Generic Name and Formulations:
Umeclidinium 62.5mcg, vilanterol 25mcg; per ­inhalation; dry pwd for oral inhalation.

Company:
GlaxoSmithKline Pharmaceuticals

 FDA批准AnoroEllipta治疗慢性阻塞性肺疾病

美国药品食品监督局（FDA）批准AnoroEllipta（umeclidinium和vilanterol的混合吸入粉剂）作为慢性阻塞性肺疾病（COPD）患者有气流受限的人的日常长期维持治疗用药。
COPD是一种能造成呼吸困难并随着时间推移进行性加重的严重肺部疾病。症状包括胸部紧迫感、慢性咳嗽和痰多。吸烟是导致COPD的首要原因。据美国国家心脏、肺和血液研究所称，在美国COPD是第三大死因。
“AnoroEllipta通过帮助舒张呼吸道周围的肌肉组织来增加COPD患者的通气量” FDA新药评审研究中心新药审评第二室主任，公共卫生学硕士和医学博士CurtisRosebraugh说，“这种有效的长期维护的新药为美国数以百万计的COPD患者提供了额外的治疗选择”
AnoroEllipta是umeclidinium和vilanterol的混合制剂。umeclidinium是一种作用于大气道周围平滑肌并阻断肌紧张的吸入性抗胆碱药。而vilanterol是一种长效β2受体激动药（LABA），可以通过舒张气道平滑肌使更多的气体进出肺组织以增强呼吸。
AnoroEllipta的安全性和有效性已经在2,400名确诊为COPD患者的身上得到了证实。治疗组与安慰剂组相比肺功能提高了。
这种药物携带有LABAs增加哮喘相关疾病死亡风险的黑框警告。AnoroEllipta对于哮喘患者的安全性和有效性尚未被确定，而且AnoroEllipta尚未被证实可以用于哮喘病的治疗。Anoro Ellipta不能用于急性呼吸问题（急性支气管痉挛）的急救治疗。
FDA核准了AnoroEllipta及其包括使用说明书和服药潜在风险信息在内的患者用药指导。AnoroEllipta可能造成严重的副作用，包括呼吸道狭窄和阻塞（矛盾性支气管痉挛）、心血管作用、眼压增高（狭角性青光眼）、尿潴留加重。使用AnoroEllipta被报道的最常见的副作用有咽喉痛（咽炎）、鼻窦感染（鼻窦炎）、下呼吸道感染、便秘、腹泻、疼痛、肌肉痉挛、项痛、胸痛。

Indications for ANORO ELLIPTA:

Long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. Limitations of use: not indicated for relief of acute bronchospasm or for treatment of asthma.

Adult Dose for ANORO ELLIPTA:

1 inhalation once daily.

Children's Dose for ANORO ELLIPTA:

Not established.

Pharmacological Class:

Anticholinergic + long-acting beta2-agonist.

Contraindications:

Severe hypersensitivity to milk proteins.

Warnings/Precautions:

Increased risk of asthma-related deaths. Do not initiate in rapidly or acutely deteriorating COPD. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Not for use with other long-acting β2-agonists. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Risk of hypokalemia or hyperglycemia. Labor and delivery. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions:

Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole), MAOIs, tricyclic antidepressants, 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; if needed, consider cardioselective agents. Additive effects with concomitant other anticholinergic drugs; avoid.

Adverse Reactions:

Pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck and chest pain; risk of asthma-related death.

How Supplied:

Dry pwd inhaler—30 doses