近日，美国FDA批准梯瓦制药研发的哮喘的新产品-ArmonAirRespiClick，用于年龄≥12岁的哮喘患者的维持用药，并预防哮喘加重。

批准日期：2017年2月20日 公司：梯瓦制药（Teva）

ARMONAIR RESPICLICK（丙酸氟替卡松 fluticasone propionate）吸入粉末55 mcg

ARMONAIR RESPICLICK（丙酸氟替卡松 fluticasone propionate）吸入粉末113 mcg

ARMONAIR RESPICLICK（丙酸氟替卡松 fluticasone propionate）吸入粉末232 mcg

用于口服吸入

最初的美国批准：1994年

适应症和用法

ARMONAIR RESPICLICK是一种皮质类固醇，适用于：

•维持治疗哮喘作为12岁及以上患者的预防性治疗。

重要使用限制：

•未指出缓解急性支气管痉挛。

作用机制

丙酸氟替卡松是一种具有抗炎活性的合成三氟化皮质类固醇。丙酸氟替卡松在体外已显示出对人糖皮质激素受体的结合亲和力是地塞米松的18倍，几乎是二丙酸倍氯米松的活性代谢产物倍氯米松-17-单丙酸酯（BMP）的两倍，是布地奈德的3倍以上。来自的数据人体中的McKenzie血管收缩剂测定与这些结果一致。

这些发现的临床意义尚不清楚。炎症是哮喘发病机制中的重要组成部分。皮质类固醇已显示出对多种细胞类型（例如，肥大细胞，嗜酸性粒细胞，嗜中性粒细胞，巨噬细胞和淋巴细胞）和参与炎症的介质（例如组胺，类二十烷酸，白三烯和细胞因子）具有广泛的作用。皮质类固醇的这些抗炎作用有助于它们在哮喘中的功效。

虽然有效治疗哮喘，但皮质类固醇不会立即影响哮喘。个体患者将经历可变时间的症状缓解程度。开始治疗后1至2周或更长时间内可能无法获得最大益处。

当停用皮质类固醇时，哮喘稳定性可持续数天或更长时间。

哮喘患者的试验显示，局部抗炎活性与全身皮质类固醇作用之间的比例与推荐剂量的口服吸入丙酸氟替卡松有关。这可以通过相对较高的局部抗炎作用，可忽略的口服全身利用度（<1％）和人体中检测到的唯一代谢物的最小药理活性的组合来解释。

剂量和给药

仅用于口服吸入。

•起始剂量基于先前的哮喘治疗和疾病严重程度。

•12岁及以上患者的哮喘治疗：每天两次吸入ARMONAIRRESPICLICK 55 mcg，113 mcg或232 mcg。

•请勿使用垫片或容量保持腔。

剂量形式和强度

•每次驱动含有55 mcg，113 mcg或232 mcg丙酸氟替卡松的吸入粉末。

禁忌症

•哮喘状态或其他急性哮喘发作的主要治疗需要采取强化措施。

•对牛奶蛋白质或ARMONAIR RESPICLICK的任何成分严重超敏反应。

警告和注意事项

•局部感染：白色念珠菌感染口腔和咽喉可能发生。定期监测患者。建议患者在吸入后不用吞咽水冲洗他/她的嘴。

•哮喘和急性发作的恶化：不要用于缓解急性症状。

患者需要在快速恶化的哮喘期间立即重新评估。

•免疫抑制：现有结核病，真菌，细菌，病毒，寄生虫感染或单纯眼单纯疱疹的潜在恶化。对患有这些感染的患者慎用。在易感患者中发生更严重甚至致命的水痘或麻疹。

•从全身性皮质类固醇转移患者：从全身性皮质类固醇转移时肾上腺功能受损的风险。如果转移到ARMONAIR RESPICLICK，则从全身性皮质类固醇缓慢减量。

•高度主动脉和肾上腺抑制：可能以非常高的剂量或在

易感个体的常规剂量。如果发生此类变化，请停止

ARMONAIR RESPICLICK慢慢来。

•骨密度降低：监测患有骨矿物质含量降低的主要危险因素的患者。

•监测儿科患者的增长情况。

•有必要密切监测青光眼和白内障。

•矛盾性支气管痉挛：如果出现矛盾性支气管痉挛，请停止ARMONAIR RESPICLICK并进行替代治疗。

不良反应

最常见的不良反应（报告大于或等于3％的受试者）是：鼻咽炎，上呼吸道感染，口腔念珠菌病，头痛和咳嗽。

要报告疑似不良反应，请联系Teva Respiratory，LLC，电话：1-888-482-9522，或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。

