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Breo Ellipta

Generic Name: Fluticasone Furoate/Vilanterol
Drug Category: ICS/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 76 weeks.

Approved Uses

Indicated for: 

Maintenance Treatment of Chronic Obstructive Pulmonary Disease:

• The long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BREO ELLIPTA 100/25 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA 100/25 once daily is the only strength indicated for the treatment of COPD.

Treatment of Asthma:

• The once-daily treatment of asthma in patients aged 18 years and older. BREO ELLIPTA should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta2-adrenergic agonist (LABA).

BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.

The use of BREO ELLIPTA is contraindicated in the following conditions:

  • For the primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required
  • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients

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

Patients using BREO ELLIPTA should not use additional LABA for any reason.

Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase the risk of asthma-related death. Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death.

Do not use BREO ELLIPTA for patients whose asthma is adequately controlled on low-or medium-dose inhaled corticosteroids.

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

BREO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using BREO ELLIPTA should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.

BREO 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.

An increase in the incidence of pneumonia has been observed in subjects with COPD receiving BREO ELLIPTA 100/25 in clinical trials. There was also an increased incidence of pneumonias resulting in hospitalization. In some incidences these pneumonia events were fatal. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in subjects treated with BREO ELLIPTA.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects.

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids.

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with COPD or asthma following the long-term administration of ICS.

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

There have been reports of increases in blood glucose levels with BREO ELLIPTA. This should be considered in patients with a history of, or with risk factors for, diabetes mellitus.

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

Vilanterol, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, BREO ELLIPTA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiographic changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression, although the clinical significance of these findings is unknown. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Therefore, BREO ELLIPTA, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents.

Caution should be exercised when considering the co-administration of BREO ELLIPTA with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and increased cardiovascular adverse effects may occur.

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-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, a component of BREO ELLIPTA, but may also produce severe bronchospasm in patients with COPD or asthma. Therefore, patients with COPD or asthma 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.

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, especially when the recommended dose of the beta-agonist is exceeded.

There are insufficient data on the use of BREO ELLIPTA, fluticasone furoate, or vilanterol in pregnant women. Animal studies: fetal skeletal variations.

There is no information available on the presence of fluticasone furoate or vilanterol in human milk, the effects on the breastfed child, or the effects on milk production. Low concentrations of other inhaled corticosteroids have been detected in human milk.

GoToSource

Off-label Uses

• Use in patients under the age of 18. GoToSource

• Dosage greater than 1 inhalation per day for COPD. GoToSource 

• Acute bronchospasm, primary treatment of status asthmaticus or acute episodes of COPD. GoToSource

Adverse Events

Increase risk of asthma-related death, increased risk of pneumonia, paradoxical bronchospasm, hyperadrenocorticism (excess adrenocortical hormones), hypersensitivity reactions, increased blood pressure, supraventricular tachycardia (rapid heart rate), decreased bone mineral density, glaucoma, increased intraocular pressure and cataracts. GoToSource

Nasopharyngitis (inflammation of throat and nasal passages), respiratory tract infections, oral candidiasis (thrush), dysphonia (difficulty speaking), osteoporosis and bone fractures. GoToSource

Gastrointestinal bleeding, ulcer and esophagitis. GoToSource

Adrenal suppression. GoToSource

Litigation

Lawsuits filed for death, serious infections, cancer and gastrointestinal bleeding.

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Site Last Updated March 29, 2024