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.
Prescription Required.
Product of Canada.
Shipped from Canada.
| Prescription Required. | Product of Canada. | Shipped from Canada. |
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.
Side Effects
Common side effects of BREO ELLIPTA include:
- Thrush in the mouth and throat (Candida albicans)
- Sinusitis
- Headaches
- Back pain
- Fever
- Chest infection
- Changes in voice
- Changes in taste
- Difficulty sleeping
Less common side effects include:
- Pneumonia
- Bronchitis
- Suppression of the immune system
- Reduction in bone density
- Inhibition of growth in children
- Glaucoma and cataracts
- Systemic eosinophilia
- Churg-Strauss syndrome
- Anaphylaxis
Drug Interactions
Certain drugs may interact with BREO ELLIPTA. These include:
- antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- antiretrovirals (e.g., ritonavir, atazanavir, indinavir)
- antibiotics (e.g., clarithromycin, telithromycin)
- antidepressants (e.g., nefazodone)
- Other long-acting beta2-agonists
- Loop diuretics
- Beta-blockers
- Monoamine oxidase inhibitors
- Tricyclic antidepressants
Frequently Asked Questions
People who take BERO ELLIPTA have an increased risk of death from asthma-related problems. This is because of vilanterol, a long-acting beta2-adrenergic agonist. Therefore, it is essential to contact your healthcare provider if you experience worsening breathing while using BREO ELLIPTA. You should seek urgent medical care if you have a rapid worsening of your breathing, and your rescue inhaler does not help to relieve these symptoms.
BREO ELLIPTA is manufactured as a dry powder. It is presented in an inhaler that contains two blister strips filled with the powdered formulation. One of the strips contains fluticasone furoate 100 mcg or 200 mcg. The other strip contains vilanterol 25 mcg.
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.
The BREO ELLIPTA comes in a sealed foil tray. To open the tray, peel back the lid. Each inhaler can dispense 30 doses. When you open the inhaler cover, you will hear a clicking sound, and the dose counter will decrease by one. Opening the cover primes the inhaler for delivery. Do not close the cover without inhaling the medication or you will lose the prepared dose. You cannot take a double dose because the prepared dose will become unavailable if you close the cover.
To inhale the dose, slide the cover down so that you can see the mouthpiece. You will hear a click, and the counter will go down by one number. You do not need to shake this inhaler. Hold the inhaler away from your mouth and breathe out completely. Make sure that you do not breathe into the mouthpiece. Now place the mouthpiece between your lips and take a long deep breath in through your mouth. Make sure that you do not breathe in through your nose. Also, ensure that your hands do not block the air vent on the inhaler. Hold your breath for three to four seconds after you have inhaled. When breathing in the powder, you may not taste or feel it. This does not mean that you have not received a dose. Once you have taken the required dose, close the inhaler by sliding the cover back into position.
It is important to rinse your mouth out once you have inhaled your dose. This is to prevent you from developing thrush in your mouth and throat. Make sure that you do not swallow the water.
BREO ELLIPTA is contraindicated in patients with a hypersensitivity to milk proteins, fluticasone furoate, or vilanterol.
BREO ELLIPTA is also contraindicated in patients with status asthmaticus or acute exacerbations of chronic obstructive pulmonary disease who may be requiring intensive management measures.
If you miss a dose of BREO ELLIPTA, try to take it as soon as possible, then continue with the usual medication schedule. However, if you are due to take your next dose, skip the dose you missed and continue with your regular medication schedule. Under no circumstances should you take a double dose of the medication to make up for the missed dose. If you are unsure about what to do, contact your doctor or local pharmacist to obtain advice.
BREO ELLIPTA is an inhaled corticosteroid. The most common side effect is related to the steroid’s immunosuppressive effect, which can cause thrush in the mouth and throat. This is generally easily treated by your doctor using antifungal therapy. Other side effects include:
- Sinusitis
- Headaches
- Back pain
- Fever
- Chest infection
- Changes in voice
- Changes in taste
- Difficulty sleeping
- Thrush in the mouth and throat (Candida albicans)
Less common side effects include:
- Pneumonia
- Bronchitis
- Suppression of the immune system
- Reduction in bone density
- Inhibition of growth in children
- Glaucoma and cataracts
- Systemic eosinophilia
- Churg-Strauss syndrome
- Anaphylaxis
Some side effects can be severe and require medical attention. Contact your doctor immediately if you notice any of the following:
- worsening of your asthma
- difficulty breathing
- shortness of breath
- tight chest
- changes in your vision
- swelling of your face with a skin rash
- acute confusion or aggression
- development of a temperature or other signs of an infection
If you experience severe side effects, immediately contact your doctor, or go to the nearest emergency health care facility.
BREO ELLIPTA should be stored away from children. It should be stored in a dry place at room temperature, away from heat and sunlight. It should be stored unopened in its foil pouch and only opened when ready for use.