"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 ("...
- Clinician Information:
Anoro Ellipta Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Anoro Ellipta (umeclidinium and vilanterol) Inhalation Powder is a combination anticholinergic and long acting beta-adrenoceptor agonist (LABA) 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 sore throat, sinusitis, respiratory tract infection, constipation, diarrhea, pain in extremities, muscle spasms, neck pain, and chest pain.
Anoro Ellipta is administered as 1 inhalation dose once daily by the orally inhaled route only. Anoro Ellipta may interact with monoamine oxidase inhibitors (MAOIs), antidepressants, beta‐blockers, diuretics, and other anticholinergic drugs. Tell your doctor all medications and supplements you use. During pregnancy, Anoro Ellipta should be used only if prescribed. Tell your doctor if you are pregnant before taking Anoro Ellipta or if you become pregnant during treatment. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Anoro Ellipta (umeclidinium and vilanterol) 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.
Anoro Ellipta FDA Prescribing Information: Side Effects
LABA, such as vilanterol, one of the active ingredients in ANORO ELLIPTA, increase the risk of asthma-related death. ANORO ELLIPTA is not indicated for the treatment of asthma. [See BOXED WARNING and WARNINGS AND PRECAUTIONS]
The following adverse reactions are described in greater detail in other sections:
- Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
- Cardiovascular effects [see WARNINGS AND PRECAUTIONS]
- Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
- Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]
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.
The clinical program for ANORO ELLIPTA included 8,138 subjects with COPD in four 6-month lung function trials, one 12-month long-term safety study, and 9 other trials of shorter duration. A total of 1,124 subjects have received at least 1 dose of ANORO ELLIPTA (umeclidinium/vilanterol 62.5 mcg/25 mcg), and 1,330 subjects have received a higher dose of umeclidinium/vilanterol (125 mcg/25 mcg). The safety data described below are based on the four 6-month and the one 12-month trials. Adverse reactions observed in the other trials were similar to those observed in the confirmatory trials.
The incidence of adverse reactions associated with ANORO ELLIPTA in Table 1 is based on four 6-month trials: 2 placebo-controlled trials (Trials 1 and 2; n = 1,532 and n = 1,489, respectively) and 2 active-controlled trials (Trials 3 and 4; n = 843 and n = 869, respectively). Of the 4,733 subjects, 68% were male and 84% were Caucasian. They had a mean age of 63 years and an average smoking history of 45 pack-years, with 50% identified as current smokers. At screening, the mean post-bronchodilator percent predicted forced expiratory volume in 1 second (FEV1) was 48% (range: 13% to 76%), the mean post-bronchodilator FEV1/forced vital capacity (FVC) ratio was 0.47 (range: 0.13 to 0.78), and the mean percent reversibility was 14% (range: -45% to 109%).
Subjects received 1 dose once daily of the following: ANORO ELLIPTA, umeclidinium/vilanterol 125 mcg/25 mcg, umeclidinium 62.5 mcg, umeclidinium 125 mcg, vilanterol 25 mcg, active control, or placebo.
Table 1: Adverse Reactions With ANORO ELLIPTA With
≥ 1% Incidence and More Common Than With Placebo in Subjects With Chronic
Obstructive Pulmonary Disease
(n = 555)
(n = 842)
|Umeclidinium 62.5 mcg
(n = 418)
|Vilanterol 25 mcg
(n = 1,034)
|Infections and infestations|
|Sinusitis||< 1||1||< 1||1|
|Lower respiratory tract infection||< 1||1||< 1||< 1|
|Constipation||< 1||1||< 1||< 1|
|Musculoskeletal and connective tissue disorders|
|Pain in extremity||1||2||< 1||2|
|Muscle spasms||< 1||1||< 1||< 1|
|Neck pain||< 1||1||< 1||< 1|
|General disorders and administration site conditions|
|Chest pain||< 1||1||< 1||< 1|
Other adverse reactions with ANORO ELLIPTA observed with an incidence less than 1% but more common than with placebo included the following: productive cough, dry mouth, dyspepsia, abdominal pain, gastroesophageal reflux disease, vomiting, musculoskeletal chest pain, chest discomfort, asthenia, atrial fibrillation, ventricular extrasystoles, supraventricular extrasystoles, myocardial infarction, pruritus, rash, and conjunctivitis.
In a long-term safety trial, 335 subjects were treated for up to 12 months with umeclidinium/vilanterol 125 mcg/25 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled efficacy trials described above. Adverse reactions that occurred with a frequency of greater than or equal to 1% in the group receiving umeclidinium/vilanterol 125 mcg/25 mcg that exceeded that in placebo in this trial were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus.
Read the entire FDA prescribing information for Anoro Ellipta (Umeclidinium and Vilanterol Inhalation Powder) »
Additional Anoro Ellipta Information
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