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英文药名: Isentress(Raltegravir Tablets) 中文药名: 整合酶抑制剂 雷特格韦钾片剂 艾生特 品牌药生产厂家: Merck Frosst 药品介绍 Isentress (雷特格韦) 片剂是默沙东公司 (MSD) 生产的一种整合酶抑制剂，2011年12月21日，美国食品药品管理局(FDA)宣布Isentress获准与其他抗逆转录病毒药物联合用于治疗2~18岁、感染1型人类免疫缺陷病毒(HIV-1)的儿童和青少年。据认为，Isentress是一种整合酶链转移反应抑制剂，曾在2007年获准用于治疗成人感染者。 一项多中心的单项临床试验对Isentress的安全性和有效性进行了评估，其受试者为96例2~18岁、感染HIV-1的儿童和青少年，这些患者之前曾接受过抗HIV-1感染治疗。该研究结果显示，经过24周的Isentress治疗后，53%的患者血中HIV量达到检测不到的水平。 服用Isentress的患者最常报告的严重的治疗相关性不良反应包括失眠和头痛，这些不良反应的发作次数在儿童与成人中相近。1例患儿报告出现严重的治疗相关性失眠，还有1例出现药物相关性皮疹，发生这种情况时，应停用Isentress。 Isentress是一种片剂，每日服用2次，与餐同服或不同服均可。另外，该药也有相应的咀嚼片出售。由于这两种片剂不可换用，故咀嚼片仅批准用于2~11岁的儿童. 商品名：整合酶抑制剂 Isentress的raltegravir钾片剂，薄膜包衣 初步U. S.批准：2007年 最近的重大变化 适应症和用法 适应症 Isentress的是人类免疫缺陷病毒整合酶链转移酶抑制剂（HIV - 1 INSTI）表示： 与其他抗逆转录病毒药物治疗的HIV - 1感染成年患者相结合。 剂量和用法 口服，每日两次，带或不带食品的400毫克。 在合用利福平，800毫克，每天两次。 剂型和优势 片剂：400毫克。 禁忌 无。 警告和注意事项 监测免疫重建综合症。 不良反应 最常见的不良反应的中度至重度（≥2％）发生率较高，比比较，失眠和头痛。 肌酸激酶升高，观察收到Isentress的科目。肌病和横纹肌溶解症的报道。使用肌病或横纹肌溶解症的风险增加，如病人接受已知会导致这些条件的合并用药，患者慎用。 药物相互作用 Isentress的强烈诱导UGT1A1与药物合用可能导致血药浓度降低raltegravir。 在特殊人群中使用 怀孕： Isentress的，应在怀孕期间使用，只有当潜在的好处，证明对胎儿的潜在危险。医生们踊跃报名暴露致电1-800-258-4263，使默沙东公司，默克制药公司，公司的子公司，可以监测产妇和胎儿的结果的Isentress的孕妇。 哺乳母亲： 哺乳不建议同时服用Isentress的。 更新日期：02/2011 Merck & Co Inc (Whitehouse Station, NJ) Indication: Merck & Co Inc announced that the FDA approved an additional indication for Isentress (raltegravir). The expanded indication now includes use in the treatment of adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as in treatmentexperienced adult patients. It is used in combination with other antiretroviral medicines for the treatment of HIV-1 infection in adult patients. Dosage Form: Tablets: 400 mg brand name: Isentress but most common are diarrhea, nausea, headache, and fever. Less common are abdominal pain, vomiting, fatigue, weakness, dizziness, and lipodystrophy. Other observations with unclear relationship to Isentress include cancer (new and recurrent, though most patients had other risk factors for cancer), low white blood cell count (neutropenia), low platelets, and elevated liver enzyme levels. May cause elevated levels of a muscle enzyme (creatine kinase) on blood tests. Contact your health care provider if you experience unexplained muscle pain, tenderness, or weakness. May cause hypersensitivity (allergic reaction), anemia, neutropenia, and gastritis. Increases in ALT, AST, and total bilirubin, all signs of liver toxicity, seen in around 8% of people taking Isentress. Increases were more likely in people also infected with hepatitis B or C. Immune Reconstitution Inflammatory Syndrome (IRIS) may occur as the immune system regains strength; signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is initiated. Report symptoms of illness, such as shingles and TB, to a health care provider. Potential drug interactions Aptivus/Norvir can decrease the concentrations of Isentress, but no clinically significant interaction was observed from the clinical studies in patients receiving both drugs. Dose adjustment is not required. Reyataz and Reyataz/Norvir increase blood levels of Isentress, but no dose adjustment is recommended. Use caution with rifampin, which reduces plasma concentrations of Isentress; increase dose of Isentress to 800 mg twice a day. Prilosec (omeprazole) can increase concentrations of Isentress, but no dose adjustment is recommended. There is no interaction with methadone. Isentress (Raltegravir) Package Insert Updated From U.S. Food and Drug Administration November 3, 2011 Updates to the Isentress (raltegravir) package insert were approved on November 2, 2011 to include a new subsection in the Warnings and Precautions section and update the postmaketing experience section. Specifically, the following subsection was added to section 5 Warnings and Precautions: Severe Skin and Hypersensitivity Reactions Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure. Discontinue ISENTRESS and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping ISENTRESS treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.
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