Classes
DEA Class; Rx
Common Brand Names; Breo Ellipta
- Beta2 Agonists;
- Corticosteroids, Inhalants;
- Respiratory Inhalant Combos
Description
Combination inhaled corticosteroid (fluticasone) and a long-acting beta-2 adrenergic agonist (vilanterol)
Used once-daily in adults for the maintenance treatment of COPD and to reduce COPD exacerbations
Also used once-daily for the maintenance treatment of asthma in adults
Indications
Indicated for long-term, once-daily, maintenance treatment of airflow obstruction with COPD, including chronic bronchitis and/or emphysema; also approved to reduce COPD exacerbations
Indicated for once-daily treatment of asthma for patients not adequately controlled on a long-term asthma control medication (eg, inhaled corticosteroid), or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting beta agonist (LABA)
Contraindications
Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required
Hypersensitivity to drug, any components/excipients, or milk proteins
Adverse Effects
- Nasopharyngitis (9%)
- Upper respiratory infection (7%)
- Headache (7%)
- Oropharyngeal candidiasis (5%)
- Anxiety
- Tremors
- Palpitations, tachycardia
- Anaphylaxis, angioedema, rash, urticaria
- Muscle spasms
- Tremor
- Nervousness
- Paradoxical bronchospasm
- Hyperglycemia
Warnings
Not for treatment of acute episodes
Pregnancy and Lactation
Disease-associated maternal and/or embryofetal risk; in women with poorly or moderately controlled asthma, there is increased risk of several perinatal outcomes such as pre-eclampsia in mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma
There is no information available on presence of fluticasone furoate or vilanterol in human milk
Maximum Dosage
-COPD: 100 mcg/day of fluticasone and 25 mcg/day of vilanterol via oral inhalation.
-Asthma: 200 mcg/day of fluticasone and 25 mcg/day of vilanterol via oral inhalation.
-COPD: 100 mcg/day of fluticasone and 25 mcg/day of vilanterol via oral inhalation.
-Asthma: 200 mcg/day of fluticasone and 25 mcg/day of vilanterol via oral inhalation.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.