ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Pegaspargase: Drug information

Pegaspargase: Drug information
(For additional information see "Pegaspargase: Patient drug information" and see "Pegaspargase: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Oncaspar
Brand Names: Canada
  • Oncaspar
Pharmacologic Category
  • Antineoplastic Agent, Enzyme;
  • Antineoplastic Agent, Miscellaneous
Dosing: Adult

Note: To decrease the risk and severity of infusion and hypersensitivity reactions, premedicate 30 to 60 minutes prior to pegaspargase administration with acetaminophen, an H1 antagonist (eg, diphenhydramine), and an H2 antagonist (eg, famotidine). Consider thromboprophylaxis with low molecular weight heparin (LMWH) during induction and intensification phases of asparaginase therapy, particularly in patients at high risk for venous thromboembolism; withhold LMWH for platelet count <30,000/mm3 (Ref).

Acute lymphoblastic leukemia, as first-line treatment or in patients with hypersensitivity to native asparaginase

Acute lymphoblastic leukemia, as first-line treatment or in patients with hypersensitivity to native asparaginase: IM, IV:

≤21 years of age: 2,500 units/m2 (as part of a multi-agent combination chemotherapy regimen); do not administer more frequently than every 14 days.

>21 years of age: 2,000 units/m2 (as part of a multi-agent combination chemotherapy regimen); do not administer more frequently than every 14 days.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

Hepatic impairment prior to treatment initiation:

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Severe impairment: Use is contraindicated.

Hepatotoxicity during treatment:

Total bilirubin >3 to 10 times ULN: Withhold pegaspargase until total bilirubin levels decrease to ≤1.5 times ULN.

Total bilirubin >10 times ULN: Discontinue pegaspargase and do not make up for missed doses.

The following off-label adjustments have also been recommended (Ref):

ALT/AST >3 to 5 times ULN: Continue therapy.

ALT/AST >5 to 20 times ULN: Delay next dose until transaminases <3 times ULN.

ALT/AST >20 times ULN: Discontinue therapy if it takes longer than 1 week for transaminases to return to <3 times ULN.

Direct bilirubin <3 mg/dL: Continue therapy.

Direct bilirubin 3.1 to 5 mg/dL: Hold pegaspargase and resume when direct bilirubin <2 mg/dL; consider switching to alternate asparaginase product.

Direct bilirubin >5 mg/dL: Discontinue pegaspargase; do not substitute other asparaginase products; do not make up for missed doses.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status. If dose reduction for toxicity is recommended in the prescribing information, the dose should be increased back to the initial or previously tolerated dose only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

Hemorrhage: Grade 3 or 4: Withhold pegaspargase. Evaluate for coagulopathy and consider clotting factor replacement as needed. Resume pegaspargase with the next scheduled dose if bleeding is controlled. Discontinue pegaspargase for severe or life-threatening hemorrhage.

Hypersensitivity or infusion reaction:

Grade 1: Reduce the infusion rate by 50%.

Grade 2: Interrupt infusion and manage symptoms; when symptoms resolve, resume the infusion with the infusion rate decreased by 50%.

Grade 3 or 4: Permanently discontinue pegaspargase.

Pancreatitis: Grade 3 or 4: Withhold pegaspargase for lipase or amylase elevations >3 times ULN until enzyme levels stabilize or are declining. Withhold pegaspargase for suspected pancreatitis. Discontinue pegaspargase permanently if clinical pancreatitis is confirmed.

Thromboembolism:

Uncomplicated deep vein thrombosis: Withhold pegaspargase and treat with appropriate antithrombotic therapy. Upon resolution of symptoms, consider resuming pegaspargase while continuing antithrombotic therapy.

Severe or life-threatening thrombosis: Discontinue pegaspargase permanently and treat with appropriate antithrombotic therapy.

