VELETRI(EPOPROSTENOL SODIUM)INJECTABLE INJECTION为第二代肺动脉高血压注射剂，获得美国食品药监局(FDA)批准，用于治疗肺动脉高血压(PAH),能够改善运动能力.
批准日期：2012年7月 公司：Actelion公司美国制药公司
VELETRI（依前列醇 epoprostenol）注射  供注射使用
最初美国批准：1995年
目前的主要变化
作用机理
依前列醇具有2个主要的药理作用：（1）肺部和全身动脉血管床的直接血管扩张，和血小板聚集的（2）抑制
用法与用量 06/2012
适应症和用法
VELETRI为肺动脉高压（PAH）（世界卫生组织组1）的处理，以改善运动能力指示的前列腺素的血管扩张剂。研究建立主要功效包括患者的心功能III-IV级的症状和结缔组织疾病相关的特发性或遗传性PAH或PAH的病因。
用法用量
剂量
- VELETRI输注应在2毫微克/公斤/分钟开始，并在2毫微克/公斤/分钟的增量增加，每15分钟或更长时间，直到剂量限制性药理作用被激发，或直到一个公差极限的药物被建立。
- 如果肺动脉高压症状持续或改善后复发 - 输注应增加1到2纳克/千克/分钟的增量在足以间隔以允许临床反应的评估;这些间隔应该是至少15分钟。
行政
- VELETRI通过连续静脉内输液经由使用移动式输注泵的中央静脉导管施用。
- 不要用之前或期间给予任何其他胃肠道药物或解决方案混合。
重建
- 重构小瓶只有5毫升或无菌注射用水或0.9％氯化钠注射液。
- VELETRI溶液重构，并立即稀释至药物递送贮存器中的最终浓度可以根据使用的条件来施用，如表1中概述。
- 对于慢性递送解决方案应该在一个药物递送贮存器适合于输液泵来制备。
剂型和规格
10毫升小瓶0.5毫克（500,000 NG）或1.5毫克（150万纳克）VELETRI。
禁忌症
充血性心脏衰竭，由于严重的左心室收缩功能不全
肺水肿
过敏药物或结构相关化合物
警告和注意事项
VELETRI应仅由在肺动脉高压的诊断和治疗有经验的临床医生可以使用。
指示，用注射用无菌水或0.9％氯化钠注射液仅重建。
不要突然降低剂量或给药退出。所有配料启动和变化应密切监测。
不良反应
在最常见的不良反应：
- 剂量启动和升级：恶心，呕吐，头痛，低血压，面色潮红，胸痛，焦虑，头晕，心动过缓，呼吸困难，腹痛，肌肉骨骼疼痛和心动过速
- 长期给药：头痛，下巴疼痛，潮红，腹泻，恶心，呕吐，流感样症状和焦虑/紧张。
包装规格/储存与处理
关于如何供给VELETRI如在10mL小瓶中的无菌冻干材料供给。
10毫升小瓶含依前列醇钠当量0.5毫克（500,000 NG）依前列醇白色翻盖关闭密封，包装在1瓶箱（NDC66215-403-01）。
10毫升小瓶含依前列醇钠当量1.5毫克（150万纳克）依前列醇红色翻盖关闭密封，包装在1瓶箱（NDC66215-402-01）。
存储VELETRI的小瓶在68°至77°F（20°至25°C）[见USP控制室温。
直到日期（20°至25°C）时，保存在68°至77°F包装上标明VELETRI的储存及稳定性未开封的药瓶是稳定的。未开封的小瓶应当保存在纸箱中，并没有暴露在阳光直射。

Actelion Ltd announced that the U.S. Food and Drug Administration (FDA) has approved additional in-use conditions for administration of Veletri, an improved formulation of epoprostenol. The additional product information allows patients with moderate to severe pulmonary arterial hypertension (PAH) and PAH associated with the scleroderma spectrum of disease who do not respond adequately to conventional therapy that use Veletri to prepare their medication up to seven days in advance (for concentrations of >9,000 to 30,000 ng/ml) and store filled cassettes refrigerated at 2°C to 8°C (36° to 46°F). Patients also have the option to administer Veletri at room temperature immediately after dilution for up to 48 hours at concentrations ?30,000 ng/mL. Veletri is the first and only intravenous prostacyclin for PAH that offers the flexibility of different preparation and storage options prior to administration.
Dr. Vallerie McLaughlin, Professor of Medicine and Director of Pulmonary Hypertension at the University of Michigan, commented: “Patients with more advanced PAH struggle daily with debilitating symptoms, such as shortness of breath, chest pain and chronic fatigue. I expect the improved convenience of Veletri's preparation and storage flexibility to significantly benefit these patients and make a difference in their everyday life.”
In conjunction with the launch of Veletri, which has been commercially available in the United States since April 2010, Actelion opened its fourth U.S. PAH patient registry.  PROSPECT, the registry to PROSPECTively evaluate use of Veletri in patients with PAH, is a multicenter, observational, U.S.-based registry and is currently registering patients.
Shal Jacobovitz, President of Actelion Pharmaceuticals US, Inc. commented: “Actelion has further characterized the stability of Veletri and followed through with the regulatory procedures resulting in this updated label. This allows physicians and patients in the U.S. to fully utilize the advantages offered by Veletri’s stability profile.”
Actelion will provide further information on Veletri at the American Heart Association Scientific Sessions 2010 in Chicago with a poster entitled “Biocomparability of Two Formulations of Epoprostenol, Epoprostenol for Injection (ACT-385781A) and Flolan, Via Pharmacokinetic Assessment Of Two Primary Metabolites.”
The U.S. FDA approved the brand name Veletri for the company's epoprostenol for injection therapy in August 2010. Consequently, Veletri labeled product will be available in the fourth quarter of 2010. The registration process for Epoprostenol for Injection is ongoing outside the U.S., initially in France, also with Veletri as the proposed brand name.
http://www.druglib.com/druginfo/veletri/indications_dosage/
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df502787-46ec-4dd1-a2c0-be90f6d95a5d