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® Asmanex HFA (mometasone furoate) — New Drug Approval • On December 10, 2014, Merck launched Asmanex HFA (mometasone furoate) inhalation aerosol, for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older. — Asmanex HFA is not indicated for the relief of acute bronchospasm. — Asmanex HFA contains a hydrofluoroalkane propellant. • Asthma is a chronic lung disease characterized by airway inflammation and defined by a history of respiratory symptoms. — According to the National Heart, Lung, and Blood Institute, over 22 million Americans are known to have asthma. — Common symptoms include wheezing, shortness of breath, chest tightness, and cough. • Asmanex HFA is an inhalation aerosol and contains the corticosteroid, mometasone furoate. Corticosteroids exhibit potent anti-inflammatory activity. ® ® — Asmanex Twisthaler is a related product. In contrast to Asmanex HFA, Asmanex Twisthaler is a cap-activated, inhalation-driven dry powder inhaler, for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. • The safety and efficacy of Asmanex HFA were based on placebo-controlled trials in patients 12 years of age and older with persistent asthma. — From baseline to week 12, the change in mean trough forced expiratory volume in 1 second (FEV1) was greater among patients receiving Asmanex HFA vs. placebo (treatment difference from placebo = 0.12L; 95% CI: 0.05, 0.20). — Fewer patients in the Asmanex HFA arm reported deteriorations in asthma or reductions in lung function compared to placebo (34% vs. 56%). • Asmanex HFA is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. • Warnings and precautions of Asmanex HFA include: deterioration of asthma and acute episodes, local effects, immunosuppression, transferring patients from systemic corticosteroid therapy, hypercorticism and adrenal suppression, drug interactions with strong cytochrome P450 3A4 inhibitors, paradoxical bronchospasm and upper airway symptoms, hypersensitivity reactions including anaphylaxis, reduction in bone mineral density, effect on growth, glaucoma, and cataracts. • The most common adverse reactions (≥ 3%) with Asmanex HFA use were nasopharyngitis, headache, sinusitis, bronchitis, and influenza. Continued . . . • The recommended dose of Asmanex HFA is 2 inhalations twice daily (morning and evening). The specific dose should be based on each patient’s prior asthma therapy. Previous Therapy Inhaled medium-dose corticosteroids Inhaled high-dose corticosteroids Oral corticosteroids Recommended Dose of Asmanex HFA 100 mcg: 2 inhalations twice daily 200 mcg: 2 inhalations twice daily 200 mcg: 2 inhalations twice daily — Asmanex HFA requires priming with 4 actuations (puffs) before initial use and if more than 5 days have elapsed since the last use of Asmanex HFA. • Asmanex HFA is available as a pressurized metered dose inhaler in 100 mcg and 200 mcg strengths. optumrx.com OptumRx specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. We are an Optum™ company — a leading provider of integrated health services. Learn more at optum.com. All Optum™ trademarks and logos are owned by Optum, Inc. All other brand or product names are trademarks or registered marks of their respective owners. ©2014 Optum, Inc. All rights reserved.