What is Breo Ellipta?

Breo Ellipta (fluticasone furoate/vilanterol)is a dry powder oral inhalation combination of vilanterol trifenatate, a long-acting beta-adrenergic agonist (LABA) and fluticasone furoate, an inhaled corticosteroid (ICS). It is considered a once-daily, long-term, maintenance treatment to help adults reduce the effects of lung diseases, such as chronic obstructive pulmonary disease (COPD) and asthma symptoms. This would include other lung diseases such as chronic bronchitis and emphysema. To ensure lung function, Breo Ellipta should not be used for rescue measures, such as asthma attacks. It is manufactured by GlaxoSmithKline LLC.

How does Breo Ellipta work?

Breo Ellipta’s two active ingredients work in two separate ways to fight future flare-ups of exacerbations of your lung disease. Fluticasone is a steroid that prevents the release of substances in the body that causes inflammation. Vilanterol is a bronchodilator that works by relaxing muscles in the airways to improve breathing.

What doses of Breo Ellipta are available?

The dosage of Breo Ellipta depends on the lung disease it is treating. For the maintenance treatment of COPD, one inhalation of the Breo Ellipta 100/25 dosage is usually prescribed for daily use. For asthma, either the 100/25 or the Breo Ellipta 200/25 is prescribed depending on you and your doctor. No matter the strength, the inhaler will have two foil blisters. One strip contains 25 mcg of vilanterol and the other contains 100 or 200 mcg of fluticasone furoate.

How do you use Breo Ellipta?

Before using Breo Ellipta, you should follow all directions given by your healthcare provider as well as the directions on your prescribing information and medication guide. Since Breo Ellipta is a long-acting treatment of asthma and COPD, it should not be used as a treatment for potentially life-threatening episodes of asthma or COPD.

Breo Ellipta is only available as an oral inhalation powder that is preloaded with blister packs containing the medication. Use the medicine at the same time every day and no more than once in 24 hours. Your doctor may change your dosage due to stress, recent asthma attacks, surgery, or illness. Do not change your dosage without your doctor’s advice.

Do not use a second inhaled bronchodilator, such as Servent or Anoro Ellipta. There could be a chance of an overdose.

Always rinse your mouth after using the inhaler device to avoid a fungal infection in your mouth, known as thrush. If you miss a dose, take it as long as it is not closer to the time of your next scheduled dose. Do not take extra medicine to make up for the mixed dose.

What are the side effects of Breo Ellipta?

The most common side effects of Breo Ellipta in clinical trials compared to placebo include:

General possible side effects:
- New or worsening infections (including existing tuberculosis, bacterial, fungal, parasitic, or viral infections).
  - If you’re susceptible, serious or even fatal events of measles or chickenpox can occur.
- Eye problems, including glaucoma and cataracts.

If you have COPD, possible adverse reactions include:
- Nasopharyngitis
- Oral candidiasis
- Headache
- Shortness of breath
- Back pain
- Sinusitis
- Oropharyngeal pain
- Pneumonia
- Bronchitis
- Sore throat
If you have asthma, possible adverse reactions include:
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Shortness of breath
- Oral candidiasis
- Influenza
- Sinusitis
- Sore throat

Rarely, Breo Ellipta may cause some serious side effects, including:

Paradoxical bronchospasm.
- If this happens, stop Breo Ellipta and seek alternative therapy.

Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Breo Ellipta. You can report your adverse effects to the Food and drug administration at 1-800-FDA-1088 or www.fda.gov/medwatch.

Breo Ellipta drug interactions

When Breo Ellipta is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Some drug interactions with Breo Ellipta include:

Strong cytochrome P450 3A4 inhibitors (ketoconazole, ritonavir).
- This may cause systemic corticosteroid and cardiovascular effects.
Tricyclic antidepressants and monoamine oxidase inhibitors.
- This may potentiate the effect of vilanterol on your vascular system.
Beta-blockers.
- This may block the effects of beta-2 agonists and produce intense bronchospasm.
Diuretics.
- Non–potassium-sparing diuretics may begin to worsen with concomitant beta-agonists.

Boxed warnings

When using long-acting beta adrenergic agonists (LABA), there is an increase in the risk of asthma-related death and hospitalization, including in adolescent and pediatric patients. Breo Ellipta should only be for patients that cannot control their asthma with another long-term asthma control medication, such as an ICS.

When asthma is in control and maintained, assess the patient at regular intervals and introduce step-down therapy. If it is possible without the loss of asthma control, discontinue Breo Ellipta.

Try not to use Breo Ellipta if low or medium-dose ICS is enough. ICS and Breo Ellipta can be used together without an increased risk of hospitalization.

Breo Ellipta precautions

You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

Deteriorating COPD or asthma.
An allergy to milk proteins.
A weak immune system.
Cataracts or glaucoma.
Heart disease or high blood pressure.
A thyroid disorder.
A pregnancy, think you may be pregnant or are breastfeeding.
Liver disease.
Diabetes.
Had a seizure.
Osteoporosis.
Had any type of infection (fungal, bacterial, parasitic, or viral).

An overdose should be treated immediately by a healthcare professional and may include the following symptoms:

Fast heart rate.
Chest pain.
Shaky or short of breath.

An allergic reaction may occur while taking Breo Ellipta. Call your doctor immediately if you experience any of the following:

Fast or pounding heartbeats, chest pain, pounding in your neck or ears.
Choking, wheezing, or other breathing problems after using Breo Ellipta.
Chills, fever, cough with green or yellow mucus.
White patches or sores in your mouth and throat, pain when swallowing.
High blood sugar; signs include:
- Increased urination, increased thirst, dry mouth, or fruity breath odor.
Eye pain: blurred vision, seeing halos around lights, or tunnel vision.
Signs of a hormonal disorder, including the possible symptoms:
- Feeling light-headed, muscle weakness, worsening tiredness, vomiting, or nausea.
Low potassium, level including the possible symptoms:
- Fluttering in your chest, leg cramps, constipation, increased thirst or urination, irregular heartbeats, muscle weakness or limp feeling, numbness or tingling.

Is there a generic available for Breo Ellipta?

Yes, Fluticasone-Vilanterol is the generic for Breo Ellipta.

How do you store Breo Ellipta?

Store Breo Ellipta Inhaler at room temperature, away from moisture and heat. Keep the inhaler in the sealed foil tray until you are ready to use it. Once you have opened the tray, use the inhaler within six weeks.