
What is the Breo Ellipta?
BREO ELLIPTA is a prescription corticosteroid and long-acting beta2-adrenergic agonist inhaled into the lungs for the treatment of asthma. It is manufactured as BREO ELLIPTA 100/25, a combination of fluticasone furoate 100 mcg and vilanterol 25 mcg, and BREO ELLIPTA 200/25, a combination of fluticasone furoate 200 mcg and vilanterol 25 mcg.
How Does Breo Ellipta Work?
BREO ELLIPTA is a combination dry powder corticosteroid and long-acting beta2-adrenergic agonist that is breathed into the lungs using an inhaler. The steroid, fluticasone furoate, settles into the lung tissue and suppresses the chronic inflammation caused by asthma. The long-acting beta2-adrenergic agonist, vilanterol, stimulates the beta2 receptors in the lung, causing prolonged dilatation of smooth muscle in the lung bronchi.
What Are The Indications For Breo Ellipta?
BREO ELLIPTA is indicated for the long-term treatment of persistent asthma and chronic obstructive pulmonary disease. It works to prevent and control shortness of breath and wheezing caused by asthma and to regain control of chronic obstructive pulmonary disease. It must be used regularly (for at least two weeks) before any effect is seen. Its slow onset of action means that it should not be used to treat acute asthma or relieve acute bronchospasm.
What Is The Dose Of Breo Ellipta?
The dose of BREO ELLIPTA for the treatment of chronic obstructive pulmonary disease is one inhalation of the fluticasone furoate 100 mcg/vilanterol 25 mcg combination, taken once a day.
The dose of BREO ELLIPTA for the treatment of chronic asthma is one inhalation of the fluticasone furoate 200 mcg/vilanterol 25 mcg combination, taken once a day.
Warnings & Precautions
Increased risk of asthma-related deaths
BREO ELLIPTA contains vilanterol, a long-acting beta2-agonist. Studies have shown that these agonists increase the risk of asthma-related deaths. However, it is unclear whether combining long-acting beta2-agonists with steroid formulations mitigates this risk. In addition, data suggest that the use of long-acting beta2-agonists in pediatrics and adolescents increases the risk of hospitalization.
Appropriate patient selection
BRIO ELLIPTA should only be prescribed for patients who have not been adequately controlled with long-term use of inhaled corticosteroids, or who have such severe disease that a combination of steroid and beta2-adrenergic agonist therapy is required. Once the patient has been adequately controlled with BRIO ELLIPTA, attempts should be made to step down therapy to inhaled steroids only. Do not use BRIO ELLIPTA to manage patients with adequate asthma control who are taking low-dose or medium-dose inhaled corticosteroids.
Oral candida infection risk
BREO ELLIPTA contains a steroid that may cause the development of thrush (Candida Albicans) in the mouth and throat. Patients should rinse their mouths with water after inhaling their doses to prevent this from developing. In addition, monitor patients regularly for the development of thrush.
Acute asthmatic deterioration
BREO ELLIPTA should not be used for the management of acute asthmatic deterioration. It has no intrinsic bronchodilatory effects. Therefore, using it during an acute asthmatic deterioration will not help relieve any symptoms. It should also not be used in patients having an acute exacerbation of their chronic obstructive pulmonary disease.
Immunosuppression
BREO ELLIPTA contains a corticosteroid that causes mild suppression of the immune system. This may worsen existing bacterial, fungal, or viral infections. Patients with tuberculosis, herpes simplex, measles, or chickenpox can be seriously affected.
Increased risk of pneumonia
There is an increased risk of developing pneumonia in patients using BREO ELLIPTA to manage chronic obstructive pulmonary disease. Therefore, patients should be monitored for any signs and symptoms of pneumonia.
Transferring from oral steroids to BREO ELLIPTA
BREO ELLIPTA delivers steroid directly to the lung. As a result, there is a lower steroid concentration in the rest of the body. Therefore, when transferring from oral steroids to BREO ELLIPTA there is a risk that the body will have insufficient levels of corticosteroid available, leading to a clinical picture of adrenal insufficiency.
Suppression of the adrenal system
BREO ELLIPTA results in lower levels of steroids in the rest of the body than when taking oral steroids. However, this lower dose may still be enough to suppress the body’s production of corticosteroids from the adrenal glands. This may lead to adrenal insufficiency during periods of severe stress, where additional corticosteroid is needed, or when BREO ELLIPTA is suddenly stopped.
Risk of worsening airway obstruction
Some patients may experience a paradoxical worsening of their bronchospasm when starting BREO ELLIPTA. Should this happen, treatment with BRIO ELLIPTA should be stopped, and an alternative therapy started.
Bone mineral density reductions
Patients taking BREO ELLIPTA are at risk of reducing their bone density due to the long-term effect of the inhaled steroid. This may increase the risk of developing bone fractures.
Inhibition of growth in children
Children who take BREO ELLIPTA are at risk of having a lower growth rate. The lowest dose that can control the patient’s asthma should be used. Children taking BREO ELLIPTA should have their growth monitored.
Glaucoma and Cataracts
The long-term use of inhaled steroids can cause an increase in eye pressure (glaucoma). It also increases the long-term risk of developing cataracts.
Eosinophilia and Churg-Strauss Syndrome
Rarely long-term inhaled corticosteroids can cause an increase of eosinophils in the body that presents with clinical features consistent with a Churg-Strauss Syndrome vasculitis
Cardiovascular disease risk
Vilanterol may stimulate beta-adrenergic receptors in the heart and cause elevations in heart rate. In patients with heart disease, this may exacerbate their symptoms.
Co-morbid conditions
BREO ELLIPTA should be used with care in patients with a history of seizures, diabetes mellitus, ketoacidosis, or thyrotoxicosis. Patients should also be monitored for the development of hyperglycemia and hypokalemia.
Special Populations
Hepatic impairment
The blood levels of fluticasone furoate may increase in patients with moderate or severe hepatic impairment. Patients should be monitored for systemic side effects of corticosteroids.
Renal impairment
There are no significant increases in the blood levels of fluticasone furoate or vilanterol in patients with severe renal dysfunction. No dose adjustments are therefore required in this population.
Children
BREO ELLIPTA is tested in persons under the age of 18 years. As a result, its use is not recommended in this age group.
Pregnancy
BREO ELLIPTA has not been extensively studied in pregnant women. However, some studies have shown that its use does not increase the risk of birth abnormalities. Pregnant women with asthma taking BREO ELLIPTA should be monitored closely.
Breastfeeding
The safety of BREO ELLIPTA has not been tested in breastfeeding mothers. Its active ingredients (fluticasone furoate and vilanterol) are found in breastmilk. The risk to the infant should be weighed up against the benefit for the mother. This should be discussed with a doctor.
Use in the elderly
Data suggest that no dosage adjustments are required when prescribing BRIO ELLIPTA for elderly patients.
Contraindications
BREO ELLIPTA is contraindicated in patients with a hypersensitivity to milk proteins, fluticasone furoate, or vilanterol.
BREO ELLIPTA is contraindicated in patients with status asthmaticus or acute exacerbations of chronic obstructive pulmonary disease who may be requiring intensive management measures.
The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects that are not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.
Drug Interactions
Frequently Asked Questions
Disclaimer
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