药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(2011122823442315.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Makena处方资料(仅供参考)
Makena获准用于预防早产 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 is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered < 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Important Safety Information Makena should not be used in women with any of the following conditions: •Current or history of thrombosis or thromboembolic disorders •Known or suspected breast cancer, other hormone-sensitive cancer or history of these conditions •Undiagnosed abnormal vaginal bleeding unrelated to pregnancy •Cholestatic jaundice of pregnancy •Liver tumors, benign or malignant, or active liver disease •Uncontrolled hypertension Makena should be discontinued if thrombosis or thromboembolism occurs.
Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of Makena or with other products containing castor oil.
Women receiving Makena should be monitored if they: •Are prediabetic or diabetic •Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction •Have a history of clinical depression; Makena should be discontinued if depression recurs •Develop jaundice; consider whether benefit of use warrants continuation •Develop hypertension
Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%).
The most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions (pain [35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]), urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea (2% vs. 1%).
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(2011122823442315.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |