Anoro Ellipta Side Effects Center

Last updated on RxList: 10/31/2022
Anoro Ellipta Side Effects Center

What Is Anoro Ellipta?

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.

What Are Side Effects of Anoro Ellipta?

Anoro Ellipta may cause serious side effects including:

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Anoro Ellipta include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Anoro Ellipta

Anoro Ellipta is administered as 1 inhalation dose once daily by the orally inhaled route only.

What Drugs, Substances, or Supplements Interact with Anoro Ellipta?

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.

Anoro Ellipta During Pregnancy and Breastfeeding

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.

Additional Information

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.

SLIDESHOW

COPD Foods to Boost Your Health - COPD Diet Tips See Slideshow
Anoro Ellipta Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • painful or difficult urination, or urinating more often;
  • blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
  • high blood sugar--increased thirst or urination, hunger, dry mouth, fruity breath odor; or
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • stuffy nose, sinus pain, sore throat;
  • chest pain, cough;
  • diarrhea, constipation;
  • muscle spasms; or
  • pain in your neck, arms, or legs.

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 one 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 Trial

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.

DRUG INTERACTIONS

Inhibitors Of Cytochrome P450 3A4

Vilanterol, a component of ANORO ELLIPTA, is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to vilanterol. Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

Monoamine Oxidase Inhibitors And Tricyclic Antidepressants

Vilanterol, like other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.

Beta-adrenergic Receptor Blocking Agents

Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, a component of ANORO ELLIPTA, but may also produce severe bronchospasm in patients with COPD. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.

Non-Potassium-Sparing Diuretics

The electrocardiographic changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, such as vilanterol, a component of ANORO ELLIPTA, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of ANORO ELLIPTA with non-potassium-sparing diuretics.

Anticholinergics

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

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

© 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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