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Incruse Ellipta

Last reviewed on RxList: 6/26/2017
Incruse Ellipta Side Effects Center

Last reviewed on RxList 6/26/2017

Incruse Ellipta (umeclidinium) Inhalation Powder is an anticholinergic drug used for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Common side effects of Incruse Ellipta include:

Incruse Ellipta (umeclidinium 62.5 mcg) should be administered as 1 inhalation dose once daily by the orally inhaled route only. Incruse Ellipta may interact with other anticholinergic drugs. Tell your doctor all medications and supplements you use. During pregnancy, Incruse Ellipta should be taken only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Incruse Ellipta (umeclidinium) Inhalation Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Incruse Ellipta Professional Information

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.

In the 8 clinical trials conducted to support initial approval of INCRUSE ELLIPTA, a total of 1,663 subjects with COPD (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 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.

The safety and efficacy of INCRUSE ELLIPTA in combination with an inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) were also evaluated in four 12-week clinical trials. A total of 1,637 subjects with COPD across four 12-week, randomized, double-blind clinical trials received at least 1 dose of INCRUSE ELLIPTA (62.5 mcg) or placebo administered once daily in addition to background ICS/LABA (mean age: 64 years, 88% white, 65% male across all treatments). Two trials (Trials 1 and 2) evaluated INCRUSE ELLIPTA in combination with fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg administered once daily, and 2 trials (Trials 3 and 4) evaluated INCRUSE ELLIPTA administered once daily in combination with fluticasone propionate/salmeterol (FP/SAL) 250 mcg/50 mcg administered twice daily [see Clinical Studies]. Adverse reactions that occured with INCRUSE ELLIPTA in combination with an ICS/LABA were similar to those reported with INCRUSE ELLIPTA as monotherapy. In addition to the umeclidinium monotherapy adverse reactions reported above, adverse reactions occurring with INCRUSE ELLIPTA in combination with an ICS/LABA, at an incidence of greater than or equal to 1% and exceeding ICS/LABA alone, were oropharyngeal pain and dysgeusia.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of INCRUSE ELLIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to INCRUSE ELLIPTA or a combination of these factors.

Immune System Disorders

Hypersensitivity reactions, including anaphylaxis, angioedema, pruritus, and urticaria.

Read the entire FDA prescribing information for Incruse Ellipta (Umeclidinium Inhalation Powder)

Related Resources for Incruse Ellipta

© Incruse Ellipta Patient Information is supplied by Cerner Multum, Inc. and Incruse Ellipta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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