Umeclidinium/Vilanterol/Fluticasone

DEA Class; Rx

Common Brand Names; Trelegy Ellipta

• Anticholinergics, Respiratory; 
• Beta2 Agonists; 
• Corticosteroids, Inhalants; 
• Respiratory Inhalant Combos

Severe hypersensitivity to milk proteins

Hypersensitivity to fluticasone furoate, umeclidinium, vilanterol, or any of the excipients

Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required

• Pharyngitis/nasopharyngitis (15-17%)
• Headache (5-9%)
• Upper respiratory tract infection (5-7%)
• Bronchitis (4-5%)
• Respiratory tract infection (3-4%)
• Influenza (1-4%)
• Sinusitis (2-3%)
• Back pain (2-3%)
• Rhinitis (1-2%)
• Urinary tract infection (<1 to 2%)
• Dysphonia (1%)
• Oropharyngeal pain (1%)
• Pneumonia (<1 to 1%)
• Cough (<1 to 1%)

Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroid [ICS]) for asthma associated with increased risk of asthma-related death; data from controlled clinical trials suggest that LABA monotherapy increases risk of asthma-related hospitalization in pediatric and adolescent patients; available data from clinical trials in patients with COPD do not suggest an increased risk of death with use of LABA in patients with COPD; additionally, LABAs used in fixed-dose combination with ICS, data from large clinical trials do not show significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs; avoid using higher doses than recommended, or in conjunction with other medicines containing LABAs

Localized infections of the mouth and pharynx with Candida albicans reported with orally inhaled corticosteroids; when infection occurs, treat with appropriate local/systemic (ie, oral) antifungal therapy; advise the patient to rinse mouth with water without swallowing following inhalation to reduce oropharyngeal candidiasis risk

Lower respiratory tract infections, including pneumonia, reported following administration inhaled corticosteroids

Caution with ICSs in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex

Life-threatening paradoxical bronchospasm may occur; if this occurs, treat immediately with inhaled, short-acting bronchodilator; discontinue treatment immediately and institute alternant therapy

Hypersensitivity reactions (eg, anaphylaxis, angioedema, rash, urticaria) may occur

Use caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; consider discontinuing therapy if such effects occur

There are insufficient data in pregnant women to inform a drug-associated risk

There is no information available on presence of fluticasone furoate, umeclidinium, or vilanterol in human milk; effects on breastfed child; or on milk production

Fluticasone furoate/umeclidinium/vilanterol

powder for inhalation

• Kit contains 2 foil strips, each with 30 blisters: 1 strip contains fluticasone furoate (100mcg or 200mcg per blister); the other strip contains combination of umeclidinium and vilanterol (62.5mcg and 25mcg per blister)
• 100 mcg/62.5 mcg/25 mcg
• 200 mcg/62.5 mcg/25 mcg