新型诊断药物Macrilen(macimorelin)-用于生长激素缺乏症诊断. 近日,美国FDA批准其口服生长素释放肽激动剂Macrilen(macimorelin),用于成年生长激素缺乏症(AGHD)患者的诊断,这也是美国FDA药品评估和研究中心(CDER)今年批准的第44个新药分子。 批准日期:2017年12月25日 公司:Aeterna Zentaris公司 MACRILEN(macimorelin)为口服溶液 美国初次批准:2017 作用机制 Macimorelin通过活化存在与垂体和下视丘的生长激素促分泌素受体刺激稀释GH释放。 适应证和用途 MACRILEN是一种生长激素(GH)促分泌素受体激动剂适用为成年生长激素缺乏的诊断。 使用的限制:尚未曽确定对受试者有BMI>40kg/m2的安全性和诊断性能。 剂量和给药方法 ● 推荐剂量是0.5mg/kg作为一个单次口服剂量,空腹后共至少8小时。 ● 见完整处方资料对重要制备和给药指导. ● 终止治疗用强CYP3A4诱导剂,MACRILEN给药前生长激素和影响GH释放药物共一个适当长度时间。 ● 给予MACRILEN前适当地替代其他激素缺乏。 剂型和规格 为口服溶液:60mg 禁忌证 无。 警告和注意事项 ● 心室性心动过速. 避免MACRILEN与已知延长OT间期药物同时使用. ● 使用强CYP3A4诱导剂可能导致假阳性结果:测试前终止和冲洗强CYP3A4诱导剂。 ●近期发作性下丘脑疾病的假阴性检测结果的可能性:如有适应证重复测试。 不良反应 最常见不良反应为味觉障碍,眩晕,头痛,疲乏,恶心,饥饿,腹泻,上呼吸道感染,感觉热,多汗症,鼻咽炎,和窦性心动过缓。 如何供应/贮存和处置 MACRILEN 60 mg被供应为白色至米色颗粒在一个铝袋中。每袋含60mg macimorelin(等同于68 mg macimorelin醋酸盐)当用120mL的水重建提供一个60mg/120mL(0.5mg/mL)macimorelin溶液。 可得到在盒中MACRILEN含每盒1袋(NDC 58844-130-01)。 为口服溶液MACRILEN给药前必须由一位卫生保健专业人员重建[见剂量和给药方法(2.3)]。在冰箱在2-8°C(36-46°F)贮存袋。 溶液必须在制备后30分钟内使用。遗弃未使用部分。 完整说明书附件:https://www.strongbridgebio.com/wp-content/uploads/macrilen-prescribing-information.pdf MACRILEN(macimorelin)for oral solution Indication Macrilen is indicated for the diagnosis of adult growth hormone deficiency (AGHD). Limitations of Use The safety and diagnostic performance of Macrilen have not been established for subjects with a body mass index (BMI) > 40 kg/m2. Important Safety Information Warnings and Precautions QT Prolongation Macrilen causes an increase of about 11 msec in the corrected QT (QTc) interval. QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. The concomitant use of Macrilen with drugs that are known to prolong the QT interval should be avoided. Potential for False Positive Test Results with Use of Strong CYP3A4 Inducers Concomitant use of strong CYP3A4 inducers with Macrilen can decrease macimorelin plasma levels significantly and thereby lead to a false positive result. Strong CYP3A4 inducers should be discontinued and enough time should be given to allow washout of CYP3A4 inducers prior to test administration. Potential for False Negative Test Results in Recent Onset Hypothalamic Disease Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process. Macimorelin acts downstream from the hypothalamus and macimorelin stimulated release of stored GH reserves from the anterior pituitary could produce a false negative result early when the lesion involves the hypothalamus. Repeat testing may be warranted in this situation. Adverse Reactions The most common adverse reactions were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia |
MACRILEN(macimorelin for oral solution)简介:新型诊断药物Macrilen(macimorelin)-用于生长激素缺乏症诊断.近日,美国FDA批准其口服生长素释放肽激动剂Macrilen(macimorelin),用于成年生长激素缺乏症(AGHD)患者的诊断,这也是美国FDA药品评估和 ... 责任编辑:p53
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