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 * (Asparaginase) contains the enzyme L-asparagine amidohydrolase, type EC-2, derived from
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.
Media Articles Related to Elspar (Asparaginase)
Bone loss associated with leukemia therapy occurs sooner than previously thought
Source: Bones / Orthopedics News From Medical News Today [2016.02.05]
Investigators at Children's Hospital Los Angeles have found that significant bone loss - a side effect of chemotherapy for acute lymphoblastic leukemia (ALL) - occurs during the first month of...
New assay detects persistent disease in leukemia patients thought to be in remission
Source: Blood / Hematology News From Medical News Today [2016.02.04]
The outcomes of chronic myeloid leukemia (CML) have dramatically improved as the result of tyrosine kinase inhibitor (TKI) treatment.
Source: MedicineNet Anemia Specialty [2016.02.03]
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 2/3/2016 12:00:00 AM
Standard BMI inadequate for tracking obesity during leukemia therapy
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.01.29]
An interdisciplinary research team at The Saban Research Institute of Children's Hospital Los Angeles has found that body mass index (BMI) is an inadequate method for estimating changes in body fat...
FDA approve Arzerra (ofatumumab) as extended treatment for recurrent or progressive chronic lymphocytic leukemia
Source: Blood / Hematology News From Medical News Today [2016.01.20]
Genmab A/S has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) for extended...
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...
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
Reports of Suspected Elspar (Asparaginase) Side Effects
Toxicity TO Various Agents (14),
Embolism Venous (11),
OFF Label USE (10),
Death (8), more >>
Page last updated: 2016-02-05