IMPORTANT SAFETY INFORMATION
ANORO ELLIPTA is only approved for use in chronic obstructive pulmonary disease (COPD). ANORO is NOT approved for use in asthma. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in ANORO), have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD.
Pharmacological Class:
Anticholinergic + long-acting beta2-agonist.
Active Ingredient(s):
Umeclidinium 62.5mcg, vilanterol 25mcg; per inhalation; dry powder for oral inhalation.
Company
GlaxoSmithKline Pharmaceuticals
Indication(s):
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.
Pharmacology:
Umeclidinium, a long-acting antimuscarinic agent, inhibits the M3 receptor at the smooth muscle leading to bronchodilation. Vilanterol, a long-acting β2-agonist, relaxes bronchial smooth muscle and inhibits the release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Clinical Trials:
The efficacy of Anoro Ellipta is primarily based on 6 dose-ranging trials in 1,908 subjects with COPD or asthma and 2 placebo-controlled confirmatory trials with additional support from the 2 active-controlled and 2 crossover trials in 5,388 subjects with COPD.
The umeclidinium dose selection was supported by a 7-day placebo-controlled crossover trial evaluating 4 doses (15.6–125mcg) or placebo in 163 patients with COPD. The 62.5 and 125mcg doses showed larger improvements in FEV1 over 24 hours vs. the lower doses of 15.6 and 31.25mcg. The vilanterol dose selection was supported by a 28-day, placebo-controlled, parallel-group trial evaluating 5 doses (3–50mcg) or placebo in 602 patients with COPD. Results demonstrated dose-related increases in FEV1 vs. placebo at Day 1 and Day 28. The results supported the selection of the vilanterol 25mcg once-daily dose for further evaluation in the confirmatory COPD trials.
A placebo-controlled trial evaluated Anoro Ellipta (umeclidinium/vilanterol 62.5mcg/25mcg), umeclidinium 62.5mcg, vilanterol 25mcg, and placebo. At Day 169, the differences in the least squares mean change from baseline in trough FEV1 for Anoro Ellipta relative to placebo, umeclidinium 62.5mcg, and vilanterol 25mcg were 167mL (95% CI: 128, 207), 52mL (95% CI: 17, 87) and 95mL (95% CI: 60, 130), respectively.
For more clinical trial data, see full labeling.
Legal Classification:
Rx
Adults:
1 inhalation once daily.
Children:
Not established.
Contraindication(s):
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 (Category C). Nursing mothers: not recommended.
Interaction(s)
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 Reaction(s)
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 powder inhaler—30 doses
LAST UPDATED:
4/28/2014
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。