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Depocyt (Cytarabine) - Summary

 
 



WARNING

DepoCyt® (cytarabine liposome injection) should be administered only under the supervision of a qualified physician experienced in the use of intrathecal cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. In all clinical studies, chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event. If left untreated, chemical arachnoiditis may be fatal. The incidence and severity of chemical arachnoiditis can be reduced by coadministration of dexamethasone (see WARNINGS). Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis (see DOSAGE AND ADMINISTRATION).

 

DEPOCYT SUMMARY

RX ONLY
DEPOCYT®
(cytarabine liposome injection)
For Intrathecal Use Only
50 mg vial

DepoCyt® (cytarabine liposome injection) is a sterile, injectable suspension of the antimetabolite cytarabine, encapsulated into multivesicular lipid-based particles.

DepoCyt® (cytarabine liposome injection) is indicated for the intrathecal treatment of lymphomatous meningitis. This indication is based on demonstration of increased complete response rate compared to unencapsulated cytarabine. There are no controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms, or increased time to disease progression, or increases survival.


See all Depocyt indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Depocyt (Cytarabine)

Viral Meningitis: An Overview
Source: Medscape Pharmacists Headlines [2014.09.17]
What distinguishes viral meningitis from bacterial meningitis?
U.S. Pharmacist

2 Vaccines Help Cut Bacteria That Cause Meningitis, Study Finds
Source: MedicineNet Encephalitis and Meningitis Specialty [2014.08.20]
Title: 2 Vaccines Help Cut Bacteria That Cause Meningitis, Study Finds
Category: Health News
Created: 8/19/2014 12:35:00 PM
Last Editorial Review: 8/20/2014 12:00:00 AM

Meningitis
Source: MedicineNet Bioterrorism Specialty [2014.08.04]
Title: Meningitis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/4/2014 12:00:00 AM

Doctors Urge Meningitis Shots for Vulnerable Infants, Children
Source: MedicineNet Encephalitis and Meningitis Specialty [2014.07.28]
Title: Doctors Urge Meningitis Shots for Vulnerable Infants, Children
Category: Health News
Created: 7/28/2014 9:35:00 AM
Last Editorial Review: 7/28/2014 12:00:00 AM

Anti-Inflammatory Helps Treat Bacterial Meningitis: Study
Source: MedicineNet dexamethasone oral Specialty [2010.09.30]
Title: Anti-Inflammatory Helps Treat Bacterial Meningitis: Study
Category: Health News
Created: 9/29/2010 6:10:00 PM
Last Editorial Review: 9/30/2010

more news >>

Published Studies Related to Depocyt (Cytarabine)

Comparison of high-dose cytarabine and timed-sequential chemotherapy as consolidation for younger adults with AML in first remission: the ALFA-9802 study. [2011.08.18]
To assess the value of administering timed-sequential chemotherapy (TSC; 2 therapeutic sequences separated by a 4-day interval-free chemotherapy) or high-dose cytarabine (HDAraC) cycles in consolidation therapy for acute myeloid leukemia (AML), 459 patients 15 to 50 years of age were enrolled in the prospective randomized Acute Leukemia French Association-9802 trial...

Cytarabine dose of 36 g/m(2) compared with 12 g/m(2) within first consolidation in acute myeloid leukemia: results of patients enrolled onto the prospective randomized AML96 study. [2011.07.01]
PURPOSE: To assess the optimal cumulative dose of cytarabine for treatment of young adults with acute myeloid leukemia (AML) within a prospective multicenter treatment trial... CONCLUSION: In young adults with AML receiving intermediate-dose cytarabine induction, intensification of the cytarabine dose beyond 12 g/m(2) within first consolidation did not improve treatment outcome.

Cytarabine dose for acute myeloid leukemia. [2011.03.17]
BACKGROUND: Cytarabine (ara-C) is an important drug in the treatment of acute myeloid leukemia (AML). High-dose cytarabine (2000 to 3000 mg per square meter of body-surface area) is toxic but results in higher rates of relapse-free survival than does the conventional dose of 100 to 400 mg per square meter. Intermediate dose levels have not been thoroughly evaluated... CONCLUSIONS: Induction therapy with cytarabine at the lower dose already produced maximal antileukemic effects for all response end points, suggesting a plateau in the dose-response relationship above this dose level. High-dose cytarabine results in excessive toxic effects without therapeutic benefit. (Netherlands Trial Register number, NTR230.).

