Breo Ellipta (fluticasone furoate and vilanterol trifenatate)

Combination inhalers may be prescribed for people with moderate to severe asthma. These inhalers combine a corticosteroid with a long-acting beta2 agonist (LABA). Corticosteroids reduce inflammation, making the airways less sensitive. LABAs relax the muscles in the airways to open them up, making breathing easier. Having the two medications in one inhaler is convenient.

What is Breo Ellipta?

Breo Ellipta is a combination inhaler used for the treatment of asthma in people 18 years and older whose asthma is not well controlled on an inhaled corticosteroid alone. This inhaler combines two medications: fluticasone furoate, an inhaled corticosteroid, and vilanterol, a LABA. It should not be used to relieve sudden breathing problems and does not replace a rescue inhaler.

Because of the safety risks with a LABA like the one in Breo Ellipta, only patients whose asthma is not adequately controlled on a long-term asthma medication, like an inhaled corticosteroid, or whose disease is severe should be prescribed Breo Ellipta. In addition, once asthma control is achieved and maintained, the patient will be assessed and treatment with this inhaler may be discontinued if asthma control continues.¹

What are the ingredients in Breo Ellipta?

The active ingredients are fluticasone furoate and vilanterol.

How does Breo Ellipta work?

Breo Ellipta contains two medications with two different mechanisms of action. The corticosteroid, fluticasone furoate, works as an anti-inflammatory, targeting several different components of the inflammation process. The LABA, vilanterol, relaxes the bronchial muscles (those in the airways). The two medications work together to improve breathing for 24 hours.¹

Possible side effects of Breo Ellipta

The most common side effects experienced by people taking Breo Ellipta are upper respiratory infections, oral yeast infections (candidiasis), headache, flu, colds, bronchitis, sinus infections, sore throat, hoarse throat, and cough. This inhaler may cause reduced adrenal function (the hormone secreting glands on top of the kidneys), and cause symptoms such as tiredness, lack of energy, weakness, nausea, vomiting, and low blood pressure.

Rarely, Breo Ellipta may cause serious side effects. LABAs, like vilanterol, have been associated with an increased risk of death related to asthma, as well as hospitalizations due to asthma. It may also weaken the immune system, increasing the chance of infection. People taking Breo Ellipta should avoid exposure to chickenpox and measles or talk to their doctor right away if they get exposed. This medicine may worsen existing infections, including tuberculosis (TB), fungal, bacterial, viral, or parasitic infections.

People taking Breo Ellipta who experience sudden breathing problems immediately after inhaling the medicine or experience serious allergic reactions, including rash, hives, swelling of the face, mouth, or tongue, should contact their doctor or seek emergency medical care right away. Breo Ellipta may also cause increased blood pressure, a fast or irregular heartbeat, chest pain, nervousness, osteoporosis, eye problems like glaucoma and cataracts, and changes in laboratory blood values, such as sugar and potassium.^1,2

These are not all the possible side effects of Breo Ellipta. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Breo Ellipta.

Things to know

• It should not be used as a rescue inhaler.
• People who are allergic to milk proteins or any of the ingredients in Breo Ellipta should not take this medicine.
• People taking this medicine should not take other medicines containing a LABA for any reason.
• Children and adolescents who use Breo Ellipta may be at an increased risk of being hospitalized for asthma problems.
• Do not take this medicine more often than it is prescribed (usually once daily).^1,2
• The safety and efficacy of Breo Ellipta in children and adolescents is not known at this time. It should not be used by these individuals.

Pregnancy and breastfeeding

The effects of Breo Ellipta on pregnant women and developing babies are not known. In some animal studies, other similar medications have been teratogenic (harmful to developing babies). Because of this, it is not recommended to use this medicine during pregnancy unless the potential benefit of treatment outweighs any risks to the developing baby.

Women who are pregnant, or planning to become pregnant should tell their doctor before starting Breo Ellipta. Women who become pregnant while taking this medicine should tell their healthcare provider as soon as possible. It is also unknown whether Breo Ellipta can be passed via breast milk, but similar medications have been shown to do so. Women who are breastfeeding or who plan to breastfeed while taking Breo Ellipta should consult their healthcare provider.

Dosing

Use Breo Ellipta exactly as prescribed by your healthcare provider. If you take too much, seek medical attention immediately.^1,2

For additional information on Breo Ellipta, read the full prescribing information.