FDA批准治疗肺动脉高压的吸入制剂TYVASO (Treprostinil)
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。
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 Rx
Generic Name and Formulations:
Treprostinil 0.6mg/mL; soln for oral inhalation using Tyvaso Inhalation System.

Company:
United Therapeutics Corp.
Indications for TYVASO:
Pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms, to improve exercise ability.

Adult:
Give 4 separate treatment sessions each day approximately 4hrs apart, during waking hours. ≥18yrs: Initially 3 breaths (18mcg) per treatment session; if not tolerated, reduce to 1–2 breaths, and then subsequently increase to 3 breaths as tolerated. Maintenance: may increase by an additional 3 breaths at 1–2 week intervals, if tolerated, to target dose of 9 breaths (54mcg) per treatment session.

Children:
<18yrs: not established.

Pharmacological Class:
Prostacyclin analogue.

Warnings/Precautions:
Significant underlying lung disease (eg, asthma, COPD). Acute pulmonary infections. Patients with low systemic arterial pressure. Hepatic or renal insufficiency. Bleeding disorders. Avoid contact with eyes and skin, oral ingestion. Elderly. Labor & delivery. Pregnancy (Cat.B). Nursing mothers.

Interactions:
Increased risk of symptomatic hypotension with concomitant diuretics, antihypertensives, other vasodilators. May be potentiated by CYP2C8 inhibitor (eg, gemfibrozil). May be antagonized by CYP2C8 inducer (eg, rifampin). Increased risk of bleeding with anticoagulants.

Adverse Reactions:
Cough, headache, nausea, diarrhea, dizziness, flushing, throat irritation, pharyngolaryngeal pain; symptomatic hypotension, bleeding.

How Supplied:
Ampules (2.9mL)—4
Starter Kit—1 (28 ampules with inhalation system)
Refill Kit—1 (28 ampules with accessories)