Vilanterol + Umeclidinium + Fluticasone Furoate

Vilanterol + Umeclidinium + Fluticasone Furoate is used for: Maintenance treatment of Chronic Obstructive Pulmonary Disease, Asthma

Inhalation Chronic Obstructive Pulmonary Disease Indicated for long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) 1 inhalation (25 mcg/62.5 mcg/100 mcg) by PO inhalation once daily. Asthma Indicated for maintenance treatment of asthma in patients aged >18 years 1 inhalation (25 mcg/62.5 mcg/100 mcg) by PO inhalation once daily. No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with mild hepatic impairment

Oral Inhalation Preparation Inhaler contains 30 doses Do not open the cover of inhaler until ready to use it Oral Inhalation Administration Breathe out, inhale medicine Do not breathe in through the nose Do not block the air vent with fingers Remove the inhaler from mouth and hold breath for about 3-4 seconds Breathe out slowly and gently Rinse mouth with water after using inhaler and spit the water out to reduce risk of oropharyngeal candidiasis; do not swallow the water Close inhaler Administer at the same time each day; do not use more than once/24 hr

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

LABA monotherapy increases the risk of serious asthma-related events. Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms. Do not use in combination with additional therapy containing a LABA because of risk of overdose. Use caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; consider discontinuing therapy if such effects occur Assess bone mineral density (BMD) prior to initiating therapy and periodically thereafter; decreases in BMD have been observed with long-term administration of products containing ICS; if significant reductions in BMD are seen and therapy is still necessary, use of medicine to treat or prevent osteoporosis should be strongly considered Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with COPD following long-term administration of ICS or with use of inhaled anticholinergics; closely monitor patients with vision changes or with a history of increased intraocular pressure, narrow- or open-angle glaucoma, and/or cataracts Use caution in patients with urinary retention; monitor for signs and symptoms of urinary retention (eg, difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction; patients should consult healthcare provider if signs or symptoms develop Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia. If paradoxical bronchospasm occurs, discontinue and institute alternative therapy. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis 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.

Pregnancy There are insufficient data in pregnant women to inform a drug-associated risk In women with poorly or moderately controlled asthma, there is increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in neonate Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma May be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility Animal data Umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits not associated with adverse effect on embryofetal development at exposures approximately 40 and 150 times, respectively, the human exposure at the maximum recommended human daily inhalation doses (MRHDID) Lactation There is no information available on presence of fluticasone furoate, umeclidinium, or vilanterol in human milk; effects on breastfed child; or on milk production Umeclidinium was detected in plasma of offspring of lactating rats treated with umeclidinium, suggesting its presence in maternal milk Consider developmental and health benefits of breastfeeding along with mother’s clinical need for treatment and any potential adverse effects on the breastfed child from fluticasone furoate, umeclidinium, or vilanterol or from the underlying maternal condition

Side effects of Vilanterol + Umeclidinium + Fluticasone Furoate : >10% (Asthma) Pharyngitis/nasopharyngitis (15-17%) 1-10% (Asthma) 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%) 1-10% (COPD) Headache (4%) Back pain (4%) Diarrhea (2%) Dysgeusia (2%) Cough (1%) Oropharyngeal pain (1%) Gastroenteritis (1%) >1% Upper respiratory tract infection Pneumonia Bronchitis Oral candidiasis Arthralgia Influenza Sinusitis Pharyngitis Rhinitis Constipation Urinary tract infection Dysphonia

Umeclidinium bromide: Long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic; blocks action of acetylcholine at muscarinic receptors (M1 to M5) in the bronchial airways (M3) by preventing increase in intracellular calcium concentration, leading to relaxation of airway smooth muscle, improved lung function, and decreased mucous secretion; dissociates slowly from M3 muscarinic receptors extending its duration of action Vilanterol: Long-acting selective beta2-adrenergic agonist (LABA); stimulates intracellular adenyl cyclase resulting in increased cAMP levels causing bronchial smooth muscle relaxation; also inhibits release of mediators of immediate hypersensitivity from cells, especially from mast cells Fluticasone: Anti-inflammatory corticosteroid; exact mechanism of action is unknown, but agent has been shown to exhibit anti-inflammatory effect on neutrophils, eosinophils, macrophages, mast cells, lymphocytes, and mediators (histamine, leukotrienes, cytokines, eicosanoids)