Erwinia asparaginase after allergy to e coli asparaginase. There was some slow movement of asparaginase from vascular to. Guidelines for asparaginase administration asparaginase is an antineoplastic agent used most effectively and commonly in pediatrics in the treatment of acute lymphocytic leukemia all, lymphoblastic lymphoma, and acute myeloid leukemia aml. Erwinaze asparaginase erwinia chrysanthemi rationale for inclusion in pa program. Food and drug administration fda name is cryoprecipitated antihemophilic factor, is the coldinsoluble portion of fresh frozen plasma ffp that precipitates when ffp is thawed at refrigerator temperatures 16 c. After resolution, treatment with erwinaze may be resumed.
This drug may have toxic properties and must be handled and administered with care. Dec 05, 2018 cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. Treatment may be monitored based on the trough serum asparaginase activity measured before the. Lasparaginase and peg asparaginase past, present, and.
No activity was detected in urine after administration at a small dose. Erwinaze asparaginase erwinia chrysanthemi for injection, intramuscular im or intravenous iv use. Pegaspargase oncaspar medical clinical policy bulletins. When l asparaginase was intravenously administered in rats at a dose as large as 50,000 to 100,000 kukg, only 0. The nccn compendium is a derivative work of the nccn guidelines. Anti asparaginase antibodies may be associated with low asparaginase activity levels due to potential neutralising activity of these antibodies. Erwinaze asparaginase erwinia chrysanthemi for injection, intramuscular use. Asparaginase products are isolated from different types of bacteria, namely escherichia coli and erwinia chrysanthemi. Erwinaze batch 198k notice of new special handling instructions use a 0. Pegaspargase oncaspar is a conjugate of monomethoxypolyethylene glycol mpeg and lasparaginase lasparagine amidohydrolase, an asparagine specific enzyme. The mean t12 of peg l asparaginase was 357 hours compared with 20 hours for l asparaginase.
Hycamtin for injection,in combination with cisplatin,is indicated for the treatment of patients with stage ivb, recurrent, or persistent cervical cancernot amenable to curative treatment. E coli asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia all. In this study, we describe the use of in vitro directed evolution to create a new enzyme variant with improved thermal stability. Asparaginase is contraindicated in patients with a history of an allergy to asparaginase, or past or present pancreatitis. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with. As a medication, lasparaginase is used to treat acute lymphoblastic leukemia all, acute myeloid leukemia aml, and nonhodgkins lymphoma. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Highlights of prescribing information these highlights do. Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule. Janu a ryfebru y 2011 oncology nurse adviso 25 pegaspargase. Find out what health conditions may be a health risk when taken with asparaginase injection. Oncaspar fda prescribing information, side effects and uses. The recommended dose is 25,000 international unitsm.
A promising enzyme for treatment of acute lymphoblastic leukiemia richa jain, k. Sections or subsections omitted from the full prescribing information are not listed. In food manufacturing it is used to decrease acrylamide. Lasparaginase is an antitumor agent derived from li. Lasparaginase is a tetrameric enzyme consisting of four identical subunits, each having a molecular weight of about 35 kda. The aim of this study was to purify and characterize lasparaginase from phaseolus vulgaris seeds instead of microbial sources. Hypersensitivity to asparaginase was defined by a history of systemic rash, urticaria, bronchospasm, laryngeal edema, hypotension, or local erythema, urticaria, or swelling, greater than 2 centimeters, for at least 10 minutes following administration of any form of native e. It is given by injection into a vein, muscle, or under the skin. Managing asparaginaserelated toxicity in adult patients. Dec 23, 2015 a read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Intravenous administration of lasparginase concurrently with or immediately before a course of vincristine and prednisolone may elicit increased toxicity. Highlights of prescribing information these highlights do not include all the information needed to use thyrogen safely and effectively.
Webmd provides common contraindications for asparaginase injection. Erwinaze asparaginase erwinia chrysanthemi is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia all who have developed hypersensitivity to e. Lasparaginase for injection prescribing information getwell. L asparaginase is an enzyme that catalyzes the conversion of the amino acid lasparagine into aspartic acid and ammonia.
They inhibit protein synthesis in tumor cells by depriving them of. Oncaspar, innpegaspargase european medicines agency. L asparaginase is modified by covalently conjugating units of monomethoxypolyethylene glycol peg, which has a molecular weight of 5000, to the enzyme, forming the active ingredient peg l asparaginase 01 19. Preparation instructions 1 visually inspect the erwinaze powder for foreign particulate matter and discoloration prior to reconstitution. Oncaspar is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of patients with all and hypersensitivity to native forms of lasparaginase. The recommended dosage of hycamtin for injection is 0. Pegaspargase oncaspar is a conjugate of monomethoxypolyethylene glycol mpeg and l asparaginase lasparagine amidohydrolase, an asparagine specific enzyme.
In the case of mild pancreatitis, hold erwinaze until the signs and symptoms subside and amylase levels return to normal. In such cases, a switch to a different asparaginase preparation should be considered. Acute lymphoblastic leukemia and hypersensitivity to asparaginase 1. L asparaginase was purified to apparent homogeneity. Acute lymphoblastic leukemia all is a hematologic malignancy that predominantly occurs in children between 2 and 10 years of age. Erwinaze asparaginase erwinia chrysanthemi is an asparaginespecific enzyme lasparaginase is a tetrameric enzyme consisting of four identical subunits, each having a.
