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部分中文TYVASO处方资料（仅供参考）
FDA批准TYVASO （Treprostinil）吸入剂用
联合治疗公司（United Therapeutics Corporation）宣布，美国食品药品监督管理局（FDA）已批准TYVASO （Treprostinil）吸入剂通过TYVASO吸入系统（包括Optineb-ir装置和附件）用于治疗肺动脉高压（PAH）。TYVASO适用于改善伴有与世卫组织（WHO）Ⅰ类疾病PAH相关的NYHA Ⅲ级症状的患者的步行距离，PAH可由多种病因引起，如先天性和家族性PAH以及硬皮病相关性PAH和先天性心脏病相关性PAH.
“对于在治疗这一严重心—肺疾病方面能够得到FDA的第四次批准，我们感到很激动”，联合治疗公司的主席兼首席执行官（CEO） Martine Rothblatt博士说到，“特别要承认的是德国的Werner Seeger和美国的Lew Rubin他们的关键性的前期努力，使这一新的治疗成为可能。我们成立这家公司时的希望和梦想在TYVASO的身上得到了体现。”
在TYVASO被批准的同时，联合治疗公司还同意了多项上市后承诺（PMC），包括对TYVASO吸入系统的某些方面进行改进、进行一项可用性分析并收集通过修改后的装置给予不同剂量时的药代动力学数据。“我们正在改进TYVASO的吸入系统”，联合治疗公司的负责人兼首席运营官（COO）Roger Jeffs博士说到，“并且我们认为这些改进将会使吸入装置变得更方便使用。届时，患者将使用通用版的装置。”我们已承诺最迟于2010年10月31日完成上述PMC.
另外，联合治疗公司已同意一项上市后要求（PMR），即进行一项长期观察性研究以评估在使用TYVASO的患者中的口咽和肺部毒副作用的风险。“我们欢迎有这么一个机会来进一步收集有关TYVASO安全性的信息”，Jeffs博士继续说到。我们已承诺最迟于2013年12月15日完成上述PMR.
在TRIUMPH-1随机、双盲、12周安慰剂对照性临床试验中，被每日4次给予TYVASO的患者在6分钟步行距离中增加了20米，高于给予安慰剂者（p＜0.0005）。尚未确认该药在伴有潜在性肺病的患者中的安全性和有效性。在安慰剂对照性临床研究中，TYVASO的最常见副作用（≥10%）为咳嗽、头痛、恶心、头晕、潮红、咽喉刺激、咽喉疼痛和腹泻。
联合治疗公司联合其子公司Lung Rx在2009年9月初将TYVASO投放至美国市场。
FDA批准治疗肺动脉高压的吸入制剂Tyvaso
United Therapeutics制药公司表示，其用于治疗肺动脉高压（PAH）的吸入剂Tyvaso已通过FDA的批准，该药通过Tyvaso吸入系统给药。这一利好消息推动该公司股票上涨了13%。
PAH是一种致命性疾病，主要特征是患者肺血管阻力进行性升高，最终可导致患者右心衰竭而死亡。
Tyvaso在这次审批过程中屡遭延期，相对于药物本身，药审官员们更关注其给药装置并对此进行了严格的审核。今年3月份，FDA就通过人体对这种装置的使用进行检测及其使用说明等提出了问题，并要求United就此开展额外的研究项目。尽管如此，分析家们对药物的前景仍然非常乐观，认为它能最终获准。
United同意在药品上市后进行售后监测工作，就Tyvaso给药系统的不足之处进行改进，对这种装置进行可用性分析，并收集药物动力学数据以检测人体对药物的反应并针对改进后的给药装置确定合适的药物剂量，这项工作将于2010年年底之前完成。
此外，该公司还同意在药品上市后进行一项长期的观察研究项目，对用药患者进行跟踪监测，评估Tyvaso毒性风险，这个项目将于2013年年底之前完成。
Tyvaso给药系统属便携式喷雾装置。Tyvaso吸入剂的活性成分为Treprostinil，与该公司出品的另一种PAH药物活性成分相同。
TYVASO（使用treprostinil）吸入
[美国治疗公司]
TYVASO（使用treprostinil）吸入溶液
最初美国批准：2002
仅口腔吸入
适应症
tyvaso是一种前列腺素扩血管治疗肺动脉高压（PAH）（WHO第1组），以提高运动能力表示。建立有效性的研究，包括与NYHA心功能III类的症状和病因特发性或结缔组织病（33％）的遗传多环芳香烃（56％）或者多环芳香烃为主的患者。
剂量和用法
只使用与Tyvaso吸入系统。
管理稀释，作为提供。一个Tyvaso单一的气息，提供约600微克的使用treprostinil。
管理中的4个独立的疗程相距约四小时，每一天，在醒着的时间。
初始剂量：[18微克每疗程3次呼吸。如果不能耐受3次呼吸，减少到1个或2个深呼吸。
剂量应增加一个额外的3次呼吸，大约每隔1-2周，如果耐受性。
滴定目标9呼吸或54微克每疗程用量为维护容忍。
剂型和优势
口腔吸入：无菌溶液2.9毫升安瓿含1.74毫克，使用treprostinil（每毫升0.6毫克）。
禁忌
无
注意事项：
安全性和有效性尚未确定，在重大基础肺疾病（如哮喘或慢性阻塞性肺病）患者。
Tyvaso在患者全身动脉血压低，可能导致症状性低血压。
tyvaso可能会增加出血的危险，尤其是在患者接受抗凝血剂。
tyvaso剂量的调整可能是必要的，如果添加或撤回CYP2C8的抑制剂或诱导。
肝或肾功能不全，可能会增加接触和减少耐受性。
不良反应
最常见的不良反应（≥10％），咳嗽，头痛，恶心，头晕，潮红，喉咙发炎，咽喉疼痛和腹泻。
药物相互作用
伴随利尿剂，抗高血压药物或其他血管扩张剂可能会增加全身性低血压的风险。
在特殊人群中使用
怀孕：Tyvaso应仅用于明确需要。
哺乳期妇女：管理哺乳妇女时，应谨慎行事。
日期：12/2011
Indication
Tyvaso is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH) (WHO Group 1), which is high blood pressure in the arteries of your lungs. Tyvaso can improve exercise ability in people who also take bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase-5 inhibitor). The effects decrease over 4 hours; treatment timing can be adjusted for planned activities.
Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
Important Safety Information for Tyvaso
•Tyvaso is breathed in (inhalable) through your mouth into your lungs. Tyvaso should only be used with the Tyvaso Inhalation System
•The effects of Tyvaso are unknown in patients with lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age
•If you have low blood pressure, Tyvaso may cause symptomatic hypotension (low blood pressure)
