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)
Test shown to reduce early chronic lymphocytic leukemia deaths is now available to patients
Source: Health News from Medical News Today [2013.11.30]
SignatureCLL have announced that the first laboratory test ever shown in a clinical trial to improve one year survival rates in cancer is now available to patients with chronic lymphocytic leukemia (also called CLL). The U.S. cancer physician who invented the test and the British scientist who used it to make discoveries in leukemia will offer the test under the trade name SignatuRx™ through their own, newly-formed laboratory company.
Key findings for the prevention, diagnosis, treatment and potential cure for acute myeloid leukemia
Source: Genetics News From Medical News Today [2013.11.27]
Acute myeloid leukemia (AML) is a group of heterogeneous diseases with considerable diversity in terms of genetic abnormalities. Mutations of CEBPA, a tumour suppressor, are found in about 10 per cent of human AML patients.
Drug may enhance the effectiveness of bone marrow transplants for select pediatric leukemia patients
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.11.19]
Combining the drug gemtuzumab ozogamicin (GO) with conventional chemotherapy may improve the outcome of bone marrow transplantation for some children battling high-risk acute myeloid leukemia (AML), according to a study led by St. Jude Children's Research Hospital. The results appear in the current edition of the journal Cancer.
FDA approves Roche's Gazyva (obinutuzumab) for people with previously untreated chronic lymphocytic leukemia (CLL)
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.11.05]
Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL).
Gazyva Approved for Chronic Lymphocytic Leukemia
Source: MedicineNet Leukemia Specialty [2013.11.04]
Title: Gazyva Approved for Chronic Lymphocytic Leukemia
Category: Health News
Created: 11/1/2013 12:35:00 PM
Last Editorial Review: 11/4/2013 12:00:00 AM
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)
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
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]
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: 2013-11-30