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Anoro Ellipta

Last reviewed on RxList: 6/19/2019
Anoro Ellipta Side Effects Center

Last reviewed on RxList 6/19/2019

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 of Anoro Ellipta include:

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.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Anoro Ellipta Professional Information

SIDE EFFECTS

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

  • Serious asthma-related events–hospitalizations, intubations, death. LABA, such as vilanterol (one of the active ingredients in ANORO ELLIPTA), as monotherapy (without ICS) for asthma increase the risk of asthma-related events. ANORO ELLIPTA is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS].
  • 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 two 12-month trials. Adverse reactions observed in the other trials were similar to those observed in the confirmatory trials.

6-Month Trials

The incidence of adverse reactions associated with ANORO ELLIPTA in Table 1 is based on four 6-month trials: 2 placebo-controlled trials (Trial 1, NCT #01313650 and Trial 2 NCT #01313637); N = 1,532 and N = 1,489, respectively) and 2 active-controlled trials (Trial 3, NCT #01316900 and Trial 4, NCT #01316913); N = 843 and N = 869, respectively). Of the 4,733 subjects, 68% were male and 84% were white. 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 postbronchodilator percent predicted forced expiratory volume in 1 second (FEV1) was 48% (range: 13% to 76%), the mean postbronchodilator 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 Placebo in Subjects with Chronic Obstructive Pulmonary Disease

Adverse Reaction ANORO
ELLIPTA
(n = 842)
%
Umeclidinium
62.5 mcg
(n = 418)
%
Vilanterol
25 mcg
(n = 1,034)
%
Placebo
(n = 555)
%
Infections and infestations
  Pharyngitis 2 1 2 <1
  Sinusitis 1 <1 1 <1
  Lower respiratory tract infection 1 <1 <1 <1
Gastrointestinal disorders
  Constipation 1 <1 <1 <1
  Diarrhea 2 <1 2 1
Musculoskeletal and connective tissue disorders
  Pain in extremity 2 <1 2 1
  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 <1% but more common than 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.

12-Month Trials

In a long-term safety trial (Trial 5, NCT #01316887), 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 observed with a frequency of ≥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.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of ANORO 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 ANORO ELLIPTA or a combination of these factors.

Cardiac Disorders Palpitations.

Eye Disorders Blurred vision, glaucoma, increased intraocular pressure.

Immune System Disorders Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria.

Nervous System Disorders Dysgeusia, tremor.

Psychiatric Disorders Anxiety.

Renal and Urinary Disorders Dysuria, urinary retention.

Respiratory, Thoracic, and Mediastinal Disorders Dysphonia, paradoxical bronchospasm.

Read the entire FDA prescribing information for Anoro Ellipta (Umeclidinium and Vilanterol Inhalation Powder)

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

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