×
Min. Age:
Max. Age:
Gender:
Reason:
Duration:

Anoro Ellipta

Generic Name: Umeclidinium/Vilanterol Inhalation Powder
Drug Category: Anticholinergic/LABA
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 12 months.

Approved Uses

Indicated 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.

Not indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and efficacy of ANORO ELLIPTA in patients with asthma have not been established.

ANORO ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD. ANORO ELLIPTA has not been studied in subjects with acutely deteriorating COPD. The initiation of ANORO ELLIPTA in this setting is not appropriate.

ANORO ELLIPTA should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. ANORO ELLIPTA has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.

Do not use ANORO ELLIPTA more than 1 time every 24 hours.

When beginning treatment with ANORO ELLIPTA, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs and to use them only for symptomatic relief of acute respiratory symptoms. When prescribing ANORO ELLIPTA, the healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient on how it should be used.

Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone. 

Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

ANORO ELLIPTA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

ANORO ELLIPTA, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines.

As with other inhaled medicines, ANORO ELLIPTA can produce paradoxical bronchospasm, which may be life threatening.

Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of ANORO ELLIPTA.

ANORO ELLIPTA should be used with caution in patients with narrow-angle glaucoma.

Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.

ANORO ELLIPTA should be used with caution in patients with urinary retention.

Patients using ANORO ELLIPTA should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.

Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur.

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.

Caution is advised in the coadministration of ANORO ELLIPTA with non–potassium-sparing diuretics.

Avoid co-administration of ANORO ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

There are no adequate and well-controlled trials of ANORO ELLIPTA or its individual components, umeclidinium and vilanterol, in pregnant women.

Since there are no data from well-controlled human studies on the use of ANORO ELLIPTA by nursing mothers, based on the data for the individual components, a decision should be made whether to discontinue nursing or to discontinue ANORO ELLIPTA, taking into account the importance of ANORO ELLIPTA to the mother.

GoToSource

Off-label Uses

• Use in patients under the age of 18. GoToSource

Adverse Events

Nasopharyngitis and upper respiratory tract infection. GoToSource 

Cardiac arrhythmias (atrial fibrillation and tachycardia) and urinary tract infection. GoToSource 

Hyperglycemia (high blood sugar). GoToSource

Paradoxical bronchospasm, anaphylactic reactions (potentially life-threatening allergic reaction), hypokalemia (low blood potassium level), gastroesophageal reflux disease, myocardial infarction, pruritus (severe itching), rash and conjunctivitis. GoToSource 

Increased risk of asthma-related death, increased pulse rate and blood pressure, aggravation of preexisting diabetes mellitus and ketoacidosis (body produces high levels of (ketones) blood acids). GoToSource

Blurred vision and urinary retention. GoToSource

Litigation

Lawsuits filed for heart attacks.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

 iOSAndroidAppOrchard - EPIC EHR

Site Last Updated March 29, 2024