A randomized comparison of 4 courses of standard-dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in postremission therapy for acute myeloid leukemia in adults: the JALSG AML201 Study. [2011.02.24]
We conducted a prospective randomized study to assess the optimal postremission therapy for adult acute myeloid leukemia in patients younger than 65 years in the first complete remission. A total of 781 patients in complete remission were randomly assigned to receive consolidation chemotherapy of either 3 courses of high-dose cytarabine (HiDAC, 2 g/m(2) twice daily for 5 days) alone or 4 courses of conventional standard-dose multiagent chemotherapy (CT) established in the previous JALSG AML97 study...

Randomized trial of response-oriented individualized versus fixed-schedule induction chemotherapy with idarubicin and cytarabine in adult acute myeloid leukemia: the JALSG AML95 study. [2010.03]
A multicenter, prospective, randomized study was conducted to compare a response-oriented individualized remission induction therapy with a standard fixed-schedule induction therapy, using idarubicin (IDR) and cytarabine (Ara-C), in adult patients with acute myeloid leukemia (AML)...

more studies >>

Clinical Trials Related to Depocyt (Cytarabine)

A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma [Recruiting]
Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary brain tumor are inadequate and as such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. This study aims to develop a new treatment for GBM by suppressing glial progenitor cells that surround the ventricular system in patients with these aggressive tumors because it is these regions that appear to act as an incubator for future recurrences resulting in patient death. Considering the lack of significant treatment options for patients with this uniformly fatal disease, this is an important translational clinical study to perform.

High-dose Methotrexate and Liposomal Cytarabine in Treating Patients With CNS Metastases From Breast Cancer [Recruiting]
This phase II trial is studying how well giving high-dose methotrexate together with liposomal cytarabine works in treating patients with central nervous system (CNS) metastases from metastatic breast cancer. Drugs used in chemotherapy, such as methotrexate and liposomal cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose systemic methotrexate with intra-cerebral spinal fluid (CSF) liposomal cytarabine may kill more tumor cells

Study to Demonstrate the Safety of WBR Administered at the Same Time as Intrathecal Liposomal Cytarabine (DepoCyte®) Versus Intrathecal Liposomal Cytarabine (DepoCyte®) Administered After WBR for the Treatment of Solid Tumour Neoplastic Meningitis in Patients With or Without Brain Metastasis. [Not yet recruiting]
The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy (WBRT) together with intrathecal liposomal cytarabine (DepoCyte®) for patients with leptomeningeal metastases. The study will compare the safety of giving DepoCyte at the same time as WBRT with giving the drug after WBRT is complete.

A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma [Recruiting]
Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary brain tumor are inadequate and as such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. This study aims to develop a new treatment for GBM by suppressing glial progenitor cells that surround the ventricular system in patients with these aggressive tumors because it is these regions that appear to act as an incubator for future recurrences resulting in patient death. Considering the lack of significant treatment options for patients with this uniformly fatal disease, this is an important translational clinical study to perform.

Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL) [Recruiting]
Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding Ara-C in the chemotherapy of APL reduced treatment toxicity without increasing relapses. While the relapse rate for the children with white blood cell(WBC) counts greater than 10×109/L at presentation were higher than those WBC counts less than 10×109/L (31% and 3. 5%,respectively) in the LPA96 and 99 trials. A recent adult randomized trial show that avoiding Ara-C leads to an increased risk of relapse in the APL patients with WBC counts less than 10×109/L. The role of the Ara-C remains controversial. And there are very limited data reported on children with APL so far.

more trials >>

Reports of Suspected Depocyt (Cytarabine) Side Effects

Headache (9)Mucosal Inflammation (7)Arachnoiditis (6)Coma (6)Hepatic Enzyme Increased (6)Hyperkalaemia (5)Deafness (5)Pneumocystis Jiroveci Pneumonia (5)Herpes Simplex (5)Dysarthria (5)more >>


Page last updated: 2014-09-17

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