DEPOCYT is a sustained release formulation of cytarabine approved for the treatment of lymphomatous meningitis. The unique liposomal encapsulation of DEPOCYT is designed to release cytarabine into the cerebrospinal fluid over an extended period of time: DEPOCYT has a half-life of up to 82.4 hours, compared to 3.4 hours for unencapsulated cytarabine.1, 2 As a result, treatment with DEPOCYT is well distributed throughout the CSF and offers prolonged exposure of the tumor cells to cytarabine.3 Because DEPOCYT is a sustained release formulation, it provides convenient dosing of every two weeks as compared to twice weekly with unencapsulated cytarabine.1 Two randomized, multi-center clinical trials of DEPOCYT in patients with neoplastic meningitis (n=223) were conducted; 57 patients had lymphomatous meningitis. Patients were treated intrathecally with either with 50mg of DEPOCYT every two weeks or unencapsulated cytarabine twice weekly. In Study 1, DEPOCYT achieved a complete response rate of 41% compared with only 6% for unencapsulated cytarabine. In Study 2 lymphomatous meningitis subset analysis, DEPOCYT achieved a complete response rate of 33% compared with 17% for unencapsulated cytarabine. Complete response was prospectively defined as both (i) conversion of positive to negative CSF cytology and (ii) the absence of neurologic progression. In the controlled clinical trials, the most common severe adverse event was chemical arachnoiditis. Other reported adverse events included headache, nausea, and vomiting; these adverse events are manageable and are consistent with those commonly seen with intrathecal chemotherapy. Dexamethasone should be concomitantly administered with DEPOCYT® (cytarabine liposome injection) to reduce the risk and severity of chemical arachnoiditis. Cytarabine, the active component of DEPOCYT, can cause fetal harm if a pregnant woman is exposed to the drug systemically. However, the concern for fetal harm following intrathecal DEPOCYT administration is low because systemic exposure to cytarabine is negligible. Despite the low apparent risk for fetal harm, women of childbearing potential should be advised to avoid becoming pregnant. DEPOCYT is contraindicated in patients who are hypersensitive to cytarabine or any component of the formulation, and in patients with active meningeal infection. 德泊噻 阿糖胞嘧啶说明书 [-产地国家-] 美国 近日,FDA正式批准了阿糖胞苷注射剂(cytarabine liposome injection,DepoCyt),用于治疗一种致命性的淋巴瘤综合征——肿瘤性脑膜炎。此前,DepoCyt获得了FDA的快速批准资格。 DepoCyt是一种缓释的化学治疗药物。阿糖胞苷可以控制淋巴瘤性脑膜炎,但是由于其半衰期较短,每周需要进行2次脊椎穿刺,而DepoCyt仅需2周使用1次。DepoCyt可以将阿糖胞苷缓慢的释放进入脑脊髓液,因此可以显著的增加其半衰期,延长作用时间,而且其分布也更加均匀。只有进行过膜内肿瘤化学治疗药物操作的有资格的医师才可以使用DepoCyt。在所有的临床试验中最常见的不良反应为化学性蛛网膜炎,该不良反应的最初症状为恶心、呕吐、头痛已经发烧。如果不采取治疗措施,化学性蛛网膜炎有致命的危险。同时服用地塞米松可以减少该不良反应的发生率和严重程度。因此使用DepoCyt治疗的患者应同时使用地塞米松,以缓和化学性蛛网膜炎的症状。 |
阿糖胞苷注射剂(德泊噻DepoCyt)简介:
DEPOCYT is a sustained release formulation of cytarabine approved for the treatment of lymphomatous meningitis. The unique liposomal encapsulation of DEPOCYT is designed to release cytara ... 责任编辑:admin |
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