---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（200971300280710.pdf）的“原文Priscribing Information”为准
---------------------------------------------------------------

 部分中文德泊噻处方资料（仅供参考）

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.As a result, treatment with DEPOCYT is well distributed throughout the CSF and offers prolonged exposure of the tumor cells to cytarabine.Because DEPOCYT is a sustained release formulation, it provides convenient dosing of every two weeks as compared to twice weekly with unencapsulated cytarabine.

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  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. 

-------------------------------------------------------