药物相互作用

强细胞色素P450 3A4抑制剂（例如利托那韦，酮康唑。

如何提供/存储和处理

如何提供

ARMONAIR RESPICLICK具有以下三种强度作为whitedry-powder吸入器。每个吸入器都有一个绿色的帽子，并在纸箱中单独包装在一个小袋中。每个吸入器含有0.9克配方，并提供60次驱动：

强大的NDC代码

ARMONAIR RESPICLICK 55mcg NDC 59310-705-06

ARMONAIR RESPICLICK 113mcg NDC 59310-711-06

ARMONAIR RESPICLICK 232mcg NDC 59310-722-06

每个ARMONAIR RESPICLICK吸入器都有一个与执行器相连的剂量计数器。

患者不应该试图改变剂量计数器的数量。计数器显示在打开铝箔袋后0天，30天或产品有效期后（以先到者为准）显示时，请丢弃吸入器。在计数器显示0，偶数之后，不能确保每次致动中的标记量

虽然吸入器不是完全空的并且将继续运行[见患者咨询信息]。

存储和处理

在室温下（15°至25°C; 59°至77°F）储存在干燥的地方;允许偏移59°F至86°F（15°C至30°C）。避免接触极端

热，冷或湿度。

请将本品放在儿童不能接触的地方。

ARMONAIR RESPICLICK应存放在未开封的防潮装置内铝箔袋，仅在初次使用前立即从袋中取出。丢弃打开铝箔袋或柜台后30天ARMONAIR RESPICLICK读取“0”，以先到者为准。吸入器不可重复使用。不要试图采取吸入器分开了。

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ArmonAir RespiClick(Fluticasone Propionate Multidose Dry Powder Inhaler for Oral Inhalation)

ArmonAir™ RespiClick® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older. 

Important Limitation of Use: ArmonAir™ RespiClick® is NOT indicated for the relief of acute bronchospasm. 

IMPORTANT SAFETY INFORMATION

•Contraindications: ArmonAir™ RespiClick® is contraindicated in: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required

Patients with known severe hypersensitivity to milk proteins or known hypersensitivity to fluticasone propionate or any of the excipients

•Local Effects: Oropharyngeal candidiasis has occurred in patients treated with ArmonAir™ RespiClick®. Advise patients to rinse the mouth with water without swallowing following inhalation 

•Acute Asthma Episodes: ArmonAir™ RespiClick® is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir™ RespiClick®, should be used to relieve acute symptoms such as shortness of breath

•Immunosuppression: Patients on corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution, if at all, in patients with the above because of the potential for worsening of these infections

•Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Slowly taper the dose of systemic corticosteroids if transferring patients to ArmonAir™ RespiClick®

•Hypercorticism and Adrenal Suppression: Because of the possibility of significant systemic absorption of inhaled corticosteroids, patients on ArmonAir™ RespiClick® should be observed carefully for any evidence of systemic corticosteroid effects. If such effects occur, the dosage of ArmonAir™ RespiClick® should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and for management of asthma symptoms

•Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir™ RespiClick®. Discontinue ArmonAir™ RespiClick® if such reactions occur

•Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care

•Effect on Growth: Inhaled corticosteroids, including ArmonAir™ RespiClick®, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ArmonAir™ RespiClick® routinely (e.g., via stadiometry). Titrate to the lowest dosage that effectively controls symptoms

•Glaucoma and Cataracts: Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma following the long-term administration of inhaled corticosteroids, including fluticasone propionate. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts

•Paradoxical Bronchospasm: Bronchospasm may occur with an immediate increase in wheezing after dosing and should be treated immediately with an inhaled, short-acting bronchodilator; ArmonAir™ RespiClick® should be discontinued immediately and alternative therapy instituted

•Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ArmonAir™ RespiClick® is not recommended because increased systemic corticosteroid adverse effects may occur

•Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroids following the introduction of fluticasone propionate. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy

•Adverse Reactions: Most common adverse reactions (≥3%) in patients taking ArmonAir™ RespiClick® 55 mcg twice daily, 113 mcg twice daily, 232 mcg twice daily, and placebo, respectively, were nasopharyngitis (5.4%, 5.8%, 4.8%, 4.4%), upper respiratory tract infection (5.4%, 4.7%, 5.5%, 4.8%), oral candidiasis (3.1%, 2.9%, 4.8%, 0.7%), headache (1.6%, 7.3%, 4.8%, 4.4%), and cough (1.6%, 1.8%, 3.4%, 2.6%)

•Drug Interactions: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ArmonAir™ RespiClick® is not recommended because increased systemic corticosteroid adverse effects may occur

•Use in Specific Populations: Since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. Patients with hepatic disease should be closely monitored