•Because Tyvaso reduces the ability of your blood to clot (coagulate), it may increase your risk for bleeding if you are taking blood thinners (anticoagulants), such as warfarin or heparin
•The use of Tyvaso with diuretics (water pills), antihypertensives (medications used to treat high blood pressure or heart disease), or other vasodilators (medications that lower blood pressure) may increase your risk for hypotension (low blood pressure)
Other medical conditions and medicines may affect your use of Tyvaso by increasing the risk of side effects or decreasing effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking, including:
•If you are taking gemfibrozil (for high cholesterol) or rifampin (for infection), your Tyvaso dosage may need adjustment
•If you have liver or kidney problems, your ability to tolerate Tyvaso may be affected
•If you are pregnant, breast-feeding, or planning to become pregnant, talk with your healthcare provider about whether you should take Tyvaso
The most common side effects of Tyvaso are coughing, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), and fainting or loss of consciousness. These are not all the possible side effects of Tyvaso. Tell your doctor about any side effects that bother you or do not go away. Your doctor may be able to help you manage the side effects.
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Selected Important Safety Information
In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension. The concomitant use of Tyvaso with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension
Hepatic or renal insufficiency may increase exposure to Tyvaso and decrease tolerability. Tyvaso dosage adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn
Indication
Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.
Important Safety Information for Tyvaso
Tyvaso is intended for oral inhalation only. Tyvaso is approved for use only with the Tyvaso Inhalation System
The safety and efficacy of Tyvaso have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age. Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect
Tyvaso may increase the risk of bleeding, particularly in patients receiving anticoagulants
In patients with low systemic arterial pressure, Tyvaso may cause symptomatic hypotension. The concomitant use of Tyvaso with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension
Hepatic or renal insufficiency may increase exposure to Tyvaso and decrease tolerability. Tyvaso dosage adjustments may be necessary if inhibitors of CYP2C8 such as gemfibrozil or inducers such as rifampin are added or withdrawn
The most common adverse events seen with Tyvaso in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%)
Tyvaso should be used in pregnancy only if clearly needed. Caution should be exercised when Tyvaso is administered to nursing women
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原产地英文商品名:
TYVASO INHALATION REFILL KIT 81.2AMPUL/KIT
原产地英文药品名:
TREPROSTINIL SODIUM/NEBULIZER ACCESSORIES
中文参考商品译名:
TYVASO吸入剂再填充套装 81.2安醅/套
中文参考药品译名:
曲前列尼尔钠/喷雾器附件
生产厂家中文参考译名:
联合治疗公司
生产厂家英文名:
UNITED THERAP
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原产地英文商品名:
TYVASO INHALATION STARTER KIT 81.2AMPUL/KIT
原产地英文药品名:
TREPROSTINIL SODIUM/NEBULIZER ACCESSORIES
中文参考商品译名:
TYVASO吸入剂起始套装 81.2安醅/套
中文参考药品译名:
曲前列尼尔钠/喷雾器附件
生产厂家中文参考译名:
联合治疗公司
生产厂家英文名:
UNITED THERAP
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