Breo Ellipta

Chronic Obstructive Pulmonary Disease (COPD)

Breo Ellipta is used for the long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and emphysema. It is also indicated to reduce the frequency of COPD exacerbations, which are periods when breathing symptoms suddenly get worse.

Asthma

This medication is used as a daily maintenance treatment for asthma in adults and children 5 years of age and older. It helps to prevent symptoms such as wheezing, chest tightness, and shortness of breath by improving lung function over time.

Usage Considerations

Breo Ellipta is intended for regular, long-term use. It is not used to treat:

• Acute symptoms: It will not replace a rescue inhaler for sudden breathing problems or asthma attacks.
• Occasional asthma: It is typically prescribed for patients whose asthma is not well-controlled on other long-term medications or whose disease severity requires multiple types of treatment.

Mechanism of Action

Breo Ellipta contains two active ingredients that target different aspects of respiratory conditions like asthma and chronic obstructive pulmonary disease (COPD):

• Fluticasone furoate: This is an inhaled corticosteroid. It works by decreasing the body's inflammatory response in the lungs. By reducing swelling and irritation in the airways, it helps prevent symptoms from starting.
• Vilanterol: This is a long-acting beta2-adrenergic agonist (LABA). It works by stimulating receptors in the muscles surrounding the airways, causing them to relax. This process, known as bronchodilation, helps keep the airways open for an extended period.

Because vilanterol is long-acting, the medication is typically used once daily to provide continuous airway support. It is important to note that Breo Ellipta is designed for long-term maintenance and does not work fast enough to treat a sudden asthma attack or respiratory distress.

Common Side Effects

• Headache
• Sore throat or runny nose
• Cough
• Hoarseness or voice changes
• Back or joint pain
• Stomach pain
• Thrush (white patches in the mouth or throat)

Serious Side Effects

• Pneumonia, particularly in patients with COPD
• Weakened immune system and increased risk of infections
• Adrenal gland problems, which may cause extreme tiredness or weakness
• Sudden breathing problems immediately after using the inhaler
• Bone thinning or increased risk of fractures
• Eye problems, including glaucoma, cataracts, or blurred vision
• Heart rhythm changes, such as a fast or irregular heartbeat
• Severe allergic reactions, including rash, hives, or swelling of the face and tongue

Acute Symptoms

Breo Ellipta should not be used to treat sudden, severe symptoms of asthma or COPD. It is a maintenance medication and will not replace a rescue inhaler for immediate relief of an asthma attack or breathing emergency.

Infections and Immune System

This medication contains a corticosteroid which can affect the immune system and increase the risk of certain infections:

• Oral Thrush: Fungal infections (candidiasis) can develop in the mouth and throat. Rinsing the mouth with water without swallowing after each dose helps reduce this risk.
• Pneumonia: There is an increased risk of developing pneumonia in people with COPD who use this medication.
• Existing Infections: Inhaled steroids may worsen existing tuberculosis, fungal, bacterial, viral, or parasitic infections.

Cardiovascular and Metabolic Effects

The vilanterol component of this medication can cause significant cardiovascular effects in some individuals. Caution is advised for those with heart disease, high blood pressure, or heart rhythm disorders. Additionally, the medication may lead to:

• Increased pulse rate or blood pressure.
• Changes in blood sugar levels (hyperglycemia).
• Low potassium levels in the blood (hypokalemia).

Long-term Use Risks

Prolonged use of inhaled corticosteroids may lead to several systemic issues:

• Bone Density: Long-term use may result in a decrease in bone mineral density, which is a risk factor for osteoporosis.
• Eye Problems: Users may have an increased risk of developing glaucoma or cataracts. Regular eye examinations may be necessary.
• Adrenal Suppression: Particular care is needed when patients are transferred from oral steroids to inhaled steroids, as adrenal insufficiency can occur.

Additional Precautions

Breo Ellipta may cause paradoxical bronchospasm, a condition where breathing becomes worse immediately after using the inhaler. If this occurs, the medication should be discontinued. It should also be used with caution in individuals with seizure disorders, thyroid problems, or severe liver impairment.

Pregnancy

It is not currently known if Breo Ellipta will harm an unborn baby. If you are pregnant or planning to become pregnant, you should consult your healthcare provider to discuss whether the benefits of using this medication outweigh the potential risks. While animal studies have shown some risks with high doses of corticosteroids, human data is limited.

One of the active ingredients in Breo Ellipta, vilanterol, belongs to a class of drugs called long-acting beta2-agonists (LABAs). These medications may interfere with uterine contractions during labor and delivery. Because of this potential effect, the use of Breo Ellipta during labor should be carefully managed by a medical professional.

Breastfeeding

It is unknown if the active ingredients in Breo Ellipta, fluticasone and vilanterol, pass into human breast milk. There is also no information available regarding the medication's effect on milk production or its impact on a nursing infant. If you are breastfeeding or planning to breastfeed, talk to your doctor about the safest way to manage your condition.

Available Forms

Breo Ellipta is supplied as a dry powder for oral inhalation. The medication is contained within a plastic inhaler device that includes the following features:

• Inhalation Powder: The active ingredients are formulated as a dry powder stored in separate foil blister strips inside the device.
• Inhaler Device: A disposable plastic inhaler designed to deliver the combined medications each time it is activated.
• Dose Counter: The device features a built-in counter to track the number of remaining doses.

This medication is intended for oral inhalation only and should not be used with a spacer device.

FDA Approval History

The U.S. Food and Drug Administration (FDA) first approved Breo Ellipta in May 2013. It was initially indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It was also approved to reduce exacerbations of COPD in patients with a history of flare-ups.

In 2015, the FDA expanded the approval of Breo Ellipta to include the treatment of asthma in adults aged 18 years and older. This indication was further expanded in 2020 to include pediatric patients aged 12 years and older.

Regulatory Status and Safety

Breo Ellipta is classified as a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA). While LABA medications previously carried a boxed warning regarding the risk of asthma-related death, the FDA removed this warning requirement for ICS/LABA combination products in late 2017. This decision followed a review of large safety clinical trials that demonstrated these combination products do not significantly increase the risk of serious asthma-related events compared to inhaled corticosteroids alone.

The medication is approved for maintenance treatment only and is not indicated for the relief of acute bronchospasm, also known as rescue therapy. It is not available as an over-the-counter product.

Factors Influencing Price

The retail price of Breo Ellipta is influenced by several factors, including your location and the specific pharmacy you visit. Because it is a brand-name medication, it is generally more expensive than generic alternatives.

Generic Availability

A generic version of the fluticasone furoate and vilanterol combination is available. Generic drugs typically cost less than brand-name versions because they do not require the same initial research and development costs.

Insurance and Assistance

Most insurance plans, including Medicare and Medicaid, cover Breo Ellipta, though the specific copay amount depends on the plan tier system. For those without insurance or with high out-of-pocket costs, the manufacturer may offer patient assistance programs or savings cards to help lower the price. It is advisable to compare prices at different pharmacies and check for available coupons before filling a prescription.