HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useASPARLAS safely and effectively. See full prescribing informationfor ASPARLAS.
ASPARLAS(calaspargase pegol-mknl) injection, forintravenous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
ASPARLAS is an asparagine specific enzyme indicated as a componentof a multi-agent chemotherapeutic regimen for the treatment of acutelymphoblastic leukemia in pediatric and young adult patients age1 month to 21 years.
DOSAGE AND ADMINISTRATION
•Recommended Dosage: 2,500 units/m2 intravenously no morefrequently than every 21 days.
•See Full Prescribing Information for important details regardingdosing modifications and preparation and administration.
DOSAGE FORMS AND STRENGTHS
Injection: 3,750 units/5mL(750units/mL) in a single-dose vial.
CONTRAINDICATIONS
•History of serious hypersensitivity reactions to pegylatedL-asparaginase.
•History of serious thrombosis during L-asparaginase therapy.
•History of serious pancreatitis related to previous L-asparaginasetreatment.
•History of serious hemorrhagic events during previousL-asparaginase therapy.
•Severe hepatic impairment.
WARNINGS AND PRECAUTIONS
•Hypersensitivity: Observe patients for one hour after administration.Discontinue ASPARLAS in patients with serious hypersensitivityreactions.
•Pancreatitis: Discontinue ASPARLAS in patients with pancreatitis.Monitor blood glucose.
•Thrombosis: Discontinue ASPARLAS for severe or life-threateningthrombosis. Provide anticoagulation therapy as indicated.
•Hemorrhage: Discontinue ASPARLAS for severe or life-threateninghemorrhage. eva luate for etiology and treat.
•Hepatotoxicity: Monitor for toxicity through recovery from cycle.
ADVERSE REACTIONS
The most common (incidence ≥10%) grade > 3 adverse reactions wereelevated transaminase, bilirubin increased, pancreatitis and abnormalclotting studies.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed.
To report SUSPECTED ADVERSE REACTIONS, contact ServierPharmaceuticals LLC at 857-895-4853 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Acute Lymphoblastic Leukemia (ALL)
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Dose Modifications
2.3 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2 Pancreatitis
5.3 Thrombosis
5.4 Hemorrhage
5.5 Hepatotoxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Acute Lymphoblastic Leukemia (ALL)
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PA