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己酸羟孕酮注射液|Makena(hydroxyprogesterone caproate)

2011-04-20 15:13:06  作者:新特药房  来源:中国新特药网天津分站  浏览次数:257  文字大小:【】【】【
简介: 制造商: 热敏- Rx的公司 药理分类: 孕激素。 活性成分(补): 羟基己酸250mg/mL;深的IM损伤;含有蓖麻油,苯甲酸苄酯,苯甲醇。 指示(补): 为了减少与一个单胎妊娠的妇女谁拥有单身自发早产史的早 ...

制造商:
热敏- Rx的公司

药理分类:
孕激素。

活性成分(补):
羟基己酸250mg/mL;深的IM损伤;含有蓖麻油,苯甲酸苄酯,苯甲醇。
指示(补):
为了减少与一个单胎妊娠的妇女谁拥有单身自发早产史的早产风险。不适合在多胞胎早产或其他危险因素的患者使用。

药理作用:
羟基是一种合成的孕激素是表示要减少在怀孕后16周在某些易感病人早产的危险。

肌肉注射后,羟基己酸在大约3-7天到达高峰水平。这是高度与血浆蛋白结合,并广泛在肝脏代谢几个代谢途径。双方共轭类固醇代谢物和自由通过消除尿和粪便的路线。


临床试验:
一个多中心,随机,双盲,车辆控制的试验,涉及463名孕妇进行了评估减少自发早产风险的安全性和羟基己酸的疗效。该研究纳入女性16至43岁的单身人士自发与早产16周之间的历史谁0天,20周6天,一个单胎妊娠的妊娠。在随机分派时,用超声检查,以确认妊娠年龄和任何已知的胎儿异常的情况下。与以前的孕激素治疗或使用肝素妇女被排除在外,因为是用血栓性疾病或产妇/产科并发症史者。

与汽车相比,控制,羟基己酸减少了妇女的比例谁送来的<37周(-17.8%),早产待遇。妇女的比例谁在<35周和“<32周交货也给予研究药物在(-9.4%和-7.7%,分别)的组。有没有整体的生存优势与研究药物由于死胎和流产率较高的待遇;研究仍在继续。


法律分类:
接收

成人:
开始治疗16周0天至20周6天妊娠。慢慢注入(超过1分钟或更长时间)到高端的臀大肌外侧象限。 250毫克的IM每周一次。继续,直到第37周(至36周,6天)怀孕或分娩,以先到者为准。

儿童:
不适用。

禁忌(补):
电流或血栓形成或栓塞病史。乳腺癌或其他激素敏感的癌症。未确诊的异常生殖器出血。妊娠胆汁淤积性黄疸。肝腺瘤或癌。不受控制的高血压。


警告/注意事项:
由体液潴留(例如,先兆子痫,偏头痛,哮喘,癫痫,心脏或肾功能障碍)加重条件。监测糖尿病和抑郁症。肝功能不全。如果停止抑郁,血栓性事件或发生过敏反应。重新评价如果出现黄疸或高血压。为制止不积极早产使用。妊娠(部件乙)(于第一孕期利用有限的数据)。哺乳母亲:不推荐;之后停止交付。

互动(补):
由CYP1A2的可能影响,CYP2A6,CYP2B6或(如茶碱,替扎尼定,氯氮平,尼古丁,乙酰氨基酚,依非韦伦,安非他酮,美沙酮)代谢的药物代谢的影响。

不良反应(补):
注射液部位反应(疼痛,肿胀,瘙痒,结节),荨麻疹,瘙痒,胃肠不适,怀孕有关的胎儿和孕妇的并发症。


如何提供:
多剂量小瓶(5毫升)-1


美国FDA批准一种预防早产药物-Makena(hydroxyprogesterone caproate)
2011年2月4日,美国食品药品管理局FDA和K-V制药公司宣布,Makena己酸羟孕酮注射剂已获准用于有≥1次自发性早产史的孕妇以降低早产风险。该药不适用于多胎妊娠如双胎妊娠或有其他早产危险因素的女性。
FDA审查了一项多中心、随机、双盲临床试验中Makena的安全性和疗效数据。这项研究纳入了463名年龄介于16~43岁、既往有1次自发性早产史的单胎妊娠女性。结果显示,Makena治疗组有37%的女性于37孕周之前分娩,而对照组有55%。

在另一项研究中,研究者对参加对照试验的母亲所生孩子的发育情况进行了评估。结果证实,无论其母亲在随机试验中接受了何种疗法,所有孩子在年龄2.5~5岁时均达到了同一发育目标。目前有一项验证性研究正在进行中,之后会针对婴儿开展一项相似的随访研究,大概在2018年完成,该研究预计将纳入580~750名婴儿。
Makena的最常见不良反应包括注射部位疼痛、肿胀或瘙痒,以及荨麻疹、恶心和腹泻。严重不良反应少见。

