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Incruse Ellipta

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Incruse Ellipta

SIDE EFFECTS

The following adverse reactions are described in greater detail in other sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 1,663 subjects with COPD across 8 clinical trials (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg. In the 4 randomized, double-blind, placebo- or active-controlled efficacy clinical trials, 1,185 subjects received umeclidinium for up to 24 weeks, of which 487 subjects received the recommended dose of umeclidinium 62.5 mcg. In a 12-month, randomized, double-blind, placebo-controlled, long-term safety trial, 227 subjects received umeclidinium 125 mcg for up to 52 weeks [see Clinical Studies].

The incidence of adverse reactions associated with INCRUSE ELLIPTA in Table 1 is based upon 2 placebo-controlled efficacy trials: one 12-week trial and one 24-week trial.

Table 1: Adverse Reactions With INCRUSE ELLIPTA With ≥ 1% Incidence and More Common Than With Placebo in Subjects With Chronic Obstructive Pulmonary Disease

Adverse Reaction INCRUSE ELLIPTA
(n = 487) %
Placebo
(n = 348) %
Infections and infestations
  Nasopharyngitis 8% 7%
  Upper respiratory tract infection 5% 4%
  Pharyngitis 1% < 1%
  Viral upper respiratory tract infection 1% < 1%
Respiratory, thoracic, and mediastinal disorders
  Cough 3% 2%
Musculoskeletal and connective tissue disorders
  Arthralgia 2% 1%
  Myalgia 1% < 1%
Gastrointestinal disorders
  Abdominal pain upper 1% < 1%
  Toothache 1% < 1%
Injury, poisoning, and procedural complications
  Contusion 1% < 1%
  Cardiac disorders Tachycardia 1% < 1%

Other adverse reactions with INCRUSE ELLIPTA observed with an incidence less than 1% but more common than placebo included atrial fibrillation.

In a long-term safety trial, 336 subjects (n = 227 umeclidinium 125 mcg, n = 109 placebo) were treated for up to 52 weeks with umeclidinium 125 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the efficacy trials described above. Adverse reactions that occurred with a frequency greater than or equal to 1% in subjects receiving umeclidinium 125 mcg that exceeded that in placebo in this trial were: nasopharyngitis, upper respiratory tract infection, urinary tract infection, pharyngitis, pneumonia, lower respiratory tract infection, rhinitis, supraventricular tachycardia, supraventricular extrasystoles, sinus tachycardia, idioventricular rhythm, headache, dizziness, sinus headache, cough, back pain, arthralgia, pain in extremity, neck pain, myalgia, nausea, dyspepsia, diarrhea, rash, depression, and vertigo.

Read the Incruse Ellipta (umeclidinium inhalation powder) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Anticholinergics

There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of INCRUSE ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

Last reviewed on RxList: 5/19/2014
This monograph has been modified to include the generic and brand name in many instances.

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