June 30, 2016
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Breo Ellipta

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Breo Ellipta

Indications
Dosage
How Supplied

INDICATIONS

Maintenance Treatment Of Chronic Obstructive Pulmonary Disease

BREO® ELLIPTA® 100/25 is a combination inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BREO ELLIPTA 100/25 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. BREO ELLIPTA 100/25 once daily is the only strength indicated for the treatment of COPD.

Important Limitation Of Use

BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm

Treatment Of Asthma

BREO ELLIPTA is a combination ICS/LABA indicated for the once-daily treatment of asthma in patients aged 18 years and older.

LABA, such as vilanterol, one of the active ingredients in BREO ELLIPTA, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Use In Specific Populations]. Therefore, when treating patients with asthma, physicians should only prescribe BREO ELLIPTA for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue BREO ELLIPTA) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use BREO ELLIPTA for patients whose asthma is adequately controlled on low-or medium-dose inhaled corticosteroids.

Important Limitation Of Use

BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

BREO ELLIPTA should be administered once daily every day by the orally inhaled route only.

BREO ELLIPTA should be taken at the same time every day. Do not use BREO ELLIPTA more than 1 time every 24 hours.

After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.

More frequent administration or a greater number of inhalations (more than 1 inhalation daily) of the prescribed strength of BREO ELLIPTA is not recommended as some patients are more likely to experience adverse effects with higher doses. Patients using BREO ELLIPTA should not use additional LABA for any reason. [See WARNINGS AND PRECAUTIONS]

Chronic Obstructive Pulmonary Disease

BREO ELLIPTA 100/25 should be administered as 1 inhalation once daily. The maximum recommended dosage is 1 inhalation of BREO ELLIPTA 100/25 once daily, the only strength indicated for the treatment of COPD.

If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

Asthma

If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

The recommended starting dosage is BREO ELLIPTA 100/25 or BREO ELLIPTA 200/25 administered as 1 inhalation once daily. The maximum recommended dosage is 1 inhalation of BREO ELLIPTA 200/25 once daily.

The starting dosage is based on patients' asthma severity. For patients previously treated with low-to mid-dose corticosteroid–containing treatment, BREO ELLIPTA 100/25 should be considered. For patients previously treated with mid-to high-dose corticosteroid–containing treatment, BREO ELLIPTA 200/25 should be considered.

The median time to onset, defined as a 100-mL increase from baseline in mean forced expiratory volume in 1 second (FEV1), was approximately 15 minutes after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to BREO ELLIPTA 100/25, increasing the dose to BREO ELLIPTA 200/25 may provide additional improvement in asthma control.

If a previously effective dosage regimen of BREO ELLIPTA fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the current strength of BREO ELLIPTA with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.

HOW SUPPLIED

Dosage Forms And Strengths

Inhalation powder: Disposable light grey and pale blue plastic inhaler containing 2 foil blister strips of powder intended for oral inhalation only. One strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains vilanterol (25 mcg per blister).

Storage And Handling

BREO ELLIPTA is supplied as a disposable light grey and pale blue plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:

NDC 0173-0859-10 BREO ELLIPTA 100/25 30 inhalations (60 blisters)
NDC
0173-0859-14 BREO ELLIPTA 100/25 14 inhalations (28 blisters), institutional pack
NDC
0173-0882-10 BREO ELLIPTA 200/25 30 inhalations (60 blisters)
NDC 0173-0882-14 BREO ELLIPTA 200/25 14 inhalations (28 blisters), institutional pack

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.

BREO ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard BREO ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: Feb 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/4/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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