Severe mucocutaneous reactions, some with fatal outcomes 5. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Oncaspar pegaspargase is a modified version of the enzyme lasparaginase. Highlights of prescribing information patients 12 years of. Janu a ryfebru y 2011 oncology nurse adviso 25 pegaspargase. Pharmacodynamics and safety of intravenous pegaspargase. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Mechanism of action the mechanism of action of oncaspar is thought to be based on selective killing of leukemic cells due to depletion of plasma asparagine. Managing asparaginaserelated toxicity in adult patients.
Highlights of prescribing information these highlights do not include all the information needed to use tracleer safely and effectively. However, pegaspargase should not be routinely substituted for lasparaginase. The c10403 regimen is similar to treatment regimens given to pediatric patients less than 18 y. Empliciti elotuzumab for injection, for intravenous use initial u. Oncaspar fda prescribing information, side effects and uses. Treatment may be monitored based on the trough serum asparaginase activity measured before the.
According to the international versions of the package insert, allergic reactions including anaphylaxis are the most common adverse reaction when taking. An increase in palifermin concentrations occurred at around 2 to 4 hours postdose for some subjects, which was followed by a second, slow decline phase. Highlights of prescribing information these highlights do not include all the information needed to use pegasyssafely and effectively. Hepagam b is a hbig approved by the fda to prevent hbv recurrence following liver transplantation and provide postexposure prophylaxis. Leukine sargramostim a recombinant gmcsfyeastexpressed. Medlineplus information on pegaspargase a lay language summary of important information about this drug that may include the following.
Lasparaginase is defined as the quantity of enzyme required. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with. Cancidas is indicated for the treatment of candidemia and the following candida infections. Pegaspargase has a longer halflife and decreased toxicity.
In patients taking lysodren, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Mepron oral suspension is contraindicated in patients who develop or have a history of. Age 1 to 16 years did not affect the pharmacokinetics of palifermin over the dose range 40 to 80 mcgkg. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. The c10403 regimen is an aggressive and complex treatment regimen for adolescents and young adults aya with all. Pharmacodynamics and safety of intravenous pegaspargase during remission induction in adults aged 55 years or younger with newly diagnosed acute lymphoblastic leukemia. 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. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for. 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. Oxaliplatin 5mgml concentrate for solution for infusion. 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.
Fortytwo patients who previously demonstrated hypersensitivity to other lasparaginases were treated with pegaspargase and other induction agents. Protonix pantoprazole sodium dosage and administration. Indications the indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Pegaspargase oncaspar medical clinical policy bulletins. For the treatment of acute lymphoblastic leukemia all or lymphoblastic lymphoma when the requested medication is used in conjunction with multiagent chemotherapy. Local prescribing information should be consulted for full details.
Asparaginase is contraindicated in patients with a history of an allergy to asparaginase, or past or present pancreatitis. Pegaspargase, a pegylated asparaginase, is a core component in. Pegaspargase oncaspar the authors make no claims of the accuracy of the information contained herein. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Approximately twothirds of patients are able to tolerate pegaspargase. Monitor patients and discontinue rituxan infusion for severe reactions 5. Niosh list of antineoplastic and other hazardous drugs in. Nov 01, 2019 oncaspar activity is expressed in international units. Development of a lyophilized formulation of pegaspargase and. Highlights of prescribing information adequately rehydrate. See full prescribing information for complete boxed warning.
Two of the main disadvantages of the drug are 1 the need for frequent intramuscular injection and 2 a very high rate of allergic reactions. The recommended dose is 25,000 international unitsm. If you have any further questions, ask your doctor, pharmacist or nurse. Pegaspargase oncaspar, a pegylated form of native escherichia. For iv administration, give over a period of 1 to 2 hours in 100 ml of sodium chloride or dextrose injection 5%, through an infusion that is already running. Some leukemic cells are unable to synthesize asparagine due to a lack of asparagine synthetase and are dependent on an exogenous source of asparagine for survival. Oncaspar pegaspargase injection is supplied as a clear, colorless, preservativefree, isotonic sterile solution in phosphatebuffered saline, ph 7.
