Breo Ellipta

The active ingredients in Breo Ellipta are fluticasone furoate and vilanterol trifenatate. This inhaler belongs to two classes of medications, including an inhaled corticosteroid (ICS) and a long-acting beta-2 agonist (LABA). Fluticasone reduces swelling in the lungs, while vilanterol is a bronchodilator that relaxes the muscles around the airways.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Breo Ellipta. However, the following is a synopsis of the general guidelines for the use of Breo Ellipta:

• Use this medication exactly as directed by your physician.
• Starting dose: Inhaled 1 puff once daily.
• Breo Ellipta typically expires in 6 weeks after it’s removed from the foil tray. Write the expiration date on the first blank line on the inhaler.
• There's a dose counter on the front of the inhaler to keep track of doses.
• There’s no need to prime or shake the inhaler before using it. Only open the cover of the inhaler if you're about to take a dose.
• Slide the cover on the inhaler until it clicks. Breathe out as long as you can, then place your lips firmly around the mouthpiece and take a long, steady, and deep breath. Then try to hold your breath for 3-4 seconds.
• Rinse your mouth with water after and spit to lower the risk of thrush.
• Never wash the inhaler with water. Clean the mouthpiece by wiping it with a dry cloth.
• If you miss a dose of Breo Ellipta, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and use it when your next dose is due.

The most common side effects of Breo Ellipta include:

• Infection in the nose or throat.
• Sore throat.
• Headache.
• Oral thrush (fungal infection).
• Back pain.
• Cough.
• High blood pressure (hypertension).
• Fever.
• Hoarseness.

Some individuals may experience serious side effects while using Breo Ellipta. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious allergic reaction - hives, itching, swelling, rash.
• Reduced adrenal function (adrenal insufficiency).
• Sudden breathing problems after using the inhaler - shortness of breath, wheezing, trouble breathing, chest pain.
• Eye problems such as glaucoma and cataracts.
• Increased blood sugar.
• Increased risk of low potassium levels (hypokalemia) - muscle pain or weakness, muscle cramps, or an irregular heartbeat.
• Weak bones.
• Slowed growth in children.

These are not all of the possible side effects of Breo Ellipta. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Breo Ellipta, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• History of immune system problems.
• Diabetes or high blood sugar.
• Eye problems - glaucoma, cataracts.
• Heart problems.
• High blood pressure.
• Osteoporosis.
• Liver problems.
• Seizures.
• Thyroid problems.

• Previous severe allergic reaction/hypersensitivity to milk proteins and any ingredients of Breo Ellipta.
• Treatment of an asthma attack or other acute episodes of COPD or asthma where intensive measures are required.

Patients usually experience an improvement in lung function within 15 minutes of inhaling Breo Ellipta. However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.

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. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Beta-blocker.
• Diuretic or “water pill”.
• Other long-acting beta-2 agonists (LABA) (salmeterol, formoterol).
• Medication for HIV or AIDS.
• Other corticosteroids.
• Monoamine oxidase inhibitor (MAOI) within the past two weeks.
• Tricyclic antidepressant.
• Medications that cause QT prolongation.
• Ketoconazole.

Breo Ellipta is available in a variety of strengths, including:

• 50 mcg/25 mcg inhalation powder (Ellipta inhaler).
• 100 mcg/25 mcg inhalation powder (Ellipta inhaler).
• 200 mcg/25 mcg inhalation powder (Ellipta inhaler).

Store this medication at room temperature in a cool and dry place and keep it out of reach of children.

GlaxoSmithKline (GSK) is the pharmaceutical company that manufactures Breo Ellipta.

There are no lower-cost generics available for the brand-name Breo Ellipta.

Do not stop or adjust your use of this medication without consulting your doctor first. Stopping this medication suddenly can increase your risk of sudden breathing problems.

It is unknown if or how Breo Ellipta could affect pregnancy or harm an unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if Breo Ellipta passes into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.