For acute management of venous thromboembolism (VTE), consider low molecular weight heparin if severe thrombocytopenia (platelets <50,000/mm3) is anticipated; following resolution of severe thrombocytopenia, consider direct oral anticoagulants in the absence of relevant contraindications. For life-threatening VTE (eg, central venous thrombosis or central pulmonary embolism), consider short-term concurrent use of antithrombin concentrate until clinically stable and therapeutic anticoagulation is established. Antithrombin concentrate is suggested for antithrombin levels below 50% to 60%, with a suggested repletion target of 80% to 120%. Temporarily withhold asparaginase therapy for high-risk events (eg, central venous/sinus thrombosis, central pulmonary embolism, proximal deep vein thrombosis, arterial thrombosis); resume after thrombotic event is stabilized (Ref).

The following off-label adjustments have also been recommended (Ref):

Hyperammonemia-related fatigue: Continue therapy for grade 2 toxicity. If grade 3 toxicity occurs, reduce dose by 25%; resume full dose when toxicity ≤ grade 2 (make up for missed doses). If grade 4 toxicity occurs, reduce dose by 50%; resume full dose when toxicity ≤ grade 2 (make up for missed doses).

Hyperglycemia: Continue therapy for uncomplicated hyperglycemia. If hyperglycemia requires insulin therapy, hold pegaspargase (and any concomitant corticosteroids) until blood glucose controlled; resume dosing at prior dose level. For life-threatening hyperglycemia or toxicity requiring urgent intervention, hold pegaspargase (and corticosteroids) until blood glucose is controlled with insulin; resume pegaspargase and do not make up for missed doses.

Hypersensitivity reactions: May continue dosing for urticaria without bronchospasm, hypotension, edema, or need for parenteral intervention. If wheezing or other symptomatic bronchospasm with or without urticaria, angioedema, hypotension, and/or life-threatening hypersensitivity reactions occur, discontinue pegaspargase. Replace pegaspargase with asparaginase (Erwinia).

Hypertriglyceridemia: If serum triglyceride level <1,000 mg/dL, continue pegaspargase but monitor closely for pancreatitis. If triglyceride level >1,000 mg/dL, hold pegaspargase and monitor; resume therapy at prior dose level after triglyceride level returns to baseline.

Pancreatitis:

Asymptomatic amylase or lipase >3 times ULN (chemical pancreatitis) or radiologic abnormalities only: Continue pegaspargase and monitor closely for rising amylase and/or lipase levels or for development of symptomatic pancreatitis.

Clinical pancreatitis (abdominal pain with amylase or lipase >3 times ULN for >3 days and/or development of pancreatic pseudocyst): Permanently discontinue pegaspargase.

Thrombosis and bleeding, CNS:

Thrombosis: Continue therapy for abnormal laboratory findings without a clinical correlate. If grade 3 toxicity occurs, discontinue therapy; if CNS signs/symptoms are fully resolved and further pegaspargase doses are required, may resume therapy at a lower dose and/or longer intervals between doses. Discontinue therapy for grade 4 toxicity.

Hemorrhage: Discontinue therapy; do not withhold therapy for abnormal laboratory findings without a clinical correlate. If grade 3 toxicity occurs, discontinue therapy; if CNS signs/symptoms are fully resolved and further pegaspargase doses are required, may resume therapy at a lower dose and/or longer intervals between doses. Discontinue therapy for grade 4 toxicity.

Thrombosis and bleeding, non-CNS:

Thrombosis: Continue therapy for abnormal laboratory findings without a clinical correlate. If grade 3 or 4 toxicity occurs, withhold therapy until acute toxicity and clinical signs resolve and anticoagulant therapy is stable or completed. Do not withhold therapy for abnormal laboratory findings without clinical correlate.

