Label: ASPARLAS- calaspargase pegol injection, solution

  • NDC Code(s): 72694-515-01
  • Packager: Servier Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated October 8, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ASPARLAS safely and effectively. See full prescribing information for ASPARLAS. ASPARLAS® (calaspargase pegol-mknl) injection, for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - The recommended dose of ASPARLAS is 2,500 units/m2 given intravenously no more frequently than every 21 days. 2.2 Recommended Premedication - Premedicate patients ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injection: 3,750 units/5 mL (750 units/mL) clear, colorless solution in a single-dose vial.
  • 4 CONTRAINDICATIONS
    ASPARLAS is contraindicated in patients with: History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy [see Warnings and Precautions ...
  • 5 WARNINGS AND PRECAUTIONS
    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 ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1)] Pancreatitis [see Warnings and Precautions ...
  • 8 USE IN SPECIFIC POPULATIONS
    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 ...
  • 11 DESCRIPTION
    Calaspargase pegol-mknl contains an asparagine specific enzyme derived from Escherichia coli, as a conjugate of L-asparaginase (L-asparagine amidohydrolase) and monomethoxypolyethylene glycol ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity, mutagenicity, and impairment of fertility studies have not been conducted with calaspargase pegol-mknl.
  • 14 CLINICAL STUDIES
    14.1 Acute Lymphoblastic Leukemia - The determination of efficacy was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    ASPARLAS (calaspargase pegol-mknl) injection is supplied as a clear, colorless, preservative-free sterile solution in a single-dose vial containing 3,750 units of calaspargase pegol-mknl per 5 mL ...
  • 17 PATIENT COUNSELING INFORMATION
    Hypersensitivity - Inform patients on the possibility of serious allergic reactions, including anaphylaxis. Instruct the patient on the symptoms of allergic reactions and to seek medical advice ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Servier Pharmaceuticals LLC - Boston, MA 02210 - U.S. License No. 2125 - ASPARLAS is a registered trademark of Servier IP UK Ltd, a wholly owned, indirect subsidiary of Les Laboratoires ...
  • PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton
    NDC 72694-515-01 - ASPARLAS® calaspargase - pegol-mknl - Injection - 3750 units/5 mL - (750 units/mL) For Intravenous Infusion - Only - One single-dose vial. Discard unused portion. Must dilute before use. Rx ...
  • INGREDIENTS AND APPEARANCE
    Product Information