TIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing informationare not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Acute Lymphoblastic Leukemia
ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatmentof acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dose of ASPARLAS is 2,500 units/m2 given intravenously no more frequently thanevery 21 days.
2.2 Dose Modifications
Monitor patients at least weekly, with bilirubin, transaminases, glucose and clinical examinations untilrecovery from the cycle of therapy. If an adverse reaction should occur, modify treatment according toTable 1.
Table 1. Dose Modifications
Adverse Reaction Severity* Action
Grade 1 • Reduce the infusion rate by 50%
Infusion Reaction or
Hypersensitivity
Reaction
Grade 2 • Interrupt the infusion of ASPARLAS
• Treat the symptoms
• When symptoms resolve, resume the infusionand reduce the infusion rate by 50%Grade 3 to 4 • Discontinue ASPARLAS permanentlyHemorrhage Grade 3 to 4
• Hold ASPARLAS.
• eva luate for coagulopathy and consider clottingfactor replacement as needed.
• Resume ASPARLAS with the next scheduleddose if bleeding is controlled.Pancreatitis Grades 3 to 4
• Hold ASPARLAS for elevations in lipase oramylase >3 times the ULN until enzyme levelsstabilize or are declining
• Discontinue ASPARLAS permanently if clinicalpancreatitis is confirmed.
Thromboembolism
Uncomplicated deep
vein thrombosis
• Hold ASPARLAS.
• Treat with appropriate antithrombotic therapy
• Upon resolution of symptoms consider resumingASPARLAS, while continuing antithrombotictherapy.Severe or lifethreateningthrombosis
• Discontinue ASPARLAS permanently.
• Treat with appropriate antithrombotic therapy.
Hepatotoxicity
Total bilirubin more
than 3 times to no
more than 10 times
the upper limit of
normal
• Hold ASPARLAS until Total bilirubin levels godown to ≤ 1.5 times the upper limit of normal Total bilirubin morethan 10 times the
• Discontinue ASPARLAS and do not make up formissed doses
upper limit of normal
*Grade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening
2.3 Preparation and Administration
ASPARLAS is a clear and colorless solution. Visually inspect parenteral drug products for particulatematter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial. Donot administer if ASPARLAS has been shaken or vigorously agitated, frozen, or stored at room temperaturefor more than 48 hours.
•Dilute ASPARLAS in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection,USP using sterile/aseptic technique. Discard any unused portion left in a vial.
•After dilution, administer immediately into a running infusion of either 0.9% sodium chloride or5% dextrose, respectively.
•Administer the dose over a period of 1 hour.
•Do not infuse other drugs through the same intravenous line during administration ofASPARLAS.
•The diluted solution may be sto |
