Asparlas (calaspargase pegol - mknl)

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.

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

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

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.

• 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.