Firstline acute lymphoblastic leukemia all all and hypersensitivity to native forms of lasparaginase. The fda expanded the approved use of onscapar to include treating children and adults with newly diagnosed acute lymphoblastic leukemia all as part of a multipledrug chemotherapy regimen. Oncaspar can be given by intramuscular im injection or intravenous iv infusion. Oncaspar pegaspargase injection is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7. Baxaltas rare blood cancer drug oncaspar approved in europe first euwide licence for the acute lymphoblastic leukaemia treatment baxaltas aspirations in oncology have received a boost after the european commission approved oncaspar, its treatment for a rare form of leukaemia. Topics az slideshows images quizzes supplements medications. Drug information on oncaspar pegaspargase includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. Study 2 is an ongoing, multifactorial design study in which all patients received oncaspar as a component of various. Store oncaspar under refrigeration at 2c to 8c 36f to 46f.
The trial supporting this new indication was an open label, randomized, multicenter clinical trial that enrolled 118 children age, 19 years with previously untreated, standard risk all. Oncaspar is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of lasparaginase. See full prescribing information for 3,750 international units5 ml solution in a singleuse vial. Initial approval criteria patient is 1 year or older. After dilution, administer immediately into a running infusion of either 0. When oncaspar is administered intramuscularly, the volume at a single injection site should be limited to 2 ml. Vpriv velaglucerase alfa for injection is a prescription medication indicated for longterm enzyme replacement therapy ert for patients with type 1 gaucher disease. Lasparaginase is a tetrameric enzyme that is produced endogenously by e.
Pegaspargase pegasparjace destroys leukemia cancer cells in the first growth g 1 phase of cell life. Dec 17, 2019 oncaspar pegaspargase injection is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7. If you think someone in your family has been exposed to covid19, stay home and contact your health care provider for next steps. The recommended dose of oncaspar is 2,500 ium 2 intramuscularly im or intravenously iv. The lasparaginase used in the manufacture of pegaspargase is derived from escherichia coli 01 19. What should i discuss with my health care provider before receiving pegaspargase oncaspar. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for. Approximately twothirds of patients are able to tolerate pegaspargase. Cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Oncaspar dosage and administration recommended dosage. See the end of section 4 for how to report side effects. Find patient medical information for oncaspar injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Patients received oncaspar as a single agent or in combination with multiagent chemotherapy.
Asparaginase is contraindicated in patients with a history of an allergy to asparaginase, or past or present pancreatitis. Dailymed oncaspar pegaspargase injection, solution. It is given by injection shot into the muscle or as an infusion in the hospital or clinic. Extranodal natural killertcell lymphomanasal type authorization of 12 months may be granted for the treatment of extranodal natural killertcell lymohomanasal type when oncaspar is used in conjunction with multiagent chemotherapy. C10403 induction c10403 induction is a chemotherapy regimen for acute lymphoid leukemia all. Janu a ryfebru y 2011 oncology nurse adviso 25 pegaspargase. Oncaspar was previously approved in february 1994 for the treatment of patients with all who were hypersensitive to native forms of lasparaginase.
This acquisition is a major step in achieving the servier groups ambition, declared olivier laureau, president of servier. Managing asparaginaserelated toxicity in adult patients. The c10403 regimen is similar to treatment regimens given to pediatric patients less than 18 y. Treatment may be monitored based on the trough serum asparaginase activity measured before the. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with. Pegaspargase oncaspar, a pegylated form of native escherichia. Baxalta granted eu marketing authorization for oncaspar. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. When oncaspar is given by intramuscular injection the volume injected at one site should not exceed 2 ml in children and adolescents and 3 ml in adults. Continuation of therapy all members including new members requesting authorization for continuation of therapy must meet all initial authorization criteria. Highlights of prescribing information these highlights do not. Oncaspar 750 uml solution for injectioninfusion patient.
Oncaspar should be administered no more frequently than every 14 days. Erwinaze asparaginase erwinia chrysanthemi is an asparaginespecific enzyme 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. Oncaspar is used in conjunction with multiagent chemotherapy. Oncaspar pegaspargase injection, for intramuscular or intravenous use. Oncaspar contains pegaspargase, which is an enzyme asparaginase that breaks down asparagine, an important building block of proteins without which cells. Oct, 2017 new formulation of oncaspar pegaspargase receives positive chmp opinion in europe for patients with acute lymphoblastic leukemia all if approved, lyophilized formulation would offer three. Pegaspargase reference guide for safe and effective use from the american society of. 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. The binding preserves the enzymatic function of the drug, but decreases the immunogenicity of the protein, thus potentially reducing the risk of hypersensitivity reactions. Definition from the nci drug dictionary detailed scientific definition and other names for this drug.
