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美国FDA于2013年5月10日批准Breo Ellipta吸入性粉末用于治疗慢性阻塞性肺病（COPD,包括慢性支气管炎和肺气肿）的长期维持性治疗（1日1次）,也可用于减少和预防COPD急性加重疾病。
BREO ELLIPTA
Generic Name and Formulations:
Fluticasone furoate 100mcg, vilanterol 25mcg; per inhalation; dry pwd for oral inhalation.
Company:
GlaxoSmithKline Pharmaceuticals
Indications for BREO ELLIPTA:
Long term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. To reduce exacerbations of COPD in patients with a history of exacerbations. Limitations of use: not indicated for relief of acute bronchospasm or for treatment of asthma.
Adult Dose for BREO ELLIPTA:
1 inhalation once daily. Rinse mouth after use.
Children's Dose for BREO ELLIPTA:
Not established.
Pharmacological Class:
Corticosteroid + long-acting β2 agonist.
Contraindications:
Severe hypersensitivity to milk proteins.
Warnings/Precautions:
Increased risk of asthma-related deaths. Do not initiate in rapidly or acutely deteriorating COPD. Not for relief of acute bronchospasm. Not for use with other long-acting β2-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Monitor for adrenal insufficiency when transferring from systemic steroids. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), intraocular pressure, glaucoma, or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Moderate or severe hepatic impairment; monitor. Assess bone mineral density if risk factors exist (eg, osteoporosis, postmenopausal). Labor and delivery. Pregnancy (Cat. C). Nursing mothers.
Interactions:
Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole). Caution with concomitant MAOIs, tricyclic antidepressants, or drugs known to prolong the QT interval or within 2 weeks of discontinuing such agents (increased cardiac effects), K+-depleting diuretics. Antagonized by β-blockers.
Adverse Reactions:
Nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis; risk of asthma-related death.
How Supplied:
Dry pwd inhaler—30 doses
美国FDA批准复方干粉吸入剂Breo Ellipta用于慢性阻塞性肺病(COPD)患者的维持治疗
2013年5月10日，美国食品药品管理局(FDA0)和葛兰素史克公司宣布Breo Ellipta(肾上腺皮质激素氟替卡松100μg+长效β受体激动剂维兰特罗25μg),获准用作慢性阻塞性肺病(COPD)患者气流阻塞的维持治疗，包括慢性支气管炎和(或)肺气肿。对于有加重病史的患者，该药还适用于减少其COPD加重的发作次数。Breo Ellipta用于哮喘患者的安全性和有效性尚未得到证实，故未获准用于哮喘患者。
Breo Ellipta的安全性和有效性评估涉及7,700例临床诊断为COPD的患者。研究结果显示，与安慰剂相比，接受该药治疗的患者肺功能改善，加重的发作次数减少。
在2项为期6个月的Breo Ellipta(与安慰剂对比)临床试验中报告最多的不良反应是鼻咽炎、上呼吸道感染、头痛及口腔念珠菌病。除了这2项试验中报告的不良事件外，在另外2项为期1年的研究中，一些患者在接受Breo Ellipta治疗期间还会出现COPD、背痛、肺炎、支气管炎、鼻窦炎、咳嗽、口咽痛、关节痛、高血压、流感、咽炎、腹泻、周围水肿及发热等不良事件。
该药物的标签中有一个黑框警告，内容为长效β2激动剂(LABAs)(如维兰特罗)可增加哮喘相关死亡的风险。Breo Ellipta不宜在COPD快速恶化或发生潜在致死性发作期间开始用药，也不宜作为支气管痉挛急性发作的抢救治疗药。使用Breo Ellipta可能发生的严重不良事件包括肺炎和骨折。
Breo Ellipta是一种每日1次用药的长期吸入性药品，且若不出意外,本品也有望很快在欧盟和日本获准上市。 | 
