These highlights do not include all the information needed to. Oncaspar pegaspargase injection, for intramuscular or intravenous use initial u. A component of a multiagent chemotherapeutic regimen as a first line treatment for acute lymphoblastic leukemia all a component of a multiagent chemotherapeutic regimen for the treatment of patients with. For the first line treatment for acute lymphoblastic leukemia all.
Highlights of prescribing information these highlights do not include all the information needed to prescribe oncasparq. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Pegaspargase is injected into a muscle or into a vein through an iv. Pegaspargase oncaspar, calaspargase pegolmknl asparlas reference number. When utilized as a component of induction therapy for all, 1 dose of oncaspar achieved similar levels of asparagine depletion as 9 doses of native lasparaginase. In study 1, detailed safety information was collected for prespecified adverse reactions identified as asparaginaseinduced adverse reactions and for grade 3 and 4 nonhematologic adverse reactions according to the children. Acute lymphoblastic leukemia all is a hematologic malignancy that predominantly occurs in children between 2 and 10 years of age. Read more about the prescription drug pegaspargase injection.
See full prescribing information for 3,750 international units5 ml solution in a singleuse vial. One ml of solution contains 750 units u of pegaspargase. Highlights of prescribing information urothelial carcinoma. To define and describe the accepted indications for oncaspar pegaspargase usage in the treatment of cancer ii. Consumer information about the medication pegaspargase injection oncaspar, includes side effects, drug interactions, recommended dosages, and storage information. Please complete the cardholder portion, and have the prescribing physician complete portion and submit this completed form. Pegaspargase injection oncaspar side effects, medical. Prograf tacrolimus capsules, for oral use prograf tacrolimus injection, for intravenous use prograf granules tacrolimus for oral suspension. 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. In study 1, detailed safety information was collected for prespecified adverse reactions identified as asparaginaseinduced adverse reactions and for grade 3 and 4 nonhematologic adverse reactions according to the. Information for the user oncaspar 750 uml solution. Highlights of prescribing information these highlights do not.
Buy oncaspar pegaspargase 3,750 iu 5 ml online india with. Oncaspar 750 uml solution for injectioninfusion summary. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is. Our portfolio of oncology products used to treat many kinds of cancer, including leukemia, breast and ovarian cancer, bone and lung cancer, brain cancer, colon cancer, and cancer of the pancreas. The costeffectiveness of pegaspargase versus native asparaginase. Rituximab is used to reduce the number of bcells in your blood and y90 zevalin is given to treat your nonhodgkins lymphoma nhl. Oncaspar is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7.
See full prescribing information for oncasparq oncasparq. Oncaspar pegaspargase is indicated as a component of a. Jan 28, 2020 the objective of this manuscript is to provide the reader with two examples on how to present an immunogenicity risk assessment for a pegylated therapeutic as part of investigational new drug ind application or during other stages of the drug development process. Jan 11, 2019 oncaspar activity is expressed in international units. Study dfci 11001 enrolled both standard and highrisk all patients. What is the dosage and form of oncaspar is available.
Pegaspargase oncaspar medical clinical policy bulletins. Each vial of oncaspar contains 3,750 international units of pegaspargase in 5 ml of solution. Highlights of prescribing information these highlights do. A healthcare provider will give you this injection. These highlights do not include all the information needed to use oncaspar safely and effectively. See 17 for patient counseling information and medication guide. Side effects of oncaspar pegaspargase, warnings, uses. Further information on oncaspar 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 is authorised for use in the european union. The information provided on this form will be used to determine the provision of healthcare benefits under a u. The use of oncaspar in place of lasparaginase reduces the number of drug injections required, from 21 injections of lasparaginase to three injections with oncaspar over the 20week course of treatment. Background firstline treatment of acute lymphoblastic leukemia all pegaspargase oncaspar is a conjugate of monomethoxypolyethylene glycol mpeg and lasparaginase lasparagine amidohydrolase, an asparagine specific enzyme.
In order to provide context to the bioanalytical strategies used to support the pegylated therapeutics presented here, a. Oncaspar injection for intramuscular and intravenous use prescribing information. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with. Oncaspar pegaspargase 750 uml solution for injectioninfusion prescribing information refer to summary of product characteristics spc before prescribing. The objective of this manuscript is to provide the reader with two examples on how to present an immunogenicity risk assessment for a pegylated therapeutic as part of investigational new drug ind application or during other stages of the drug development process. A component of a multiagent chemotherapeutic regimen as a firstline treatment of pediatric and. Description pegaspargase oncaspar is an asparagine specific enzyme. Oncaspar pegaspargase 750 uml solution for injection. Oncaspar pegaspargase dose, indications, adverse effects.
