Calaspargase Pegol

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

• ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.ICD-10: C95.90

• ASPARLAS is contraindicated in patients with: History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy [see Warnings and Precautions (5.1) ] History of serious pancreatitis during previous L-asparaginase therapy [see Warnings and Precautions (5.2) ] History of serious thrombosis during previous L-asparaginase therapy [see Warnings and Precautions (5.3) ] History of serious hemorrhagic events during previous L-asparaginase therapy [see Warnings and Precautions (5.4) ] Severe hepatic impairment [see Warnings and Precautions (5.5) ] History of serious hypersensitivity reactions to pegylated L-asparaginase. ( 4 ) History of serious thrombosis during L-asparaginase therapy.contraindicated

Recommended Dosage: 2,500 units/m 2 intravenously no more frequently than every 21 days. ( 2.1 ) See Full Prescribing Information for important details regarding dosing modifications and preparation and administration. ( 2.2 , 2.3 , 2.4 ) 2.1 Recommended Dosage The recommended dose of ASPARLAS is 2,500 units/m 2 given intravenously no more frequently than every 21 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 ASPARLAS to decrease the risk and severity of both infusion and hypersensitivity reactions [see Warnings and Precautions (5.1) ] . 2.3 Recommended Monitoring and Dosage Modifications for Adverse Reactions Monitor patients at least weekly with bilirubin, transaminases, glucose, and clinical examinations until recovery from the cycle of therapy. If an adverse reaction should occur, modify treatment according to Table 1. Table 1: Dosage Modifications Adverse Reaction Severity Grade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening.

Hypersensitivity : Observe patients for one hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions. ( 5.1 ) Pancreatitis : Discontinue ASPARLAS in patients with pancreatitis. Monitor blood glucose. ( 5.2 ) Thrombosis : Discontinue ASPARLAS for severe or life-threatening thrombosis. ( 5.3 ) Hemorrhage : Discontinue ASPARLAS for severe or life-threatening hemorrhage. Evaluate for etiology and treat. ( 5.4 ) Hepatotoxicity, including hepatic veno-occlusive disease (VOD) : Monitor for toxicity through recovery from cycle. Discontinue ASPARLAS for severe liver toxicity. ( 5.5 ) 5.1 Hypersensitivity Grade 3 and 4 hypersensitivity reactions, including anaphylaxis, have been reported in clinical trials with ASPARLAS with an incidence between 7 and 21% [see Contraindications (4) , Adverse Reactions (6.1) ] . Hypersensitivity reactions observed with other asparaginases 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 ASPARLAS [see Dosage and Administration (2.2) ] . Because of the risk of serious allergic reactions (e.g., life-threatening anaphylaxis), administer ASPARLAS in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines) [see Dosage and Administration (2.4) ] and observe patients for 1 hour after administration.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Thrombosis [see Warnings and Precautions (5.3) ] Hemorrhage [see Warnings and Precautions (5.4) ] Hepatotoxicity, including VOD [see Warnings and Precautions (5.5) ] The most common (incidence ≥10%) grade ≥3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis, and abnormal clotting studies. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Servier Pharmaceuticals LLC 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Study DFCI 11-001 The safety of ASPARLAS was investigated in Study DFCI 11-001, an open-label, randomized, active-controlled multicenter clinical trial that treated 237 children and adolescents with newly diagnosed ALL or lymphoblastic lymphoma, with ASPARLAS 2,500 U/m 2 (n=118) or pegaspargase 2,500 U/m 2 (n=119) as part of a Dana-Farber Cancer Institute (DFCI) ALL Consortium backbone therapy. The median age on enrollment was 5 years (range, 1-20 years). The majority of patients were male (62%) and white (70%). Most patients were considered standard risk (SR, 59%) and had B-cell lineage ALL (87%).

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on published literature studies with L-asparaginase in pregnant animals, ASPARLAS can cause fetal harm when administered to a pregnant woman. There are no available data on ASPARLAS use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes. Published literature studies in pregnant rabbits, however, 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 risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study, calaspargase pegol-mknl was administered intravenously at doses of 75, 150, and 300 U/kg (0.2, 0.6 and 1 times the maximum recommended human dose, respectively, based on AUC) to pregnant rats during the period of organogenesis.

Metabolism

Calaspargase pegol-mknl pharmacokinetics (PK) were assessed through measurement of plasma asparaginase activity via a coupled enzymatic assay. The plasma asparaginase activity pharmacokinetics were characterized in 43 patients (1 to 26 years) with newly diagnosed high risk B-precursor ALL treated with a multidrug backbone therapy.

• Dec 20, 2018BLABLA761102Servier Pharma Llc

1. 1Hypersensitivity19029%
2. 2Anaphylactic Reaction9314%
3. 3Pancreatitis649.6%
4. 4Infusion Related Reaction558.3%
5. 5Hypertriglyceridaemia487.2%
6. 6Febrile Neutropenia345.1%
7. 7Vomiting335.0%
8. 8Neutropenia253.8%
9. 9Tachycardia223.3%
10. 10Nausea213.2%
11. 11Cough203.0%
12. 12Hyperglycaemia192.9%
13. 13Pancytopenia182.7%
14. 14Acute Kidney Injury142.1%
15. 15Hepatotoxicity142.1%

The 10 most recently updated of 29 ClinicalTrials.gov registrations naming Calaspargase Pegol 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
• Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia
  Recruiting · Phase 2 · Interventional · 153 enrolled · National Cancer Institute (NCI)
  NCT06317662updated 2026-06-11
• Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment
  Not yet recruiting · Phase 2 · Interventional · 90 enrolled · SWOG Cancer Research Network
  NCT07636564updated 2026-06-09
• 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
• 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 Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
  Recruiting · Phase 3 · Interventional · 5,951 enrolled · Children's Oncology Group
  NCT03959085updated 2026-05-05
• Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
  Active not recruiting · Phase 3 · Interventional · 475 enrolled · Children's Oncology Group
  NCT03007147updated 2026-05-04
• Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
  Recruiting · Phase 2 · Interventional · 128 enrolled · St. Jude Children's Research Hospital
  NCT06533748updated 2026-05-01
• Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)
  Recruiting · Phase 2 · Interventional · 100 enrolled · St. Jude Children's Research Hospital
  NCT06390319updated 2026-05-01

Frequently asked questions

How does Calaspargase Pegol 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 ASPARLAS is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine.

What is Calaspargase Pegol used for?

According to FDA labeling, Calaspargase Pegol carries indications including: ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Calaspargase Pegol?

Calaspargase Pegol is classified as Other antineoplastic agents, Asparagine-specific Enzyme, Enzyme Interactions, Cellular Proliferation Alteration, Decreased Protein Synthesis, Increased Cellular Death.

What are the brand names for Calaspargase Pegol?

Calaspargase Pegol is marketed under brand names including Asparlas.

What are the contraindications for Calaspargase Pegol?

Calaspargase Pegol labeling lists contraindications including: ASPARLAS is contraindicated in patients with: History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy [see Warnings and Precautions (5.1) ] History of serious pancreatitis during previous L-asparaginase therapy [see Warnings and Precautions (5.2) ] History of serious thrombosis during previous L-asparaginase therapy [see Warnings and Precautions (5.3) ] History of serious hemorrhagic events during previous L-asparaginase therapy [see Warnings and Precautions (5.4) ] Severe hepatic impairment [see Warnings and Precautions (5.5) ] History of serious hypersensitivity reactions to pegylated L-asparaginase. ( 4 ) History of serious thrombosis during L-asparaginase therapy.. Always consult the full prescribing information and a clinician.