Hemorrhage: If grade 2 bleeding in conjunction with hypofibrinogenemia occurs, withhold therapy until bleeding ≤ grade 1. Do not withhold therapy for abnormal laboratory findings without clinical correlate. For grade 3 or 4 bleeding, withhold therapy until bleeding ≤ grade 1 and until acute toxicity and clinical signs resolve and coagulant replacement therapy is stable or completed.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Pegaspargase: Pediatric drug information")

Acute lymphoblastic leukemia

Acute lymphoblastic leukemia (ALL): Infants, Children, and Adolescents: IM, IV: 2,500 units/m2/dose (as part of a combination chemotherapy regimen); do not administer more frequently than every 14 days

Dosing adjustment for toxicity: Infants, Children, and Adolescents:

Hemorrhage: Grade 3 or 4: Hold therapy, evaluate for coagulopathy, and consider clotting factor replacement as needed; if resolution (ie, bleeding controlled), resume therapy with the next scheduled dose

Hypersensitivity or infusion reactions:

Grade 1: Reduce infusion rate by 50%

Grade 2: Interrupt infusion and treat symptoms; after resolution of symptoms, resume infusion at 50% of previous rate

Grade 3 or 4: Discontinue permanently

Pancreatitis: Grade 3 or 4: If lipase or amylase >3 times ULN, hold therapy until enzyme levels stabilize or are declining. Discontinue permanently if clinical pancreatitis confirmed.

Thromboembolism:

Uncomplicated deep vein thrombosis (DVT): Hold therapy, evaluate and treat DVT with antithrombotic therapy; upon resolution of symptoms, may resume therapy with concomitant antithrombotic agent(s)

Severe or life-threatening thrombosis: Discontinue permanently; treat thrombosis with necessary medical management

The following additional adjustments have been recommended for other asparaginase products (Ref): Older Adolescents:

Hyperammonemia-related fatigue: Continue therapy for grade 2 toxicity. If grade 3 toxicity occurs, reduce dose by 25%; resume full dose when toxicity ≤ grade 2 (make up for missed doses). If grade 4 toxicity occurs, reduce dose by 50%; resume full dose when toxicity ≤ grade 2 (make up for missed doses).

Hyperglycemia: Continue therapy for uncomplicated hyperglycemia. If hyperglycemia requires insulin therapy, hold the asparaginase product (and any concomitant corticosteroids) until blood glucose controlled; resume dosing at prior dose level. For life-threatening hyperglycemia or toxicity requiring urgent intervention, hold the asparaginase product (and corticosteroids) until blood glucose is controlled with insulin; resume the asparaginase product and do not make up for missed doses.

Hypertriglyceridemia: If serum triglyceride level <1 g/dL, continue the asparaginase product but monitor closely for pancreatitis. If triglyceride level >1 g/dL, hold the asparaginase product and monitor; resume therapy at prior dose level after triglyceride level returns to baseline.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

Infants, Children, and Adolescents:

Baseline (prior to therapy initiation):

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied)

Severe impairment: Use is contraindicated

Hepatotoxicity during therapy:

Total bilirubin >3 to 10 times ULN: Hold therapy until total bilirubin decreases to ≤1.5 times ULN

Total bilirubin >10 times ULN: Discontinue therapy and do not make up for missed doses

The following adjustments have also been recommended for other asparaginase products (Ref): Older adolescents:

ALT/AST >3 to 5 times ULN: Continue therapy.

ALT/AST >5 to 20 times ULN: Delay next dose until transaminases <3 times ULN.

ALT/AST >20 times ULN: Discontinue therapy if it takes longer than 1 week for transaminases to return to <3 times ULN.

Direct bilirubin <3 mg/dL: Continue therapy.

Direct bilirubin 3.1 to 5 mg/dL: Hold pegaspargase and resume when direct bilirubin <2 mg/dL; consider switching to alternate asparaginase product.

Direct bilirubin >5 mg/dL: Discontinue pegaspargase; do not substitute other asparaginase products; do not make up for missed doses.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for pediatric patients.

