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Depocyt (Cytarabine) - Summary

 
 



WARNING: CHEMICAL ARACHNOIDITIS

Chemical arachnoiditis, a syndrome manifested primarily by nausea, vomiting, headache and fever, was a common adverse event in all clinical studies. If left untreated, chemical arachnoiditis may be fatal. Patients receiving DepoCyt should be treated concurrently with dexamethasone to mitigate the symptoms of chemical arachnoiditis. [see Warnings and Precautions (5.1, 5.2)]

 

DEPOCYT SUMMARY

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)

Meningitis Quiz: Test Your Infectious Disease IQ
Source: MedicineNet Encephalitis and Meningitis Specialty [2017.09.20]
Title: Meningitis Quiz: Test Your Infectious Disease IQ
Category: MedicineNet Quiz
Created: 10/15/2012 2:38:00 PM
Last Editorial Review: 9/20/2017 12:59:49 PM

Pharmacist Faces Trial Over Deadly U.S. Meningitis Outbreak
Source: MedicineNet Encephalitis and Meningitis Specialty [2017.09.19]
Title: Pharmacist Faces Trial Over Deadly U.S. Meningitis Outbreak
Category: Health News
Created: 9/18/2017 12:00:00 AM
Last Editorial Review: 9/19/2017 12:00:00 AM

Meningitis
Source: MedicineNet sulfamethoxazole and trimethoprim Specialty [2017.05.18]
Title: Meningitis
Category: Symptoms and Signs
Created: 12/2/2013 12:00:00 AM
Last Editorial Review: 5/18/2017 12:00:00 AM

more news >>

Published Studies Related to Depocyt (Cytarabine)

Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. [2013]
Improving outcomes in older adults with acute myeloid leukemia remains a formidable challenge. Lintuzumab (SGN-33; HuM195) is a humanized monoclonal antibody directed against CD33, which is expressed on the majority of myeloblasts in acute myeloid leukemia... These results confirm that lintuzumab in combination with low-dose cytarabine did not prolong survival and that low-dose cytarabine remains a valid comparator for trials of non-intensive therapies in older patients with acute myeloid leukemia, regardless of cytogenetic profile.

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...

more studies >>

Clinical Trials Related to Depocyt (Cytarabine)

DepoCyt Plus Temozolomide in Patients With Neoplastic Meningitis [Terminated]
Objectives:

- To determine the safety, tolerability and maximum tolerated dose (MTD) of oral

temozolomide using a 7 days on and 7 days off regimen combined with intrathecal liposomal cytarabine (DepoCyt) in patients with neoplastic meningitis from solid tumors and systemic lymphoma.

Depocyt® With Sorafenib in Neoplastic Meningitis [Terminated]
The purpose of this study is to determine the tolerability and side effects of oral sorafenib in combination with intrathecal DepoCyt.

A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma [Terminated]
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.

Liposomal Cytarabine for Central Nervous System (CNS)-Treatment in High-risk Acute Lymphoblastic Leukemia (ALL) [Suspended]

- Replacement of intrathecal Triple (methotrexate, cytarabine, prednisolone) with

intrathecal liposomal cytarabine and prednisolone during maintenance therapy will decrease the CNS relapse rate in high-risk ALL patients.

- Both acute and long-term toxicity are equal in both treatment arms.

DepoCyt for Active Lymphomatous or Leukemic Meningitis [Terminated]
The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined.

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: 2017-09-20

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