ARNUITY ELLIPTA 糠酸氟替卡松吸入粉剂 (fluticasone furoate,FF) - America[美国药品]

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ARNUITY ELLIPTA 糠酸氟替卡松吸入粉剂 (fluticasone furoate,FF)

2015-01-03 20:09:34 来源: 作者: 【大中小】浏览:526次评论:0条

2014年8月26日，FDA已批准Arnuity Ellipta（糠酸氟替卡松吸入粉剂），作为一种预防性疗法（prophylactic therapy），用于12岁及以上哮喘患者的维持治疗。Arnuity为每日一次的吸入性糖皮质激素（ICS）药物，不适用于急性支气管痉挛的缓解。
Arnuity Ellipta是一种糠酸氟替卡松（fluticasone furoate，FF）单药疗法，获批剂量为100mcg和200mcg，该药通过干粉吸入器Ellipta给药，其疗效和安全性已在大型临床项目中得到验证，涉及超过3600例哮喘患者。Ellipta干粉吸入器已广泛用于一系列其他已获批的呼吸药物。
Arnuity Ellipta的获批，也标志着葛兰素史克呼吸管线在一年多点时间内获FDA批准的第4个产品。其他3种产品分别为：Incruse Ellipta（umeclidinium，UMEC），该药为首个长效毒蕈碱受体拮抗剂（LAMA）单药疗法，用于慢性阻塞性肺病（COPD）的治疗；Breo Ellipta（fluticasone furoate/vilanterol，FF/VI），该药为每日1次的吸入型糖皮质激素糠酸氟替卡松(FF)和长效β2受体激动剂维兰特罗(VI)的复方药物，用于慢性阻塞性肺病（COPD）和哮喘的治疗；Anoro Ellipta（umeclidinium/vilanterol，UMEC/VI），该药为长效毒蕈碱受体拮抗剂（LAMA）UMEC（umeclidinium）和长效β2受体激动剂维兰特罗(VI，vilanterol)的复方药物，是GSK的一个独特产品，是获FDA批准的首个LAMA/LABA组合药物。
目前，葛兰素史克已计划扩大其在呼吸疾病领域的领先优势，与长期合作伙伴Theravance公司启动了COPD三联疗法（FF/UMEC/VI）的III期临床项目，该三联疗法（FF/UMEC/VI）是一种ICS/LAMA/LABA组合疗法，组成为：FF（Fluticasone furoate，糠酸氟替卡松，一种吸入性皮质类固醇，ICS）+UMEC（umeclidinium，一种长效毒蕈碱拮抗剂，LAMA）+VI（vilanterol，维兰特罗，一种长效β2受体激动剂，LABA）。该项目首个III期IMPACT将招募约1万例COPD患者，将调查三联疗法是否能降低COPD中度和重度发作（exacerbation）的年发作率。

Drug Name(s)	ARNUITY ELLIPTA
FDA Application No.	(NDA) 205625
Active Ingredient(s)	FLUTICASONE FUROATE
Company	GLAXOSMITHKLINE

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ARNUITY ELLIPTA safely and effectively. See full prescribing information for ARNUITY ELLIPTA.
ARNUITY ELLIPTA (fluticasone furoate inhalation powder) 100 mcg
ARNUITY ELLIPTA (fluticasone furoate inhalation powder) 200 mcg
FOR ORAL INHALATION
Initial U.S. Approval: 2014

INDICATIONS AND USAGE

ARNUITY ELLIPTA is a corticosteroid indicated for:

•: once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. (1.1)

Important limitation:

•: Not indicated for relief of acute bronchospasm. ( 1.1, 5.2)

DOSAGE AND ADMINISTRATION

For oral inhalation only. (2.1)

•: Starting dosage is based on prior asthma therapy and disease severity. ( 2.2)
•: Treatment of asthma in patients aged 12 years and older: 1 inhalation of ARNUITY ELLIPTA 100 mcg or ARNUITY ELLIPTA 200 mcg once daily. ( 2.2)

DOSAGE FORMS AND STRENGTHS

Inhalation powder containing 100 or 200 mcg of fluticasone furoate per actuation. (3)
CONTRAINDICATIONS

•: Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4.1)
•: Severe hypersensitivity to milk proteins or any ingredients of ARNUITY ELLIPTA. ( 4.2)
WARNINGS AND PRECAUTIONS

•: Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation. (5.1)
•: Deterioration of asthma and acute episodes: Do not use for relief of acute symptoms. Patients require immediate re-eva luation during rapidly deteriorating asthma. (5.2)
•: Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infections or ocular herpes simplex. Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.3)
•: Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to ARNUITY ELLIPTA. (5.4)
•: Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ARNUITY ELLIPTA slowly. (5.5)
•: Paradoxical bronchospasm: Discontinue ARNUITY ELLIPTA and institute alternative therapy if paradoxical bronchospasm occurs. (5.7)
•: Decreases in bone mineral density: Monitor patients with major risk factors for decreased bone mineral content.