Lasparaginase is an integral component of treatment for patients with all and since its introduction into pediatric treatment protocols in the 1960s, survival rates in children have progressively risen to nearly 90%. Lasparaginase is an enzyme which hydrolyses asparagine. Asparaginase asparaginase erwinia chrysanthemi contains an asparagine specific enzyme derived from erwinia chrysanthemi. Pdf lasparaginase in the treatment of patients with acute. Engineering thermal stability of lasparaginase by in. Elspar asparaginase for injection, intravenous or intramuscular initial u. They inhibit protein synthesis in tumor cells by depriving them of the amino acid asparagine. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package.
Lasparaginase is an enzyme that catalyzes the conversion of the amino acid lasparagine into aspartic acid and ammonia. Dailymed oncaspar pegaspargase injection, solution for. Purification and characterization of asparaginase from. Asparaginase is an enzyme that is used as a medication and in food manufacturing. Guidelines for the administration of cryoprecipitate introduction cryoprecipitate, or cryo, whose official u. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. Reconstitute by adding water for injection into the vial of lasparaginase.
Erwinaze asparaginase erwinia chrysanthemi rationale. Different isozymes of this enzyme have been isolated from a wide range of organisms, including plants and terrestrial and marine. We assessed the nadir enzyme activity and tolerability of erwinia asparaginase, an. Approximately 69 to 82 molecules of mpeg are linked to l asparaginase. Erwinaze asparaginase erwinia chrysanthemi from batch 198k. The aim of this study was to purify and characterize l asparaginase from phaseolus vulgaris seeds instead of microbial sources. The major side effects were nausea and vomiting, peripheral edema, hypoalbuminemia and hepatic dysfunction. In some cases, health care professionals may use the trade name elspar or other names lasparaginase or kidrolase or erwinia lasparaginase when referring to the generic drug name asparaginase. Pegaspargase oncaspar the authors make no claims of the accuracy of the information contained herein. Firstline acute lymphoblastic leukemia all all and hypersensitivity to native forms of l asparaginase.
The activity of asparaginase is expressed in terms of international units. The purpose of this letter is to alert you that erwinaze asparaginase erwinia chrysanthemi from batch 198k may be administered either intramuscularly im or intravenously iv according to the instructions outlined in this letter that are intended to. L asparaginase is an antineoplastic agent that is fda approved for the treatment of as a component of a multiagent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia all who have developed hypersensitivity to e. Lasparaginase from bacteria has been used in treatment of acute lymphoblastic leukemia. Highlights of prescribing information these highlights do not include all the information needed to use blincyto safely and effectively. L asparaginase is an integral component of treatment for patients with all and since its introduction into pediatric treatment protocols in the 1960s, survival rates in children have progressively risen to nearly 90%. Asparaginase is an anticancer antineoplastic or cytotoxic chemotherapy drug.
Do not interchange elspar with erwinia asparaginase or pegylated. L asparaginase from bacteria has been used in treatment of acute lymphoblastic leukemia. Erwinia asparaginase after allergy to e coli asparaginase in. The purified asparaginase had very low activity toward a number of. The purified asparaginase had very low activity toward a number of asparagine and. Asparaginase is an enzyme that catalyzes the hydrolysis of lasparagine to laspartic acid and ammonia. It is used mainly for the induction of remission in acute lymphoblastic leukaemia. Firstline acute lymphoblastic leukemia all all and hypersensitivity to native forms of lasparaginase. Engineering thermal stability of lasparaginase by in vitro. Drug interactions reversible decreases in steadystate plasma digoxin concentrations and renal glycoside. If hypersensitivity occurs, e carotovora asparaginase may be tolerated if available. Confirm the formulation of asparaginase prior to administration. Jul 24, 2006 hypersensitivity to asparaginase was defined by a history of systemic rash, urticaria, bronchospasm, laryngeal edema, hypotension, or local erythema, urticaria, or swelling, greater than 2 centimeters, for at least 10 minutes following administration of any form of native e.
Highlights of prescribing information for intravenous. Highlights of prescribing information these highlights do not. L asparaginase is an enzyme that depletes lasparagine an important nutrient for cancer cells resulting in cancertumor cell starvation. Pdf lasparaginase in the treatment of patients with. Approximately twothirds of patients are able to tolerate pegaspargase. Lasparaginase was purified to apparent homogeneity. Read all of this leaflet carefully before you start receiving this medicine because it contains important. Oncaspar activity is expressed in international units.
Guidelines for the administration of cryoprecipitate. Lasparaginase is modified by covalently conjugating units of monomethoxypolyethylene glycol peg, which has a molecular weight of 5000, to the enzyme, forming the active ingredient peg lasparaginase 01 19. Since the 1960s it has been known that some leukemic cells are deficient in asparagine synthetase and therefore cannot manufacture sufficient quantities of this essential amino acid to maintain cell viability. Pegaspargase is a modified version of the enzyme lasparaginase 01 19.
574 674 1410 281 449 529 212 11 568 62 926 1179 817 188 65 951 1089 1310 443 500 547 1190 799 1516 476 252 516 1353 112 1021 1148 26 653 1339 932 662 1244 484 1400 1200 1339