What is Asparlas (calaspargase pegol - mknl), and how does it work?

Generic drug: calaspargase pegol - mknl

Brand name: Asparlas

Asparlas (calaspargase pegol - mknl) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.

What are the side effects of Asparlas?

Common side effects of Asparlas include:

What is the dosage for Asparlas?

Recommended Dosage

The recommended dose of Asparlas is 2,500 units/m2 given intravenously no more frequently than every 21 days.

Dose Modifications

Monitor patients at least weekly, with bilirubin, transaminases, glucose and clinical examinations until recovery from the cycle of therapy. If an adverse reaction should occur, modify treatment according to Table 1.

Table 1. Dose Modifications

Adverse Reaction Severity* Action
Infusion Reaction or Hypersensitivity Reaction Grade 1
  • Reduce the infusion rate by 50%
Grade 2
  • Interrupt the infusion of Asparlas
  • Treat the symptoms
  • When symptoms resolve, resume the infusion and reduce the infusion rate by 50%
Grade 3 to 4
  • Discontinue Asparlas permanently
Hemorrhage Grade 3 to 4
  • Hold Asparlas.
  • Evaluate for coagulopathy and consider clotting factor replacement as needed.
  • Resume Asparlas with the next scheduled dose if bleeding is controlled.
Pancreatitis Grades 3 to 4
  • Hold Asparlas for elevations in lipase or amylase >3 times the ULN until enzyme levels stabilize or are declining
  • Discontinue Asparlas permanently if clinical pancreatitis is confirmed.
Thromboembolism Uncomplicated deep vein thrombosis
  • Hold Asparlas.
  • Treat with appropriate antithrombotic therapy
  • Upon resolution of symptoms consider resuming Asparlas, while continuing antithrombotic therapy.
Severe or life-threatening thrombosis
  • 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 go down to ≤ 1.5 times the upper limit of normal
Total bilirubin more than 10 times the upper limit of normal
  • Discontinue Asparlas and do not make up for missed doses
*Grade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening

Preparation And Administration

Asparlas is a clear and colorless solution. Visually inspect parenteral drug products for particulate matter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial. Do not administer if Asparlas has been shaken or vigorously agitated, frozen, or stored at room temperature for 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 or 5% dextrose, respectively.
  • Administer the dose over a period of 1 hour.
  • Do not infuse other drugs through the same intravenous line during administration of Asparlas.
  • The diluted solution may be stored for up to 4 hours at room temperature (15°C to 25°C [59°F to 77°F]) or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours.
  • Protect from light. Do not shake or freeze.

What drugs interact with Asparlas?

No Information Provided

Is Asparlas safe to use while pregnant or breastfeeding?

  • There are no available data on Asparlas use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • There are no data on the presence of calaspargase pegol-mknl in human milk, the effects on the breastfed child, or the effects on milk production.
  • Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child, advise lactating women not to breastfeed while receiving Asparlas and for 3 months after the last dose.

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Summary

Asparlas (calaspargase pegol - mknl) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. Common side effects of Asparlas include elevated transaminase, bilirubin increased, pancreatitis, abnormal clotting studies, diarrhea, hypersensitivity, shortness of breath, bleeding, pneumonia, and abnormal heart rate.

Treatment & Diagnosis

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Medically Reviewed on 2/19/2021
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All sections courtesy of the U.S. Food and Drug Administration