Pdf pegaspargase oncaspar, a pegylated form of native. Erwinaze asparaginase erwinia chrysanthemi for injection full prescribing information 1 indications and usage erwinaze asparaginase erwinia chrysanthemi is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of patients with acute. This will allow quick identification of new safety information. Oncaspar pegaspargase is a modified version of the enzyme lasparaginase. Jan 11, 2019 oncaspar pegaspargase is supplied as a sterile solution in type i singleuse vials containing 3,750 international units of lasparaginase per 5 ml solution ndc 0944381001. The fda previously approved oncaspar only for patients with all who were unable to receive the cancer drug lasparaginase because of an allergy.
What are the possible side effects of pegaspargase oncaspar. Oncaspar pegaspargase prior auth criteria proprietary information. Each vial of oncaspar contains 3,750 international units of. For smaller volumes, the preferred route of administration is intramuscular. And patient must not have a history of serious pancreatitis, thrombosis, or hemorrhagic events. Medlineplus information on pegaspargase a lay language summary of important information about this drug that may include the following. Or o used as additional therapy in patients with a.
Oncaspar, innpegaspargase european medicines agency. 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. Oncaspar, 48 patients 81% received all 3 planned doses of oncaspar, 6 10% received 2 doses, 4 7% received 1 dose, and 1 patient 2% did not receive the assigned treatment. Vpriv should be administered under the supervision of a healthcare professional. Nov 01, 2019 oncaspar pegaspargase injection is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7. Fda accepts shires biologics license application for calaspargase pegol calpeg for acute lymphoblastic leukemia all if approved, calpeg could provide a new pegylated asparaginase first. C10403 protocol induction trial for all chemoexperts. Antineoplastic pregnancy risk category c action stimulates production of effector proteins, such as serum neopterin and 2, 5 oligodenylate synthetase. You can help by reporting any side effects you may get. Baxaltas rare blood cancer drug oncaspar approved in. Pegaspargase is also being studied in the treatment of other types of cancer. Shire plc shpg announced that the committee for medicinal products for human use chmp has recommended the approval of a freezedried formulation of oncaspar. Restricted access do not disseminate or copy without approval. Pharmacodynamics and safety of intravenous pegaspargase during remission induction in adults aged 55 years or younger with.
All members including new members requesting authorization for continuation of therapy must meet all initial authorization criteria. Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia all in paediatric patients from birth to 18 years, and adult patients. Oncaspar 750 uml solution for injectioninfusion summary. Jul 24, 2006 all patients received oncaspar at a dose of 2,000 or 2,500 ium 2 administered im or iv every 14 days. We would like to show you a description here but the site wont allow us.
The recommended dose of oncaspar is 2,500 international unitsm2 intramuscularly or intravenously. It is an oncolytic agent used in combination chemotherapy for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to native forms of lasparaginase. Each vial of oncaspar contains 3,750 international units of pegaspargase in 5 ml of solution. Hypersensitivity reactions, including serious allergic reactions anaphylaxis have occurred. Please click here for full prescribing information. Local prescribing information should be consulted for full details. The recommended dose of oncaspar is 2,500 international unitsm. Oncaspar definition of oncaspar by medical dictionary.
Oncaspar is contraindicated in patients with a history of serious allergic reactions to oncaspar, and in patients with a history of serious thrombosis, pancreatitis, or serious hemorrhagic events with prior lasparaginase therapy. Baxalta announced that the european commission has granted marketing authorization for use of oncaspar as a combination therapy for acute lymphoblasti. Visiting standards have been updated to allow only two legal guardians at the bedside during a patients stay. Pegaspargase oncaspar medical clinical policy bulletins. Oncaspar pegaspargase injection, for intramuscular or intravenous contraindicationsuse history of serious allergic reactions to oncaspar.
Deviations in diagnosis, dosage amount, dosing interval from the initial or subsequent. Fda accepts shires biologics license application for. What is the most important information i should know about pegaspargase oncaspar. Information for the user oncaspar 750 uml solution. Highlights of prescribing information neulasta safely and. The c10403 regimen is an aggressive and complex treatment regimen for adolescents and young adults aya with all. Oncaspar fda prescribing information, side effects and uses. Oncaspar 750 uml solution for injectioninfusion pegaspargase. To produce oncaspar, lasparaginase is modified by covalently conjugating units of monomethoxypolyethylene glycol peg, molecular weight of 5,000, to the enzyme, forming the active ingredient peglasparaginase.
Dailymed oncaspar pegaspargase injection, solution for. Highlights of prescribing information urothelial carcinoma. Pegaspargase oncaspar childrens education materials. Oncaspar pegaspargase side effects, images, uses, dosage. Servier finalizes acquisition of shires oncology branch.
Highlights of prescribing information these highlights do. Oncaspar is indicated as a component of a multiagent chemotherapeutic regimen for the firstline treatment of pediatric and adult patients with all. If hypersensitivity occurs, e carotovora asparaginase may be tolerated if available. Listing a study does not mean it has been evaluated by the u. This patients benefit plan requires prior authorization for certain medications in order for the drug to be covered. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
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