Mepron is a bright yellow, citrusflavored, oral suspension containing 750 mg of atovaquone per 5 ml. Pharmacodynamics and safety of intravenous pegaspargase during remission induction in adults aged 55 years or younger with. Pegaspargase is also being studied in the treatment of other types of cancer. This solution is readytouse and may be administered directly to the patient without further preparation. Oral absorption denaturation and peptidase digestion within. Information for the user oncaspar 750 uml solution. Pegaspargase is a safe, effective alternative to lasparaginase in patients who have had clinical hypersensitivity reactions to both escherichia coliand erwinia carotovorademed lasparaginase.
Oncaspar pegaspargase injection, for intramuscular or intravenous use. The chemotherapy agent lasparaginase has been an important part of acute lymphoblastic leukemia therapy for over 30 years. Oncaspar, innpegaspargase european medicines agency. Firstline acute lymphoblastic leukemia all all and hypersensitivity to native forms of lasparaginase. Pegaspargase is an enzyme that interferes with natural substances necessary for cancer cell growth. Pegaspargase is also used with other chemotherapy drugs to treat a certain type of all in people who have had some types of allergic reactions to medications similar to pegaspargase such as asparaginase elspar. Oncaspar contains pegaspargase, which is an enzyme asparaginase that breaks down asparagine, an important building block of proteins without which cells. Oncaspar is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of patients with all and hyper sensitivity to native forms of lasparaginase. Pdf asparaginaseassociated toxicity in children with. The nccn compendium is a derivative work of the nccn guidelines. Palifermin concentrations declined in the first 30 minutes after dosing. Read all of this leaflet carefully before you are given this medicine because it contains important information for you. Pegaspargase can interfere with metabolism and clearance of other medicinal products, based on its effects on protein synthesis and hepatic function, as well as from its combined use with.
Oncaspar pegaspargaseinjection, for intramuscular or intravenous use initial u. Fda accepts shires biologics license application for. Pegasys peginterferon alfa2a injection, for subcutaneous use initial u. The use of pegaspargase and risk of allergic reactions the saudi food and drug authority sfda would like to inform healthcare. Highlights of prescribing information these highlights do not. Pegaspargase pegaspargase is supplied as a sterile solution in type i singleuse vials containing 3,750 international units of lasparaginase per 5 ml solution ndc 5448230101.
Fatal infusionrelated reactions within 24 hours of rituxan infusion. If you have any further questions, ask your doctor. Pegaspargase, sold under the trade name oncaspar, is a medication used in the treatment of acute lymphoblastic leukemia all. Administer hydrocortisone, monitor for escalating signs of shock and discontinue. Jan 23, 2020 the potential pharmacokinetic interaction between palifermin and heparin was evaluated in a singledose study in 27 healthy subjects receiving palifermin 60 mcgkg coadministered with and without therapeutic levels of unfractionated heparin. Administer protonix for delayedrelease oral suspension approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Pegaspargase is a modified version of the enzyme lasparaginase 01 19. A cr rate of 36% and a pr rate of 14% were documented.
Mepron oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia pcp in adults and adolescent s aged years and older who cannot tolerate trimethoprim. Please click here for full prescribing information. C10403 induction c10403 induction is a chemotherapy regimen for acute lymphoid leukemia all. This coadministration resulted in a 5fold increase in palifermin auc and an 80% decrease in the.
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. Highlights of prescribing information these highlights do. If hypersensitivity occurs, e carotovora asparaginase may be tolerated if available. Highlights of prescribing information these highlights do not include all the information needed to use oncaspar safely and effectively.
Aug 18, 2019 cabazitaxel package insert pdf product monograph. Highlights of prescribing information these highlights do not include all the information needed to use oncaspar. Aetna considers pegaspargase oncaspar medically necessary for either of the following. Mepron is supplied in 210ml bottles or 5ml foil pouches. Fdaapproved indications acute lymphoblastic leukemia all. Select a dynamic defense against reinfection and provide post. 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. Pegaspargase, at a dose of 2,500 ium 2, was administered intramuscularly on day 3 of the 4week induction phase and on day 3 of each of two 8week di phases. Dailymed oncaspar pegaspargase injection, solution for. Leukine sargramostim is a recombinant human granulocytemacrophage colony.
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