>10%:

Hypersensitivity: Hypersensitivity reaction (first-line treatment of acute lymphoblastic leukemia [ALL]: 2% to 3%; relapsed ALL with no prior asparaginase hypersensitivity: 10%; relapsed ALL with prior asparaginase hypersensitivity: 32%)

Immunologic: Antibody development (induction: 2%; delayed intensification: 10% to 11%)

1% to 10%:

Cardiovascular: Thromboembolic complications (grades 3/4)

Endocrine & metabolic: Hyperglycemia (grades 3/4: 5%), hypertriglyceridemia (grades 3/4), hypoalbuminemia (grades 3/4)

Gastrointestinal: Pancreatitis (grades 3/4: 2%)

Hematologic & oncologic: Disorder of hemostatic components of blood (grades 3/4: 2%; includes prolonged prothrombin time, partial thromboplastin time, or decreased serum fibrinogen), febrile neutropenia (grades 3/4)

Hepatic: Hyperbilirubinemia (grades 3/4: 2%), increased serum alanine aminotransferase (grades 3/4: ≤3%), increased serum aspartate aminotransferase (grades 3/4: ≤3%)

Infection: Infection (grades 3/4: 5%), sepsis (grades 3/4)

Nervous system: Cerebral thrombosis (grades 3/4: 3%)

Postmarketing (all populations):

Cardiovascular: Thrombosis (including sagittal sinus thrombosis)

Endocrine & metabolic: Hyperammonemia, increased serum cholesterol

Gastrointestinal: Hemorrhagic pancreatitis, necrotizing pancreatitis

Hematologic & oncologic: Hemorrhage

Hepatic: Hepatic impairment

Hypersensitivity: Anaphylactic shock

Nervous system: Intracranial hemorrhage

Neuromuscular & skeletal: Osteonecrosis

Miscellaneous: Cyst (pancreatic)

Contraindications

History of serious hypersensitivity reactions (including anaphylaxis) to pegaspargase or any component of the formulation; history of serious thrombosis with prior L-asparaginase therapy; history of pancreatitis (including pancreatitis associated with prior L-asparaginase therapy); history of serious hemorrhagic events with prior L-asparaginase therapy; severe hepatic impairment.

Warnings/Precautions

Concerns related to adverse effects:

• Glucose intolerance: Pegaspargase may result in glucose intolerance (was irreversible in some cases).

• Hemorrhage: Increased PT, increased PTT, and hypofibrinogenemia may occur in patients receiving pegaspargase. Severe or symptomatic coagulopathy may require appropriate replacement therapy.

• Hepatotoxicity: Hepatotoxicity and abnormal liver function, including elevations of transaminase and bilirubin (direct and indirect) and reduced serum albumin and fibrinogen may occur with pegaspargase.

• Hypersensitivity: Anaphylaxis and serious hypersensitivity reactions may occur with pegaspargase. The risk of serious hypersensitivity reactions is increased in patients with known hypersensitivity to E. coli derived L-asparaginase products. Hypersensitivity reactions may include angioedema, lip swelling, eye swelling, hypotension, bronchospasm, dyspnea, erythema, pruritus, and rash. Premedicate 30 to 60 minutes prior to pegaspargase administration. Observe patients for 1 hour after administration; equipment and immediate treatment for hypersensitivity reactions (eg, epinephrine, oxygen, intravenous steroids, antihistamines) should be available during administration. Discontinue pegaspargase in patients with serious hypersensitivity reactions.

• Pancreatitis: Pancreatitis may occur in patients receiving pegaspargase; hemorrhagic or necrotizing pancreatitis have been reported (sometimes fatal). Avoid alcohol use (Stock 2011). Inform patients of the signs/symptoms of pancreatitis. Untreated pancreatitis may be fatal.

• Thrombotic events: Serious thrombotic events, including sagittal sinus thrombosis may occur with pegaspargase.

Other warnings/precautions:

• Administration route: In a study comparing IV pegaspargase to IM native E. coli asparaginase for post-induction treatment in children with ALL, 5-year disease-free survival did not differ and the overall frequency of asparaginase-related toxicities (including allergy, pancreatitis, and thrombotic or bleeding complications) did not differ between the IV pegaspargase and IM native E. coli asparaginase groups. The median nadir serum asparaginase activity was significantly higher in the IV pegaspargase group. Reported treatment-related anxiety was significantly lower (for both patients and guardians) in the group that received IV pegaspargase (Place 2015).