Firstline treatment of acute lymphoblastic leukemia all pegaspargase oncaspar is a conjugate of monomethoxypolyethylene glycol mpeg and lasparaginase l asparagine amidohydrolase, an asparagine specific enzyme. Nov 01, 2019 oncaspar pegaspargase injection is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7. Oncaspar pegaspargaseinjection, for intramuscular or intravenous use initial u. Jul 24, 2006 per protocol, the schedule of oncaspar varied by treatment arm, with intermittent doses of oncaspar for up to 10 months. Oncaspar pegaspargase injection is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7. Vpriv should be administered under the supervision. The fda previously approved oncaspar only for patients with all who were unable to receive the cancer drug lasparaginase because of an allergy. Onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to onivyde or irinotecan hcl. History of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients. You will be watched closely for at least 1 hour after receiving pegaspargase, to make sure you do not have an allergic reaction to the medication. Oncaspar fda prescribing information, side effects and uses.
Pegaspargase is also being studied in the treatment of other types of cancer. Hypersensitivity reactions, including serious allergic reactions anaphylaxis have occurred. Medlineplus information on pegaspargase a lay language summary of important information about this drug that may include the following. Elspar is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia all. Oncaspar is available as 3,750 international units5 ml solution in a singleuse vial. This letter is not intended as a complete description of the benefits and risks related to the use of oncaspar.
Please refer to the attached full prescribing information. Jan 11, 2019 per protocol, the schedule of oncaspar varied by treatment arm, with intermittent doses of oncaspar for up to 10 months. Immunogenicity risk assessment for pegylated therapeutics. Oncaspar, innpegaspargase european medicines agency. Click here to download full prescribing information. Feb 06, 2020 pegaspargase is injected into a muscle or into a vein through an iv. Pegaspargase, as part of multidrug chemotherapy, is a costeffective. Dailymed oncaspar pegaspargase injection, solution for. Sylatron peginterferon alfa2b for injection, for subcutaneous use. The nccn acute lymphoblastic leukemia clinical practice guidelines in oncology version 1. Oncaspar can be administered through intramuscular im injection or intravenous iv infusion.
If immediate use is not possible, the diluted solution can be stored at 2c8. Oncaspar efficacy and safety were evaluated on the basis of three clinical studies using oncaspar solution for injectioninfusion in the first line treatment of all. This medicinal product is subject to additional monitoring. See full prescribing information for 3,750 international units5 ml. This clinical policy is consistent with standards of medical. A new look at peglasparaginase and other asparaginases in hematological malignancies. Per protocol, the schedule of oncaspar varied by treatment arm, with intermittent doses of oncaspar for up to 10 months. Short bowel syndrome is a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed. It is the policy of health plans affiliated with centene corporation that erwinaze is. Lasparaginase is an integral component of treatment for patients with all and since its introduction into pediatric treatment. Highlights of prescribing information these highlights do not include all the information needed to prescribe dosage forms and strengthsoncaspar safely and effectively. The health plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. Zevalin therapy to treat nonhodgkins follicular lymphoma. After the medicinal product has been diluted, the solution should be used immediately.
Revestive is a medicine for treating short bowel syndrome or short gut in adults and children aged 1 year and above. Highlights of prescribing information these highlights do not include all the information needed to use sylatron safely and effectively. Lasparaginase in the treatment of patients with acute. November, 2011 full prescribing information contents 1 indications and usage 2 12.
Our portfolio of oncology products used to treat many kinds of cancer, including leukemia, breast and ovarian cancer, bone and lung cancer, brain. Vpriv velaglucerase alfa for injection is a prescription medication indicated for longterm enzyme replacement therapy ert for patients with type 1 gaucher disease. In order to provide context to the bioanalytical strategies used to support the pegylated therapeutics presented here, a brief. Fda accepts shires biologics license application for. What is the highlights of prescribing information of oncaspar. One international unit of lasparaginase is defined as the amount of enzyme required to generate 1 micromole of ammonia per minute at ph 7. Oncaspar pegaspargase injection, for intramuscular or intravenous use. Fda approved indications oncaspar is indicated as a component of a multiagent chemotherapeutic regimen. History of serious thrombosis with prior lasparaginase therapy. Highlights of prescribing information these highlights do not include all the information needed to prescribe dosage forms and strengths oncaspar safely and effectively.
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