Breo Ellipta dosage, forms, and strengths

The Breo Ellipta inhaler serves as a convenient medication for controlling asthma and chronic obstructive pulmonary disease (COPD), both emphysema and chronic bronchitis forms. The convenience comes from its once-a-day dosing and being a combination inhaler, consisting of a long-acting bronchodilator and an inhaled corticosteroid (ICS). Vilanterol performs the bronchodilator duties, providing a 24-hour sustained effect opening bronchial airways. Fluticasone, the inhaled corticosteroid, reduces swelling and inflammation in the lining of airways. Breo Ellipta (fluticasone furoate/vilanterol) is a brand-name drug, available as a 100 mcg/25 mcg or 200 mcg/25 mcg one-time daily inhaler.

Breo Ellipta forms and strengths

• Dry powder inhaler: 100 mcg/25 mcg, 200 mcg/25 mcg 

Breo Ellipta dosage for adults

Both dosage forms of Breo Ellipta are available for adults with asthma, but only the lower dose version is appropriate for COPD. For those with asthma, the starting dose can be individualized based on one’s severity and prior medication. In both dosing versions and in treatment of all cases of asthma and COPD, the vilanterol daily dosage is limited to 25 mcg. If more than 200 mcg of daily inhaled fluticasone furoate is desired, then a separate, additional fluticasone furoate inhaler is needed.

All users must recognize that the Food and Drug Administration (FDA) indication for both breathing problems is limited to maintenance therapy with Breo Ellipta. Breo Ellipta is intended as a controller medication for the diseases and not as a rescue medication for life-threatening acute bronchospasm.

Breo Ellipta dosage for asthma

Controlling asthma means not having:

• Asthma limit one’s functioning

• To use rescue inhalers, such as albuterol or other short-acting beta-2 agonist rescue inhalers, often

• Exacerbations (worsening) of the condition. 

Preventing frequent rescue inhaler use and exacerbation occurrences may be accomplished with ICS alone. Steroid-induced reductions in bronchial inflammation and swelling can be enough to reduce symptoms. Other times, a combination of inhaled steroid and long-acting beta agonist (LABA) is needed. Beta agonists stimulate airway beta receptors, which results in relaxation of bronchial smooth muscle. With adequate asthma maintenance therapy, the hope is that one experiences less asthma symptoms and no limitations once the disease is controlled.

In the treatment of asthma, LABAs should only be used alongside inhaled steroids. LABA use without ICS for asthma has been associated with an increased risk of asthma-related death. Breo Ellipta packages both LABA and ICS components together with a standard long-acting beta agonist vilanterol dose and two dose options for the steroid fluticasone furoate. The approach to asthma maintenance therapy with Breo Ellipta can take a step-down sequence, in which the higher dose is used initially with a plan to reduce the dose over time, or a step-up sequence, in which the lower dose is started and increased only if adequate control is not achieved. 

Breo Ellipta dosage for COPD

The bronchodilator and anti-inflammatory effects of Breo Ellipta can be put to good use in COPD as well. Contrary to asthma maintenance, controlling COPD can be accomplished with long-acting bronchodilators alone, either beta agonists or muscarinic antagonists. Adding ICS is an option if adequate control is not realized by bronchodilators alone. The combination of fluticasone furoate and vilanterol has been shown to reduce COPD exacerbation frequency and improve markers of lung function in the disease.

Breo Ellipta dosage for children

There are no FDA-approved pediatric indications or doses for Breo Ellipta.

Breo Ellipta dosage restrictions

Breo Ellipta should not be used for treatment of acute bronchospasm, acute COPD, or asthma attack. 

The drug should also be avoided by those with a history of hypersensitivity or serious allergic reactions to it. 

Breo Ellipta is a dry powder inhaler containing lactose, so anyone with a history of severe allergy to milk proteins should avoid it too.

An extra degree of caution and monitoring is best when Breo Ellipta is used in certain settings. For example, added consideration of risks and benefits before and during use are worthwhile in:

• Moderate to severe hepatic (liver) disease

• Heart disease

• Osteoporosis (thin bone density)

• Seizures

• Glaucoma

• Cataracts

• Chickenpox or measles risk

• Diabetes

• Hyperthyroidism (overactive thyroid)

• Hypokalemia (low potassium level)

• Ocular herpes simplex infections

Immunosuppression (weak immune systems) and chronic fungal, tuberculosis, viral, or bacterial infections are also causes for concern with Breo Ellipta, based on the immune-suppressing action of fluticasone furoate.

How to take Breo Ellipta

Breo Ellipta is a dry powder inhaler. When the cover is opened, separate internal foil blisters of fluticasone furoate and vilanterol are automatically opened. After exhaling completely, the user uses the mouthpiece and takes a long, slow, and deep breath to inhale the inhalation powder. Inhalation of Breo Ellipta is followed by breath holding for three to four seconds if possible.

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away this medicine six weeks after it was opened or when the counter reads zero.

• Use Breo Ellipta as directed. Your dose may need to be changed several times to find what works best for you. Use this medicine at the same time every day exactly as directed. Never use it more often than your doctor told you to.

• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

• This medicine is a powder that is used with its own inhaler device. Keep the medicine in the foil tray until you are ready to use the inhaler.

• Each time you open the cover of the inhaler and hear a click, the inhaler is ready to use. Do not close the cover again until you have taken your dose. You will lose the dose if you open and close the cover without inhaling the medicine.

• When you take a dose, inhale through your mouth. Do not breathe in through your nose.

• After inhaling the medication, hold your breath for as long as you can, up to three to four seconds, then breathe out slowly.

• You can clean the mouthpiece, if needed, using a dry tissue.