• Medication error prevention: Do not interchange pegaspargase for asparaginase (E. coli), asparaginase (Erwinia), asparaginase (Erwinia [recombinant]), or calaspargase pegol-mknl; ensure the proper asparaginase formulation, route of administration, and dose prior to administration.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection [preservative free]:

Oncaspar: 750 units/mL (5 mL)

Generic Equivalent Available: US

No

Pricing: US

Solution (Oncaspar Injection)

750 units/mL (per mL): $6,129.18

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Oncaspar: 750 units/mL (5 mL)

Administration: Adult

Have available appropriate agents for maintenance of an adequate airway and treatment of a hypersensitivity reaction (antihistamine, epinephrine, oxygen, IV corticosteroids). Be prepared to treat anaphylaxis at each administration.

IM: Must only be administered as a deep IM injection into a large muscle. Limit the injection volume to 2 mL per single injection site; use multiple injection sites for IM injection volume >2 mL.

IV: Administer over 1 to 2 hours through a running IV infusion line (of either NS or D5W, depending on which fluid was used in preparation of the diluted solution); do not administer IV push. Do not infuse other medications through the same IV line during pegaspargase administration.

Administration: Pediatric

Note : Have available appropriate agents for maintenance of an adequate airway and treatment of a hypersensitivity reaction (antihistamine, epinephrine, oxygen, IV corticosteroids). Be prepared to treat anaphylaxis at each administration.

Parenteral:

IM: Administer as a deep IM injection into a large muscle. Limit the volume at a single injection site to 2 mL; for IM administration, if the volume to be administered is >2 mL, use multiple injection sites.

IV: Administer dose as an IV infusion over a period of 1 to 2 hours through a running IV infusion line (of either NS or D5W, depending on which fluid was used in preparation of the diluted solution). Do not administer IV push. Use of a 0.2 micron filter may result in some loss of potency. Do not infuse other medications through the same IV line during pegaspargase administration.

Use: Labeled Indications

Acute lymphoblastic leukemia and hypersensitivity to asparaginase: Treatment of acute lymphoblastic leukemia (ALL) in pediatric and adult patients with hypersensitivity to native forms of L-asparaginase (as a component of a multiagent chemotherapy regimen)

Acute lymphoblastic leukemia, first-line treatment: First-line treatment of ALL (as a component of a multiagent chemotherapy regimen) in pediatric and adult patients

Medication Safety Issues
Sound-alike/look-alike issues:

Oncaspar may be confused with Asparlas, Elspar

Pegaspargase may be confused with asparaginase (E. coli), asparaginase (Erwinia), asparaginase (Erwinia [recombinant]), calaspargase pegol-mknl, peginesatide

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Hormonal Contraceptives: May enhance the thrombogenic effect of Asparaginase Products. Management: Consider discontinuing hormonal contraceptives and using an alternative contraceptive method in patients treated with asparaginase products. Risk D: Consider therapy modification

Pegloticase: May diminish the therapeutic effect of PEGylated Drug Products. Risk C: Monitor therapy

Pegvaliase: PEGylated Drug Products may enhance the adverse/toxic effect of Pegvaliase. Specifically, the risk of anaphylaxis or hypersensitivity reactions may be increased. Risk C: Monitor therapy

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who may become pregnant. Effective nonhormonal contraception should be used during therapy and for 3 months after the last pegaspargase dose. Hormonal contraceptives may not be effective and are not recommended as a form of contraception.

Pregnancy Considerations

Based on animal reproduction studies conducted with L-asparaginase, adverse effects to the fetus may be expected if exposure occurs during pregnancy.

Breastfeeding Considerations

It is not known if pegaspargase is present in breast milk.

Due to the potential for adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 1 month after the last pegaspargase dose.

