clinical studies comparing glycopyrrolate with placebo, patients with moderate to severe COPD (2008 Global Initiative for Chronic Obstructive Lung Disease [GOLD] class 2 or 3) had a decreased need for albuterol and a lower likelihood of COPD

Address correspondence to Clinton K. Pong, MD, at cpong@challiance.org. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

REFERENCES

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1. Ulrik CS. Once-daily glycopyrronium bromide, a long-acting muscarinic antagonist, for chronic obstructive pulmonary disease: a systematic review of clinical benefit. Int J Chron Obstruct Pulmon Dis. 2012;7673–678....

2. U.S. Food and Drug Administration. Drug Approval Package: Seebri Neohaler (glycopyrrolate). 12/6/16. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207923Orig1_toc.cfm. Accessed March 6, 2017.

3. DailyMed. Drug label information: Seebri Neohaler—glycopyrrolate capsule. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8839674f-26d6-4302-9da0-258decfba9aa. Accessed March 6, 2017.

4. D'Urzo A, Ferguson GT, van Noord JA, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011;12156.

5. Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):199–209.

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.

This 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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