Makena禁用于有以下任何一种情况的女性:当前或既往曾患有血栓症或血栓栓塞性疾病;已知患有乳腺癌或疑似乳腺癌,其他激素敏感性癌症,或有这些癌症的病史;未经诊断的与妊娠无关的异常阴道流血;妊娠期胆汁淤积性黄疸;肝脏良、恶性肿瘤或活动性肝病;高血压控制不良。

Makena由医护人员给药,于16~20孕周开始,每周肌注1次,一直持续至37孕周结束或至分娩以先发生者为准。

根据能够合理预测临床收益的替代终点收益在本批准令中是指降低在37孕周前分娩的风险,FDA基于加速审批法规批准了Makena这一具有应用前景的药物。根据上述法规,生产厂家必须在产品获批后开展进一步研究以证实其确实能产生临床收益。

FDA最初于1956年批准商品名为Delalutin的己酸羟孕酮用于孕妇,获准的适应证包括先兆流产。2000年,原生产厂家申请Delalutin撤市,撤市原因与安全性无关。

MAKENA

Manufacturer:

Ther-Rx Corporation

Pharmacological Class:

Progestin.

Active Ingredient(s):

Hydroxyprogesterone caproate 250mg/mL; for deep IM inj; contains castor oil, benzyl benzoate, benzyl alcohol.

Indication(s):

To reduce risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Not intended for use in patients with multiple gestations or other risk factors for preterm birth.

Pharmacology:

Hydroxyprogesterone is a synthetic progestin that is indicated to reduce the risk of preterm delivery in certain susceptible patients after the 16th week of pregnancy.

After IM administration, hydroxyprogesterone caproate reaches peak levels in about 3–7 days. It is highly bound to plasma proteins and is extensively metabolized in the liver by several metabolic pathways. Both conjugated metabolites and free steroids are eliminated via urinary and fecal routes.

Clinical Trials:

A multicenter, randomized, double-blind, vehicle-controlled trial involving 463 pregnant women was conducted to assess the safety and efficacy of hydroxyprogesterone caproate in reducing the risk of spontaneous preterm birth. The study enrolled women 16 to 43 years of age with a history of singleton spontaneous preterm birth who were between 16 weeks 0 days and 20 weeks 6 days gestation with a singleton pregnancy. At the time of randomization, ultrasound was used to confirm gestational age and the absence of any known fetal abnormality. Women with prior progesterone treatment or heparin use were excluded, as were those with a history of thrombotic disease or maternal/obstetrical complications.

Compared to treatment with the vehicle control, treatment with hydroxyprogesterone caproate reduced the proportion of women who delivered preterm at <37 weeks (–17.8%). The proportions of women who delivered at <35 weeks and <32 weeks were also lower in the group given the study drug (–9.4% and –7.7%, respectively). There was no overall survival advantage to treatment with the study drug due to a higher rate of stillbirth and miscarriage; studies are continuing.

Legal Classification:

Rx

Adults:

Begin treatment between 16 weeks 0 days and 20 weeks 6 days gestation. Inject slowly (over 1 minute or longer) into upper outer quadrant of gluteus maximus. 250mg IM once weekly. Continue until Week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever comes first.

Children:

Not applicable.

Contraindication(s):

Current or history of thrombosis or thromboembolic disorders. Breast or other hormone-sensitive cancers. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy. Hepatic adenoma or carcinoma. Uncontrolled hypertension.

Warnings/Precautions:

Conditions aggravated by fluid retention (eg, preeclampsia, migraine, asthma, seizures, cardiac or renal dysfunction). Monitor diabetics and for depression. Hepatic impairment. Discontinue if depression, thromboembolic events or allergic reactions occur. Reevaluate if jaundice or hypertension occurs. Not for use in stopping active preterm labor. Pregnancy (Cat. B) (limited data on 1st trimester use). Nursing mothers: not recommended; discontinue upon delivery.

Interaction(s):

May affect metabolism of drugs metabolized by CYP1A2, CYP2A6, or CYP2B6 (eg, theophylline, tizanidine, clozapine, nicotine, acetaminophen, efavirenz, bupropion, methadone).

Adverse Reaction(s):

Inj site reactions (pain, swelling, pruritus, nodule), urticaria, pruritus, GI upset; pregnancy-related fetal and maternal complications.

How Supplied:

Multidose vial (5mL)—1

Last Updated:

4/14/2011

责任编辑:admin


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