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Incruse Ellipta

"The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease ("...

Incruse Ellipta

Incruse Ellipta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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 include upper respiratory infection, stuffy or runny nose, cough, sore throat, joint pain, muscle pain, tooth pain, stomach pain, bruising or dark areas of skin, and fast or irregular heartbeat.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Incruse Ellipta FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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