Usual Adult Dose for Acute Lymphoblastic Leukemia

18 to 21 years:
2500 international units/m2 IM or IV no more frequently than every 14 days

21 years and older:
2000 international units/m2 IM or IV no more frequently than every 14 days

Comments:

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

Use: Component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) and hypersensitivity to native forms of L-asparaginase

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

1 year and older:
2500 international units/m2 IM or IV no more frequently than every 14 days

Comments:

• IM: Single injection site volume administered should be limited to 2 mL. If volume to be administered is greater than 2 mL, multiple injection sites should be used.
• IV: Give over a period of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through an infusion that is already running.
• Monitor patients at least weekly, with bilirubin, transaminases, glucose. and clinical examinations until recovery from the cycle of therapy.

Use: Component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) and hypersensitivity to native forms of L-asparaginase

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

DOSE ADJUSTMENTS:
INFUSION REACTION/HYPERSENSITIVITY REACTION:

• Grade 1: Reduce the infusion rate by 50%.
• Grade 2: Interrupt infusion and treat symptoms; when symptoms resolve, resume infusion and reduce the rate by 50%.
• Grade 3 or 4: Discontinue therapy permanently.

HEMORRHAGE:

• 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.

PANCREATITIS:

• 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 for confirmed pancreatitis.

THROMBOEMBOLISM:

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

HEPATOTOXICITY:

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

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• History of serious thrombosis during previous asparaginase therapy
• History of pancreatitis (including pancreatitis related to previous therapy with this drug)
• History of serious hemorrhagic events during previous therapy with this drug
• Severe hepatic impairment

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• IM: Single injection site volume administered should be limited to 2 mL. If volume to be administered is greater than 2 mL, multiple injection sites should be used. Use only one dose per vial and discard unused product.
• IV: This drug should be given over a period of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through an infusion that is already running. After the solution is diluted for IV use, the solution should be used immediately.
• Do not administer if drug has been frozen, stored at room temperature 15C to 25C (59F to 77F) for more than 48 hours, shaken or vigorously agitated.

Storage requirements:

• IV: If immediate use is not possible, the diluted solution should be stored at 2C to 8C (36F to 46F). Storage after dilution should not exceed 48 hours from the time of preparation to completion of administration.
• Protect infusion bags from direct sunlight.
• Parenteral drug products should be inspected for particulate matter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial or container.

Frequently asked questions

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