Source: FDA, National Drug Code (US) Revision Year: 2020
ASPARLAS is 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.
The recommended dose of ASPARLAS is 2,500 units/m2 given intravenously no more frequently than every 21 days.
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 lifethreatening
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.
Store ASPARLAS refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze product. Unopened vials may be stored at room temperature (15°C to 25°C [59°F to 77°F]) for no more than 48 hours.
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