Pegaspargase

L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of ONCASPAR is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine.

• ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.ICD-10: C95.90

• ONCASPAR is contraindicated in patients with a: History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients [see Warnings and Precautions (5.1) ] . History of serious thrombosis with prior L-asparaginase therapy [see Warnings and Precautions (5.2) ] .contraindicated

Administered intramuscularly or intravenously no more frequently than every 14 days. ( 2.1 ) Patients ages 21 years and younger: 2,500 International Units/m 2 . ( 2.1 ) Patients ages over 21 years: 2,000 International Units/m 2 . ( 2.1 ) For intramuscular administration, limit the volume at a single injection site to 2 mL; if greater than 2 mL, use multiple injection sites. ( 2.3 ) For intravenous administration, give over a period of 1 to 2 hours in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP through an infusion that is already running. ( 2.3 ) Do not administer ONCASPAR if drug has been frozen, stored at room temperature for more than 48 hours, or shaken or vigorously agitated. ( 16 ) 2.1 Recommended Dosage Patients 21 Years of Age or Younger The recommended dose of ONCASPAR for patients up to and including 21 years of age is 2,500 International Units/m 2 intramuscularly or intravenously no more frequently than every 14 days. Patients More Than 21 Years of Age The recommended dose of ONCASPAR for adult patients more than 21 years of age is 2,000 International Units/m 2 intramuscularly or intravenously no more frequently than every 14 days. 2.2 Recommended Premedication Premedicate patients with acetaminophen, an H-1 receptor blocker (such as diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes prior to administration of ONCASPAR to decrease the risk and severity of both infusion and hypersensitivity reactions [see Warnings and Precautions (5.1) ] .

Anaphylaxis or serious hypersensitivity reactions : Observe patients for 1 hour after administration. Discontinue ONCASPAR in patients with serious hypersensitivity reactions. ( 5.1 ) Thrombosis : Discontinue ONCASPAR in patients with serious thrombotic events. ( 5.2 ) Pancreatitis : Evaluate patients with abdominal pain for pancreatitis. Discontinue ONCASPAR in patients with pancreatitis. ( 5.3 ) Glucose intolerance : Monitor serum glucose. ( 5.4 ) Hemorrhage : Discontinue ONCASPAR for severe or life-threatening hemorrhage. Evaluate for etiology and treat. ( 5.5 ) Hepatotoxicity, including hepatic veno-occlusive disease (VOD) : Monitor for toxicity through recovery from cycle. Discontinue ONCASPAR for severe liver toxicity. ( 5.6 ) 5.1 Anaphylaxis and Serious Hypersensitivity Reactions Anaphylaxis and serious hypersensitivity reactions can occur in patients receiving ONCASPAR. The risk of serious hypersensitivity reactions is higher in patients with known hypersensitivity to ( E.) coli derived L-asparaginase formulations. Other hypersensitivity reactions can include angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnea, pruritus, and rash [see Adverse Reactions (6.1) ] . Premedicate patients 30-60 minutes prior to administration of ONCASPAR. [see Dosage and Administration (2.2) ] .

The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and serious hypersensitivity reactions [see Warnings and Precautions (5.1) ] Thrombosis [see Warnings and Precautions (5.2) ] Pancreatitis [see Warnings and Precautions (5.3) ] Glucose intolerance [see Warnings and Precautions (5.4) ] Hemorrhage [see Warnings and Precautions (5.5) ] Hepatotoxicity, including VOD [see Warnings and Precautions (5.6) ] The most common (>5%) grade > 3 adverse reactions with ONCASPAR are hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Servier Pharmaceuticals, at 1-800-807-6124 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The most common grade 3 and 4 adverse reactions (>5%) included: hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections.

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk summary Based on published literature studies with L-asparaginase in pregnant animals, ONCASPAR can cause fetal harm when administered to a pregnant woman. There are no available data on ONCASPAR use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring (see Data ) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with ONCASPAR to evaluate its effect on reproduction and fetal development. Published literature studies in which pregnant rabbits were administered L-asparaginase or pregnant rats were deprived of dietary asparagine suggested harm to the animal offspring. 8.2 Lactation Risk summary There are no data on the presence of pegaspargase in human milk, the effects on the breastfed child, or the effects on milk production.