Monitoring Parameters

CBC with differential, platelets (at least weekly during treatment); amylase/lipase to confirm early signs of pancreatic inflammation; LFTs (bilirubin, transaminases; baseline and at least weekly during treatment; continue monitoring for at least 6 weeks after the last pegaspargase dose), renal function tests; urine glucose, blood glucose (at least weekly during treatment); triglycerides; uric acid. Evaluate pregnancy status (prior to treatment in patients who may become pregnant). Evaluate coagulation parameters (fibrinogen, PT, PTT [baseline and periodically during and after treatment and in patients with signs/symptoms of hemorrhage]). Consider monitoring antithrombin III activity (Barreto 2017); consider weekly antithrombin levels during the course of asparaginase therapy (ISTH [Zwicker 2020]). Monitor vital signs during administration; monitor for onset of abdominal pain; observe for allergic reaction (for 1 hour after administration); monitor for signs/symptoms of thrombosis or bleeding.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Pegaspargase is a modified version of L-asparaginase, conjugated with monomethoxypolyethylene glycol (mPEG). In leukemic cells, asparaginase hydrolyzes L-asparagine to ammonia and L-aspartic acid, leading to depletion of asparagine. Leukemia cells require exogenous asparagine; normal cells can synthesize asparagine. Asparagine depletion in leukemic cells leads to inhibition of protein synthesis and apoptosis.

Pharmacokinetics (Adult Data Unless Noted)

Onset: Mean maximum asparaginase activity: IM: On day 5 (following a single IM dose of 2,500 units/m2)

Duration: Asparagine depletion: IV (in asparaginase naive adults): 2 to 4 weeks (Douer 2007); IM: ~21 days.

Bioavailability: IM: 82% (first dose); 98% (repeat dosing).

Distribution: Vdss: 1.86 L/m2 (following a single IM dose of 2,500 units/m2); ~2 L (following a single IV dose of 2,500 units/m2); Asparaginase-naive adults: IV: 2.4 L/m2 (Douer 2007).

Metabolism: Systemically degraded.

Half-life elimination: ~5.8 days (following a single IM dose of 2,500 units/m2); ~5.3 days (following a single IV dose of 2,500 units/m2); Asparaginase-naive adults: IV: 7 days (Douer 2007).

