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FDA批准曲前列尼尔缓释片治疗肺动脉高压
2013年12月20日美国FDA批准Orenitram（曲前列尼尔，treprostinil Extended-Release Tablets）缓释片用于治疗肺动脉高压（PAH ）在WHO I组患者，提高他们的运动能力。
此前FDA从未批准过一种口服前列环素类似物用于疗何疾病的治疗，并且这是FDA批准的第5个PAH药物，以为医师和患者提供比较广泛的治疗选择。
一项主要名为“FREEDOM-M”的疗效研究建立了效果证据，包括有WHO功能II-III级症状和特发性或遗传性PAH（75％）或结缔组织病（19％）相关PAH病因的患者。研究显示：接受Orenitram每日两次的患者6分钟行走距离（6MWD）比安慰剂组患者增加23米（中位数）[p=0.013]。然而，另外两项III期临床研究（FREEDOM-C和FREEDOM-C2）并没有显示出它在第16周对运动能力（6MWD）中位数有益（分别为11米[p=0.072]和10米[P=0.089]）。
在临床研究中报告的Orenitram最常见（经安慰剂校正后发生率>10％）副作用为头痛、恶心和腹泻。
Orenitram每天给药两次，与食物一起服用，但每日总剂量也可以分成三次。 Orenitram有四种剂量规格：0.125毫克，0.25毫克，1毫克和2.5毫克。当患者耐受时，Orenitram的剂量可以适当增加，以达到最佳临床应答。最大剂量是应根据耐受性来确定。
Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs. Orenitram may improve your ability to exercise. It is not known if Orenitram is safe and effective in children under 18 years of age.
ORENITRAM Rx
Generic Name and Formulations:
Treprostinil 0.125mg, 0.25mg, 1mg, 2.5mg; ext-rel osmotic tabs.
Company:
United Therapeutics Corp.
Indications for ORENITRAM:
Pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to improve exercise capacity.
Adult Dose for ORENITRAM:
Take with food. Swallow whole. Individualize. Initially 0.25mg twice daily (~12hrs apart); may increase in increments of 0.25mg or 0.5mg twice daily every 3–4 days; if not tolerated, consider titrating slower. The total daily dose can be divided and given approx. 8 hrs apart, titrating by increments of 0.125mg three times daily. If intolerable adverse effects occur, decrease in 0.25mg increments. Mild hepatic impairment (Child Pugh Class A) or concomitant strong CYP2C8 inhibitors (eg, gemfibrozil): initially 0.125mg twice daily; titrate by increments of 0.125mg twice daily every 3–4 days. Moderate hepatic impairment (Child Pugh Class B): not recommended. Treatment interruption or discontinuation: see full labeling.
Children's Dose for ORENITRAM:
Not established.
Pharmacological Class:
Prostacyclin analogue.
Contraindications:
Severe hepatic impairment (Child Pugh Class C).
Warnings/Precautions:
Avoid abrupt withdrawal or sudden large dose reduction (see full labeling). Increased risk of bleeding. Hepatic impairment. Diverticulosis or blind-end pouches. Elderly. Labor & delivery. Pregnancy (Cat. C). Nursing mothers: not recommended.
Interactions:
Avoid alcohol. Increased risk of symptomatic hypotension with concomitant diuretics, antihypertensives, or other vasodilators. Increased risk of bleeding with anticoagulants. Potentiated by CYP2C8 inhibitors (eg, gemfibrozil).
Adverse Reactions:
Headache, nausea, diarrhea, flushing, pain in extremity, jaw pain, hypokalemia, abdominal discomfort.
How Supplied:
Ext-rel tabs—100
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产地国家: 美国
原产地英文商品名:
ORENITRAM ER 0.125mg 100tabs
原产地英文药品名:
TREPROSTINIL DIOLAMINE
中文参考商品译名:
ORENITRAM缓释片 0.125毫克/片 100片/盒
中文参考药品译名:
曲前列尼尔
生产厂家英文名:
UNITED THERAP
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产地国家: 美国
原产地英文商品名:
ORENITRAM ER 0.25mg 100tabs
原产地英文药品名:
TREPROSTINIL DIOLAMINE
中文参考商品译名:
ORENITRAM缓释片 0.25毫克/片 100片/盒
中文参考药品译名:
曲前列尼尔
生产厂家英文名:
UNITED THERAP
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产地国家: 美国
原产地英文商品名:
ORENITRAM ER 1mg 100tabs
原产地英文药品名:
TREPROSTINIL DIOLAMINE
中文参考商品译名:
ORENITRAM缓释片 1毫克/片 100片/盒
中文参考药品译名:
曲前列尼尔
生产厂家英文名:
UNITED THERAP
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产地国家: 美国
原产地英文商品名:
ORENITRAM ER 2.5mg 100tabs
原产地英文药品名:
TREPROSTINIL DIOLAMINE
中文参考商品译名:
ORENITRAM缓释片 2.5毫克/片 100片/盒
中文参考药品译名:
曲前列尼尔
生产厂家英文名:
UNITED THERAP | 
