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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)

Relapse in leukemia tied to mutations that persist through treatment
Source: Cancer / Oncology News From Medical News Today [2015.08.26]
Focusing on mutations that linger through chemotherapy instead of those present at time of diagnosis may be a better way to predict relapse and survival in acute myeloid leukemia.

Genetic mutations identified during remission may help predict risk of relapse, survival for leukemia patients
Source: Genetics News From Medical News Today [2015.08.26]
In preliminary research, the detection of persistent leukemia-associated genetic mutations in at least 5 percent of bone marrow cells in day 30 remission samples among adult patients with acute...

New similarities between Leukemia and AIDS discovered by Ben-Gurion University of the Negev researchers
Source: HIV / AIDS News From Medical News Today [2015.08.26]
Researchers at Ben-Gurion University of the Negev (BGU) have made a significant breakthrough, discovering similarities between Leukemia and HIV that might hold the key to developing a clinical...

Basis for new treatment options for a fatal leukemia in children revealed
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.07.29]
Detailed molecular analyses allow new insights into the function of tumor cells and options for new treatmentsAcute lymphoblastic leukemia (ALL) leukemia is the most common type of cancer in...

New treatment options for a fatal leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.07.28]
Acute lymphoblastic leukemia (ALL) frequently develops between the age of two and three.

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)

Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML) [Recruiting]
Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6 doses MWF over a period of 2 weeks to 9 patients (as described below and in the following schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation studies including fibrinogen will be measured and reviewed before each asparaginase dose. Fibrinogen (<100 mg/dL) can be replaced with cryoprecipitate before each dose at the discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase or direct bilirubin above normal range.

Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia [Active, not recruiting]
This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Erwinase Study in Patients With Acute Lymphoblastic Leukemia [Completed]
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) or T or B cell lymphoma. This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.

GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia [Active, not recruiting]
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics, tolerability and maintain circulating asparaginase activity due to the protective barrier of the erythrocyte membrane. 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.

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

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: 2015-08-26

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