Breo Ellipta (Fluticasone and Vilanterol) - Inhalation

What Is Breo Ellipta?

Breo Ellipta is a prescription inhalation powder containing a combination of two drugs, fluticasone furoate and vilanterol trifenatate. It is used in adults with asthma and chronic obstructive pulmonary disease (COPD) to improve symptoms and prevent bronchospasm and asthma attacks.

Fluticasone furoate is a corticosteroid that prevents the release of substances in the body that cause inflammation. It reduces the swelling of the airways in the lungs to make breathing easier. 

Vilanterol trifenatate is a long-acting beta-agonist (LABA) that works by relaxing the muscles around the airways to improve breathing.

The powder comes with an inhalation device to use once daily or as prescribed by a medical professional.

What Is Breo Ellipta Used For?

The Food and Drug Administration (FDA) approved Breo Ellipta (fluticasone and vilanterol) to control asthma symptoms and COPD (a group of conditions that affect the lungs and airways), including chronic bronchitis and emphysema.

The symptoms of asthma and COPD include:

• Wheezing
• Shortness of breath
• Coughing
• Chest tightness

When used alone, LABAs (like vilanterol) may sometimes increase the risk of serious asthma-related breathing problems. However, the combination of inhaled corticosteroids and LABAs, such as Breo Ellipta, does not increase the risk of severe breathing problems occurring with asthma. 

Because it only needs to be used once a day, this medication can also help improve treatment adherence.

How to Take Breo Ellipta

Read the guidelines on the label before using this medication. Ask your doctor or pharmacist if you do not understand anything. Before using the inhaler for the first time, ask your healthcare provider to show you how to use it.

Breo Ellipta is available as a powder to inhale by mouth once a day or as directed by your healthcare provider. It comes with a particular inhaler device preloaded with blister packs containing measured doses of the medicine. Each time you use the inhaler, the device opens and loads a blister of Breo Ellipta. Follow the directions provided with the inhaler device.

Do not use more than one inhalation daily. If you open and close the inhaler cover without inhaling the medicine, you have lost the dose. If this happens, load a new dose and inhale it.

Rinse your mouth with water or gargle after each dose to prevent dry mouth, hoarseness, and oral yeast infections (thrush). Do not swallow the rinse water.

You should use this medication regularly to get the most benefit from it. Take it at the same time each day to avoid missing a dose. Do not use Breo Ellipta during a sudden attack of asthma or COPD. A short-acting inhaler is more effective during these attacks. Ask your healthcare provider to prescribe the suitable one for you.

Breo Ellipta controls the symptoms of asthma and COPD but does not cure them. Continue to use it even if you feel well. Do not stop using without talking to a medical professional, as your symptoms may return.

Storage

Keep the medicine in the foil tray it came in, tightly closed and out of reach of children. Store at room temperature, away from sunlight, excess heat, and moisture. Do not store it in the bathroom. Dispose of the inhaler six weeks after removal from the foil overwrap or after all blisters have been used and the dose indicator reads zero.

Keep all medicines out of sight and reach of children.

Properly discard unneeded or expired medications. Do not flush the medicines down the toilet or throw them in the waste bin. Instead, the best way is to return the medication through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department about take-back programs in your community.

What Are the Side Effects of Breo Ellipta?

This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Like other medications, Breo Ellipta can cause side effects. Let your healthcare provider know about any side effects you have while using this medication.

Common Side Effects

Some of the most common side effects of Breo Ellipta are:

• Headache
• Nervousness
• Shaking of body parts that you cannot control
• Joint pain
• Back pain
• Runny nose or sore throat
• Cough
• Hoarse voice

Call your healthcare provider if any of the symptoms worsen or do not go away.

Severe Side Effects

Some side effects can be severe. Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Symptoms of severe allergy (hives; rash; swelling of the face, throat, or tongue)
• Pounding, fast, or irregular heartbeat
• Chest pain
• Coughing, wheezing, or breathing problems after inhaling Breo Ellipta
• White patches in the mouth or throat
• Pain when swallowing
• Fever or chills
• Cough with green or yellow mucus (change in the color of sputum)
• Blurred vision, tunnel vision, eye pain, or seeing halos around lights
• High blood sugar
• Increased thirst
• Increased urination
• Dry mouth
• Low potassium level 
• Worsening tiredness or muscle weakness
• Feeling light-headed
• Nausea
• Vomiting

Long-Term Side Effects

If used for a long time, inhaled corticosteroids can increase the risk of bone loss (osteoporosis) in adults. Talk with your healthcare provider about the risk of osteoporosis and potential treatment options. People with significant risk factors for decreased bone mineral content should be monitored by their healthcare provider.

