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Elspar (Asparaginase) - Summary

 
 



WARNINGS

It is recommended that asparaginase be administered to patients only in a hospital setting under the supervision of a physician who is qualified by training and experience to administer cancer chemotherapeutic agents, because of the possibility of severe reactions, including anaphylaxis and sudden death. The physician must be prepared to treat anaphylaxis at each administration of the drug. In the treatment of each patient the physician must weigh carefully the possibility of achieving therapeutic benefit versus the risk of toxicity.

Special handling procedures should be followed (see DOSAGE AND ADMINISTRATION, Special Handling).

 

ELSPAR SUMMARY

ELSPAR * (Asparaginase) contains the enzyme L-asparagine amidohydrolase, type EC-2, derived from Escherichia coli. It is a white crystalline powder that is freely soluble in water and practically insoluble in methanol, acetone and chloroform. Its activity is expressed in terms of International Units (I.U.) according to the recommendation of the International Union of Biochemistry. The specific activity of ELSPAR is at least 225 I.U. per milligram of protein and each vial contains 10,000 I.U. of asparaginase and 80 mg of mannitol, an inactive ingredient, as a sterile, white lyophilized plug or powder for intravenous or intramuscular injection after reconstitution.

ELSPAR is indicated in the therapy of patients with acute lymphocytic leukemia. This agent is useful primarily in combination with other chemotherapeutic agents in the induction of remissions of the disease in pediatric patients. ELSPAR should not be used as the sole induction agent unless combination therapy is deemed inappropriate. ELSPAR is not recommended for maintenance therapy.


See all Elspar indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Elspar (Asparaginase)

Treatment-resistant leukemias may be vulnerable to experimental drug
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.04.11]
Research in mice and human cell lines has identified an experimental compound dubbed TTT-3002 as potentially one of the most potent drugs available to block genetic mutations in cancer cells blamed...

New approach to leukemia testing may better define prognosis, treatment
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.04.01]
Nearly half of patients with the most common form of adult leukemia are said to have normal chromosomes but appear instead to have a distinct pattern of genetic abnormalities that could better define...

Patients susceptible to leukemia treatment aftermaths identified
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.03.25]
The National Institute of Pediatrics (INP) in Mexico, conducted a study on genetic markers to identify children with acute leukemia, who may suffer side effects from the medications used to treat...

Chronic lymphocytic leukemia: Editorial published by North Shore-LIJ Cancer Institute doctors
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.03.23]
Two North Shore-LIJ Cancer Institute doctors, world-renowned for their research in chronic lymphocytic leukemia (CLL), weigh in on a German study of a new drug therapy for CLL in the New England...

New drug offers potential for chemo-free treatment for leukemia/lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.03.21]
Patients with terminal forms of leukaemia and lymphoma who have run out of treatment options could soon benefit from a new drug, which not only puts an end to chemotherapy and has virtually no side...

more news >>

Published Studies Related to Elspar (Asparaginase)

l-asparaginase loaded red blood cells in refractory or relapsing acute lymphoblastic leukaemia in children and adults: results of the GRASPALL 2005-01 randomized trial. [2011.04]
l-asparaginase encapsulated within erythrocytes (GRASPA((R)) ) should allow serum asparagine depletion over a longer period than the native form of the enzyme, using lower doses and allowing better tolerance. The GRASPALL 2005-01 study, a multicentre randomized controlled trial, investigated three doses of GRASPA((R)) for the duration of asparagine depletion in a phase I/II study in adults and children with acute lymphoblastic leukaemia (ALL) in first relapse.

Asparaginase-related venous thrombosis in UKALL 2003- re-exposure to asparaginase is feasible and safe. [2010.05]
We report the incidence and outcome of venous thrombosis (VT) in the UK acute lymphoblastic leukaemia (ALL) 2003 trial. VT occurred in 59/1824 (3.2%) patients recruited over 5 years with 90% occurring during a period of Asparagine depletion... This report confirms a significant risk of thrombosis with such therapy, but demonstrates that re-exposure to Asparaginase is feasible and safe.

Comparison of native E. coli and PEG asparaginase pharmacokinetics and pharmacodynamics in pediatric acute lymphoblastic leukemia. [2009.12]
Asparaginase (ASP) is used routinely in frontline clinical trials for the treatment of childhood acute lymphoblastic leukemia (ALL). The goals of this study were to assess the pharmacokinetics and pharmacodynamics of ASP and to mathematically model the dynamics between ASP and asparagine (ASN) in relapsed ALL...

Pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant asparaginase preparation in children with previously untreated acute lymphoblastic leukemia: a randomized phase 2 clinical trial. [2008.12.15]
The pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant Escherichia coli-asparaginase preparation was compared with Asparaginase medac. Thirty-two children with acute lymphoblastic leukemia were randomized to receive one of both agents at a dose of 5000 U/m(2) every 3 days, for a total of 8 doses during induction treatment...

Pharmacokinetics, pharmacodynamics, efficacy and safety of a new recombinant asparaginase preparation in children with previously untreated acute lymphoblastic leukemia- a randomized phase II clinical trial. [2008.09.19]
The pharmacokinetics, pharmacodynamics, efficacy and safety of a new recombinant E.coli-asparaginase preparation was compared to the commercially available asparaginase preparation Asparaginase medac(TM). 32 children with de novo ALL were randomized to receive one of both agents at a dose of 5,000 U/m(2) every 3 days for a total of 8 doses during induction treatment...

more studies >>

Clinical Trials Related to Elspar (Asparaginase)

Erwinase Study in Patients With Acute Lymphoblastic Leukemia [Recruiting]
The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to E. coli L-asparaginase or Pegylated E. coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia (ALL).

ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase [Recruiting]
The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival

A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy [Recruiting]
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are >0. 1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.

Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Patients (Adults/Children) With Relapse of Acute Lymphoblastic Leukemia [Recruiting]
This study is run to confirm the benefit/risk profile of GRASPA® at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase.

Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage [Recruiting]

more trials >>

Reports of Suspected Elspar (Asparaginase) Side Effects

Embolism (47)Infection (40)Neutropenia (37)Osteonecrosis (34)Convulsion (15)Toxicity TO Various Agents (14)Pyrexia (11)Embolism Venous (11)OFF Label USE (10)Death (8)more >>


Page last updated: 2014-04-11

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