Usual Adult Dose for Acute Lymphoblastic Leukemia

18 to 21 years:
2500 units/m2 IV over 60 minutes no more frequently than every 21 days

Use: This drug indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in adults 18 to 21 years old

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

1 month and older:
2500 units/m2 IV over 60 minutes no more frequently than every 21 days

Use: This drug indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric patients age 1 month and older

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Severe hepatic impairment: Contraindicated

Dose Adjustments

DOSE MODIFICATIONS:
INFUSION REACTION/HYPERSENSITIVITY REACTION:

• Grade 1: Reduce infusion rate by 50%.
• Grade 2: Interrupt infusion; treat symptoms; when symptoms resolve, resume infusion at a 50% reduced rate.
• Grade 3 or 4: Permanently discontinue therapy.

• Grade 3 or 4: Withhold therapy; evaluate for coagulopathy and consider clotting factor replacement as needed; resume therapy with the next scheduled dose if bleeding is controlled.

• Grade 3 or 4: Withhold therapy for elevations in lipase or amylase greater than 3 times the upper limit of normal (ULN) until enzyme levels stabilize or are declining. Discontinue therapy permanently if clinical pancreatitis is confirmed.

• Uncomplicated deep vein thrombosis: Withhold therapy; treat with antithrombotics; when symptoms resolve consider resuming therapy while continuing antithrombotics.
• Severe or life-threatening thrombosis: Discontinue therapy permanently. Treat with antithrombotics.

• Total bilirubin more than 3 x ULN to no more than 10 x ULN: Withhold therapy until total bilirubin levels go down to 1.5 x ULN or less.
• Total bilirubin more than 10 x ULN: Permanently discontinue therapy and do not make up for missed doses.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity (including anaphylaxis) to the active component or any of the ingredients
• History of serious thrombosis during previous L-asparaginase therapy
• History of serious pancreatitis during previous L-asparaginase therapy
• History of serious hemorrhagic events during previous L-asparaginase therapy
• Severe hepatic impairment

Dialysis

Data not available

Other Comments

Storage requirements:

• The diluted solution may be stored for up to 4 hours at room temperature (15C to 25C [59F to 77F]) or refrigerated at 2C to 8C (36F to 46F) for up to 24 hours.
• Protect from light.
• Do not freeze or shake.

• This drug is a clear and colorless solution.
• Visually inspect for particulate matter, cloudiness, or discoloration and discard the vial if any of these are present.
• Do not administer if the vial has been shaken or vigorously agitated, frozen, or stored at room temperature for more than 48 hours.
• Dilute vial in 100 mL of 0.9% sodium chloride injection 5% dextrose injection 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 or 5% dextrose, respectively.
• Administer the dose over a period of 1 hour.
• Do not infuse other drugs through the same IV line.

• Compatible with 0.9% sodium chloride injection or 5% dextrose.

• Monitor patients at least weekly, with bilirubin, transaminases, glucose, and clinical examinations until recovery from the cycle of therapy.

Frequently asked questions

• How does Asparlas (calaspargase pegol-mknl) compare to Oncaspar (pegaspargase)?