• The left half of the counter on the inhaler will turn red when there are less than 10 doses left. Refill your prescription as soon as possible. Throw the inhaler when it reaches zero, or if it has been six weeks since you opened the foil tray.

• When you have finished taking the medication dose, rinse your mouth out with water. Do not swallow the water after rinsing.

• If you experience more shortness of breath after Breo Ellipta doses, you may be experiencing an adverse effect called paradoxical bronchospasm. You should speak to your healthcare provider immediately.

RELATED: Can you use an expired inhaler?

Breo Ellipta dosage FAQs

How long does it take Breo Ellipta to work?

Understanding the onset of action of Breo Ellipta must take into account the two different drug components that it contains. Vilanterol produces bronchodilation within minutes. Conversely, fluticasone furoate slowly decreases bronchial inflammation and immune response, reaching half of its maximal effects in about one to two weeks. Users may feel an immediate difference based on the bronchodilation and then continue to feel steady improvement for weeks to come.

How long does Breo Ellipta stay in your system?

The half-life of inhaled fluticasone furoate is about 24 hours, while the half-life of vilanterol is about 20 hours, meaning that it takes that long for the body to eliminate half the drug. It also means that it can take approximately five days for nearly all of the drug to be cleared from the body.

What happens if I miss a dose of Breo Ellipta?

If you remember a missed dose soon after it was due, take the dose immediately. If the next dose is almost due, wait and take Breo Ellipta at that time. You should not take more than one dose of Breo Ellipta per day.

How long can you take Breo Ellipta?

Breo Ellipta can be taken indefinitely if needed. However, safety concerns slowly escalate with long-term use of inhaled corticosteroids. Monitoring may be advised for eye problems, like glaucoma and cataracts, and for osteoporosis, thin bone mineral density. Long-term ICS could lead to hypercorticism or hypercortisolism (excess cortisol levels), with consequent suppression of the adrenal glands. Adrenal insufficiency can have serious effects, such as hypotension (low blood pressure) in the setting of illnesses. Therefore, it is best to have ongoing conversations with the treating healthcare professional about whether the benefits of Breo Ellipta continue to warrant any potential risks.

How do I stop taking Breo Ellipta?

Consulting the prescribing healthcare provider for professional medical advice is necessary before stopping Breo Ellipta. If discontinuation is agreed upon, the dose may be reduced first or may be stopped immediately. 

Monitoring for recurrent respiratory symptoms and signs of adrenal insufficiency is essential after stopping the drug. Adrenal insufficiency may cause symptoms of fatigue, nausea, or dizziness, but it can also be associated with a severe adrenal crisis involving hypotension. Stopping long-term oral, systemic corticosteroids, like prednisone, can be much more hazardous for these same reasons.

What is the maximum dosage for Breo Ellipta?

Breo Ellipta 100 mcg/25 mcg once daily is the maximum dosage for COPD, and 200 mcg/25 mcg is the maximum dosage for asthma. The limiting factor of Breo Ellipta dosing is the vilanterol. No more than 25 mcg of vilanterol can be given in one day. This beta agonist exerts its primary effects on bronchial beta receptors, but some effect on cardiac beta receptors can occur, creating a potential for tachycardia (fast heart rate) and arrhythmia (abnormal heart rhythm).

Can you overdose on Breo Ellipta?

An overdose on Breo Ellipta is possible. Symptoms of overdose include tremors, tachycardia, and chest pain. Emergent medical attention and a call to the Poison Help line at 1-800-222-1222 is advisable.

What are the side effects of Breo Ellipta?

Common side effects of Breo Ellipta include:

• Nasopharyngitis (common cold)

• Headache

• Upper respiratory infection

• Oropharyngeal candidiasis (oral thrush)

• Back pain

• Pneumonia

• Sinusitis

• Bronchitis

• Cough

• Sore throat

• Joint stiffness

• Hypertension

• Influenza

• Diarrhea

• Peripheral edema (swelling of lower legs or hands)

• Fever

• Fractures

What interacts with Breo Ellipta?

Based on its two component drugs and their potential systemic effects, Breo Ellipta can interact with numerous medications. 

Inhibitors of the enzyme CYP3A4, like the antifungal drugs ketoconazole and voriconazole, can result in too much fluticasone furoate and may need to be avoided. This can compound the risk for adrenal insufficiency. 

Medications with additive side effects are of particular concern too. For instance, medications that suppress the immune system or cause fluid retention are a risk when inhaled corticosteroids are used. 

Medications that increase heart rate or cause hypertension (high blood pressure) have additive risk when used concurrently with inhaled beta agonists. Conversely, beta blockers are used to slow down heart rate for cardiac conditions, but they can also counteract beta agonists and lead to bronchospasm. 

The following drugs should absolutely be avoided when Breo Ellipta is used:

• Desmopressin

• Isocarboxazid

• Phenelzine

• Tranylcypromine

What happens when you mix Breo Ellipta and alcohol?

While there is no absolute contraindication to using alcohol during Breo Ellipta treatment, additive systemic adverse reactions, including on heart rate, blood pressure, and sugar levels, should be considered.

Is it safe to take Breo Ellipta during pregnancy?

Unfortunately, there is not much available safety data from clinical trials of Breo Ellipta during pregnancy. Nonetheless, the risk of untreated asthma during pregnancy has been established. A detailed discussion between healthcare provider and patient of the potential benefits and risks of Breo Ellipta use in pregnancy is warranted. The conversation can carry over similarly to use during breastfeeding.

Related resources for Breo Ellipta dosage:

• Adult dosing, Epocrates

• Prescribing information, FDA

• Pediatric dosing, Epocrates

• Contraindications, Epocrates

• Adverse effects, Epocrates

• Drug interactions, Epocrates

• Pregnancy/lactation, Epocrates

• Prescribing information, GlaxoSmithKline