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ANORO ELLIPTA混合吸入粉剂
(umeclidinium and vilanterol) Inhalation Powder
商品名：Anoro Ellipta
通用名：umeclidinium/vilanterol
中文名：芜地溴铵/维兰特罗
活性成分：
芜地溴铵（umeclidinium bromide）和维兰特罗（vilanterol）
适应症：
长期维持治疗慢性阻塞性肺病。
作用机理：
芜地溴铵是一种长效胆碱受体拮抗剂（LAMA），维兰特罗是一种长效肾上腺素β2受体激动剂(LABA)，都能够舒张支气管平滑肌。
剂型规格：
本品为口腔吸入粉，每天用药一次，每次62.5mg芜地溴铵+25mg维兰特罗。
药企：GlaxoSmithKline
ANORO ELLIPTA Rx
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:
4/8/2014
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