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美国食品药品管理局2011年7月1日批准Arcapta Neohaler（indacaterol吸入型粉末剂）治疗慢性支气管炎、肺气肿等慢性阻塞性肺病(COPD)患者气流阻塞，用于每日1次长期维持支气管扩张剂治疗。 COPD是一种使呼吸困难的严重肺病。症状包括呼吸急促、慢性咳嗽和痰多。吸烟是COPD的主要根源，据疾病控制与预防中心报告，COPD在美国是第四大死因。 六项临床试验纳入5474名40岁及以上确诊的COPD患者，证明了Arcapta Neohaler的安全性及有效性。受试者有每天至少一包烟长达10年的吸烟史，且表现出肺功能中至重度的减弱。 Arcapta Neohaler说明书标有黑框警告信息：长效β2-肾上腺素能受体激动剂(LABA)可增加哮喘相关死亡风险；包括Arcapta Neohaler在内的所有LABA不应用于哮喘患者，除非作为长期哮喘控制药物使用。 FDA批准的Arcapta Neohaler用药指南表明，使用Arcapta Neohaler的患者报告的最常见副作用包括流鼻涕、咳嗽、咽喉痛、头痛、呕吐。 ARCAPTA NEOHALER Manufacturer:Novartis Pharmaceuticals Corp Pharmacological Class:Long-acting beta2-agonist (LABA). Active Ingredient(s):Indacaterol 75mcg; inhalation pwd hard capsules for use with Neohaler device. Indication(s):Long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and/or emphysema. Pharmacology:Indacaterol is a long-acting beta2-adrenergic agonist. When inhaled, indacaterol acts locally in the lung as a bronchodilator. The pharmacological effects of beta2-adrenoceptor agonist drugs, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’, 5’-adenosine monophosphate (cyclic monophosphate). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle. Clinical Trials:The Arcapta Neohaler COPD clinical development program included three dose-ranging trials and six confirmatory trials. After the initial 2-week dose-ranging portion of the design, Trial 3 was conducted with Arcapta Neohaler doses of 150mcg and 300mcg once daily, placebo, and an active comparator. Trials 4 and 5 were conducted with Arcapta Neohaler dose of 75mcg once daily, and placebo. Trial 6 was conducted with Arcapta Neohaler dose of 150mcg once daily and placebo. Trial 7 was conducted with Arcapta Neohaler dose of 150mcg once daily, an active comparator, and placebo. Trial 8 was conducted with Arcapta Neohaler doses of 300mcg and 600mcg once daily, an active comparator, and placebo. These six trials enrolled 5474 patients with a clinical diagnosis of COPD. Assessment of efficacy in these six COPD trials was based on FEV1. The primary efficacy endpoint was 24-hour post-dose trough FEV1 (defined as the average of two FEV1 measurements taken after 23 hours 10 minutes and 23 hours and 45 minutes after the previous dose) after 12 weeks of treatment in all 6 trials. Other efficacy variables included other FEV1 and FVC time points, rescue medication use, symptoms, and health-related quality of life measured using the St. George’s Respiratory Questionnaire (SGRQ). In all six confirmatory COPD trials, all doses of Arcapta Neohaler tested showed significantly greater 24-hour post-dose trough FEV1 compared to placebo at 12 weeks. Legal Classification:Rx Adults:For oral inhalation use only with Neohaler device; do not swallow caps. Remove cap from blister pack immediately before use. Inhale contents of one 75mcg cap daily. Children:Not established. Contraindication(s):LABA use in asthma patients without use of long-term control medication. Warnings/Precautions:LABA increase risk of asthma-related death. Not recommended for treating asthma or acute deteriorations of COPD. Do not exceed recommended dose. Not for primary treatment of acute symptoms. Discontinue if paradoxical bronchospasm or cardiovascular effects occur. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Severe hepatic impairment. Thyrotoxicosis. Hypokalemia. Hyperglycemia. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Pregnancy (Cat.C). Labor & delivery. Nursing mothers. Interaction(s):See Contraindications. Avoid other sympathomimetics (except short-acting bronchodilators). Extreme caution with MAOIs, tricyclics, others that prolong QTc interval. Antagonized by β-blockers. K+-depleting diuretics, theophylline, aminophylline, steroids may potentiate hypokalemia. Adverse Reaction(s):Cough, oropharyngeal pain, nasopharyngitis, headache, nausea. How Supplied:Caps—30 (5 blister cards x 6 caps) + one Neohaler inhaler Last Updated:4/16/2012
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