Lifestyle changes such as increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals can help. Consult your healthcare provider for specific advice and whether you may need to take calcium and vitamin D supplements.

Dosage: How Much Breo Ellipta Should I Use?

Missed Dose

If you miss a regular inhalation of Breo Ellipta, take it as soon as you remember. Skip if it is almost time for the next inhalation. Do not take two inhalations in 24 hours to make up for the missed dose.

Overdose: What Happens If I Take Too Much Breo Ellipta?

Do not use Breo Ellipta more often than prescribed or at higher doses than recommended, as an overdose can occur. You may also overdose if you take Breo Ellipta with other medications containing LABA (e.g., salmeterol, formoterol fumarate).

Overdosing on fluticasone furoate itself is unlikely, but overdosing on vilanterol is possible.

Signs and symptoms of a vilanterol overdose include:

• Seizures
• Angina
• Hypertension (high blood pressure) or hypotension (low blood pressure)
• Tachycardia (rapid heartbeat)
• Arrhythmias
• Nervousness
• Headache
• Tremor
• Muscle cramps
• Dry mouth
• Palpitation
• Nausea
• Dizziness
• Fatigue
• Malaise
• Insomnia
• Hyperglycemia
• Hypokalemia
• Metabolic acidosis

An overdose of vilanterol can also cause cardiac arrest and even death.

Precautions

What Are Reasons I Shouldn’t Take Breo Ellipta?

Breo Ellipta is typically well tolerated, but it may not be safe to use in certain circumstances, such as:

• An allergy to fluticasone or vilanterol, or any other allergies to the ingredients of this medication
• Lactose intolerance or allergy to milk products: Breo Ellipta may contain milk proteins, which can cause allergic reactions or other problems.
• Pregnancy: There is not enough resource data to prove whether Breo Ellipta will harm an unborn baby or not. Tell your healthcare provider if you are pregnant.
• Breastfeeding: It is unknown if Breo Ellipta is safe to use while breastfeeding. Ask your provider about any risk factors.
• Age: This medication is not approved for use by anyone younger than 18 years old.

To make sure that this medicine is safe for you, tell your healthcare provider if you have:

• Glaucoma, increased pressure in the eye, cataracts, or change in vision
• Weak immune system
• Heart disease
• QT prolongation 
• High blood pressure
• Thyroid disorder
• Liver disease
• Seizure
• Diabetes
• Infection (bacterial, viral, or fungal)
• Osteoporosis
• If you have shifted from a corticosteroid such as prednisone to an inhaler

What Other Medications Interact With Breo Ellipta?

Consult a healthcare professional if you use another LABA, such as formoterol or salmeterol.

Several medications can interact with fluticasone and vilanterol inhalation, including:

• Certain antifungals such as itraconazol, ketoconazole, and voriconazole
• Beta-blockers such as atenolol, labetalol, metoprolol, nadolol, and propranolol
• Clarithromycin/telithromycin
• Conivaptan
• Diuretics 
• HIV protease inhibitors such as indinavir, lopinavir, nelfinavir, ritonavir, and saquinavir 
• Troleandomycin
• Antidepressants such as amitriptyline, amoxapine, clomipramine desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine
• Monoamine oxidase inhibitors, including isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine 

Tell your healthcare provider what other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking. Your provider may need to change the dose of medicines or monitor the side effects carefully.

What Medications Are Similar?

Some drugs belong to the same class of medicines as Breo Ellipta and can treat the same conditions. Some may be better suited than others. If looking for an alternative to Breo, talk with your prescriber.

Some other combination medicines in this drug class include:

• Advair Diskus (fluticasone and salmeterol)
• Symbicort (budesonide and formoterol)
• Anoro Ellipta (umeclidinium and vilanterol)

Breo Ellipta is effective at preventing COPD exacerbations. Compared to others of the same class, Breo Ellipta has a long half-life, which allows patients to only have to use it once a day.

How Can I Stay Healthy While Taking Breo Ellipta?

Breo Ellipta is an effective therapy used in patients to control the symptoms of asthma and COPD. It has limited side effects when used at appropriate doses.

Lifestyle changes can also help to minimize any long-term issues associated with Breo Ellipta use or your underlying health condition.

These changes can include:

• Weight-bearing exercise
• Stopping smoking
• Limiting alcohol intake
• Eating well-balanced meals

If using Breo Ellipta for the long-term management of severe asthma, make sure to keep to your dosing schedule. Do not stop treatment or change the dose for a sudden attack of asthma or COPD. Let your healthcare provider know if you have any problems with your treatment or condition.