Metabolism

Pharmacokinetic assessments were based on an enzymatic assay measuring asparaginase activity after intramuscular (IM, CCG-1962) and intravenous (IV, AALL07P4) administration of 2,500 International Units/m 2 in patients with ALL. Absorption The mean maximum asparaginase activity (C max ) was reached at approximately 1 IU/mL (n=45-52) on Day 5 after a single IM injection.

Three patients received 10,000 International Units/m 2 of ONCASPAR as an intravenous infusion. One patient experienced a slight increase in liver enzymes. A second patient developed a rash 10 minutes after the start of the infusion, which was controlled with the administration of an antihistamine and by slowing down the infusion rate. A third patient did not experience any adverse reactions. There is no specific antidote for ONCASPAR overdosage. In case of overdose, monitor patients closely for signs and symptoms of adverse reactions, and appropriately manage with symptomatic and supportive treatment.

• Feb 1, 1994BLABLA103411Sigma Tau

1. 1Febrile Neutropenia1,57313%
2. 2Pyrexia7676.4%
3. 3Febrile Bone Marrow Aplasia6765.6%
4. 4Vomiting5975.0%
5. 5Neutropenia5694.7%
6. 6Sepsis5614.7%
7. 7Abdominal Pain5084.2%
8. 8Hypotension4623.8%
9. 9Pancreatitis4113.4%
10. 10Hypertriglyceridaemia4063.4%
11. 11Thrombocytopenia4023.3%
12. 12Nausea4003.3%
13. 13Hyperbilirubinaemia3683.1%
14. 14Pneumonia3603.0%
15. 15Bacterial Infection3392.8%

The 10 most recently updated of 228 ClinicalTrials.gov registrations naming Pegaspargase as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
  Recruiting · Phase 2 · Interventional · 461 enrolled · National Cancer Institute (NCI)
  NCT04546399updated 2026-06-12
• A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
  Recruiting · Phase 2 · Interventional · 100 enrolled · Pfizer
  NCT05748171updated 2026-06-11
• Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
  Recruiting · Phase 2 · Interventional · 80 enrolled · Children's Oncology Group
  NCT02981628updated 2026-06-05
• A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
  Recruiting · Phase 2 · Interventional · 222 enrolled · National Cancer Institute (NCI)
  NCT06124157updated 2026-06-03
• TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
  Recruiting · Phase 1 · Phase 2 · Interventional · 90 enrolled · Tanja Andrea Gruber
  NCT05848687updated 2026-06-03
• Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
  Active not recruiting · Phase 3 · Interventional · 847 enrolled · National Cancer Institute (NCI)
  NCT02112916updated 2026-06-03
• Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
  Active not recruiting · Phase 3 · Interventional · 669 enrolled · National Cancer Institute (NCI)
  NCT02101853updated 2026-06-03
• Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
  Active not recruiting · Phase 3 · Interventional · 440 enrolled · Children's Oncology Group
  NCT05602194updated 2026-06-02
• Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
  Recruiting · Phase 3 · Interventional · 310 enrolled · Alliance for Clinical Trials in Oncology
  NCT03150693updated 2026-06-02
• Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
  Completed · Phase 3 · Interventional · 5,949 enrolled · National Cancer Institute (NCI)
  NCT02883049updated 2026-06-02

Frequently asked questions

How does Pegaspargase work?

L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of ONCASPAR is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine.

What is Pegaspargase used for?

According to FDA labeling, Pegaspargase carries indications including: ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pegaspargase?

Pegaspargase is classified as Other antineoplastic agents, Asparagine-specific Enzyme, Enzymatic Activity, Decreased Protein Synthesis.

What are the brand names for Pegaspargase?

Pegaspargase is marketed under brand names including Oncaspar.

What are the contraindications for Pegaspargase?

Pegaspargase labeling lists contraindications including: ONCASPAR is contraindicated in patients with a: History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients [see Warnings and Precautions (5.1) ] . History of serious thrombosis with prior L-asparaginase therapy [see Warnings and Precautions (5.2) ] .. Always consult the full prescribing information and a clinician.