Excretion: Clearance: 0.17 L/m2/day (following a single IM dose of 2,500 units/m2); 0.2 L/day (following a single IV dose of 2,500 units/m2).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Oncaspar;
  • (AR) Argentina: Oncaspar;
  • (AT) Austria: Oncaspar;
  • (BE) Belgium: Oncaspar;
  • (BG) Bulgaria: Oncaspar;
  • (BR) Brazil: Oncaspar;
  • (CH) Switzerland: Oncaspar;
  • (CO) Colombia: Oncaspar;
  • (CZ) Czech Republic: Oncaspar;
  • (DE) Germany: Oncaspar;
  • (EE) Estonia: Hamsyl | Oncaspar | Peg l aspatero | Peg l-aspatero;
  • (EG) Egypt: Hamsyl | Oncaspar;
  • (ES) Spain: Oncaspar;
  • (FI) Finland: Oncaspar;
  • (FR) France: Oncaspar;
  • (GB) United Kingdom: Oncaspar;
  • (GR) Greece: Oncaspar;
  • (HR) Croatia: Oncaspar;
  • (HU) Hungary: Oncaspar;
  • (IE) Ireland: Oncaspar;
  • (IN) India: Hamsyl | Peg l aspatero | Pegapar;
  • (IT) Italy: Oncaspar;
  • (KW) Kuwait: Oncaspar;
  • (LB) Lebanon: Oncaspar;
  • (LT) Lithuania: Oncaspar;
  • (LV) Latvia: Oncaspar;
  • (MX) Mexico: Oncaspar;
  • (MY) Malaysia: Oncaspar;
  • (NL) Netherlands: Oncaspar;
  • (NO) Norway: Oncaspar;
  • (NZ) New Zealand: Oncaspar;
  • (PE) Peru: Hb pegaspargase;
  • (PL) Poland: Oncaspar;
  • (PR) Puerto Rico: Oncaspar;
  • (PT) Portugal: Oncaspar;
  • (RU) Russian Federation: Oncaspar;
  • (SA) Saudi Arabia: Oncaspar;
  • (SE) Sweden: Oncaspar;
  • (SI) Slovenia: Oncaspar;
  • (SK) Slovakia: Oncaspar;
  • (UA) Ukraine: Oncaspar
  1. Asselin BL, Whitin JC, Cappola DJ, et al, “Comparative Pharmacokinetic Studies of Three Asparaginase Preparations,” J Clin Oncol, 1993, 11(9):1780-6. [PubMed 8355045]
  2. Avramis VI and Panosyan EH, "Pharmacokinetic/Pharmacodynamic Relationships of Asparaginase Formulations: The Past, the Present and Recommendations for the Future," Clin Pharmacokinet, 2005, 44(4):367-93. [PubMed 15828851]
  3. Avramis VI, Sencer S, Periclou AP, et al, "A Randomized Comparison of Native Escherichia coli Asparaginase and Polyethylene Glycol Conjugated Asparaginase for Treatment of Children With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia: A Children's Cancer Group Study," Blood, 2002, 99(6):1986-94. [PubMed 11877270]
  4. Avramis VI, Spence SA. Clinical pharmacology of asparaginases in the United States: asparaginase population pharmacokinetic and pharmacodynamic (PK-PD) models (NONMEM) in adult and pediatric ALL patients. J Pediatr Hematol Oncol. 2007;29(4):239-247. doi: 10.1097/MPH.0b013e318047b79d. [PubMed 17414566]
  5. Barreto JN, McCullough KB, Peskey CS, et al. Safety and feasibility of lower antithrombin replacement targets in adult patients with hematological malignancies receiving asparaginase therapy. Leuk Lymphoma. 2017;58(11):2588-2597. doi: 10.1080/10428194.2017.1312384. [PubMed 28482728]
  6. Capizzi RL, “Asparaginase Revisited,” Leuk Lymphoma, 1993, 10(Suppl):147-50. [PubMed 8481663]
  7. Douer D, Yampolsky H, Cohen LJ, et al. Pharmacodynamics and safety of intravenous pegaspargase during remission induction in adults aged 55 years or younger with newly diagnosed acute lymphoblastic leukemia. Blood. 2007;109(7):2744-2750. doi: 10.1182/blood-2006-07-035006. [PubMed 17132721]
  8. Farge D, Debourdeau P, Beckers M, et al. International clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer. J Thromb Haemost. 2013;11(1):56-70. [PubMed 23217107]
  9. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
  10. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  11. Jarrar M, Gaynon PS, Periclou AP, et al, "Asparagine Depletion After Pegylated E. coli Asparaginase Treatment and Induction Outcome in Children With Acute Lymphoblastic Leukemia in First Bone Marrow Relapse: A Children's Oncology Group Study (CCG-1941)," Pediatr Blood Cancer, 2006, 47(2):141-6. [PubMed 16425271]
  12. Oncaspar (pegaspargase) [prescribing information]. Boston, MA: Servier Pharmaceuticals LLC; November 2021.
  13. Oncaspar (pegaspargase) [prescribing information]. Boston, MA: Servier Pharmaceuticals LLC; December 2022.
  14. Place AE, Stevenson KE, Vrooman LM, et al. Intravenous pegylated asparaginase versus intramuscular native Escherichia coli L-asparaginase in newly diagnosed childhood acute lymphoblastic leukaemia (DFCI 05-001): a randomised, open-label phase 3 trial. Lancet Oncol. 2015;16(16):1677-1690. [PubMed 26549586] 10.1016/S1470-2045(15)00363-0
  15. Stock W, Douer D, DeAngelo DJ, et al. Prevention and management of asparaginase/pegasparaginase-associated toxicities in adults and older adolescents: recommendations of an expert panel. Leuk Lymphoma. 2011;52(12):2237-2253. [PubMed 21827361]
  16. Zwicker JI, Wang TF, DeAngelo DJ, et al. The prevention and management of asparaginase-related venous thromboembolism in adults: guidance from the SSC on hemostasis and malignancy of the ISTH. J Thromb Haemost. 2020;18(2):278-284. doi:10.1111/jth.14671 [PubMed 31999063]
Topic 9745 Version 204.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