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Breo Ellipta is the brand name for fluticasone furoate and vilanterol and is available as an inhalation powder.

Breo Ellipta is available as an inhalation powder that contains one of the following:

• 50 mcg fluticasone furoate and 25 mcg vilanterol (50/25 mcg) per actuation
• 100 mcg fluticasone furoate and 25 mcg vilanterol (100/25 mcg) per actuation
• 200 mcg fluticasone furoate and 25 mcg vilanterol (200/25 mcg) per actuation

Breo Ellipta is an ICS / LABA combo and is used for the following:

• Maintenance treatment of asthma
• Maintenance treatment of COPD

Breo Ellipta is a combination of two medications that work together to make it easier to breathe in people with asthma and COPD symptoms. Fluticasone is an inhaled corticosteroid. It’s thought to lower inflammation and swelling in the lungs. Vilanterol is a long-acting beta agonist. It relaxes the muscles in your lungs to open up your airways.

Breo Ellipta is typically dosed as follows:

Asthma:

• Ages 18 years and older: Your prescriber will determine your dose based on how severe your asthma is and what other medications you’ve taken. The typical dose is 1 inhalation of Breo Ellipta 100 mcg/25 mcg (fluticasone / vilanterol) or 200 mcg/25 mcg (fluticasone / vilanterol) by mouth once daily
• Ages 12 to under 18 years (brand Breo Ellipta only): The typical dose is 1 inhalation of Breo Ellipta 100 mcg/25 mcg (fluticasone / vilanterol) by mouth once daily
• Ages 5 to under 12 years (brand Breo Ellipta only): The typical dose is 1 inhalation of Breo Ellipta 50 mcg/25 mcg (fluticasone / vilanterol) by mouth once daily

COPD:

• The typical dose is 1 inhalation of Breo Ellipta 100 mcg/25 mcg (fluticasone / vilanterol) by mouth once daily

Breo Ellipta is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

• Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures
• Severe hypersensitivity to milk proteins or any ingredients

Common side effects of Breo Ellipta:

• Common cold
• Upper respiratory tract infection
• Headache
• Oral thrush (fungal infection in mouth)

Serious side effects are rare with Breo Ellipta. Contact your healthcare provider immediately if you experience any of the following.

• Serious allergic reaction: hives, swelling of your face, lips, or tongue, difficulty breathing
• Sudden narrowing of your airways: difficulty breathing, wheezing, chest pain or tightness, cough
• Heart problems: dizziness, fatigue, tremor, nausea, rapid heartbeat, weakness, or difficulty sleeping

The following medications may interact with Breo Ellipta:

• Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects
• Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution
• May potentiate effect of vilanterol on cardiovascular system
• Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm
• Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists

GlaxoSmithKline

It is not known if Breo Ellipta may harm your unborn baby. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• Fluticasone Furoate/Vilanterol