Asparlas (calaspargase pegol-mknl) Injection

Product Description

1. Technical Specifications

2. Product Description

Asparlas (calaspargase pegol-mknl) is a long-acting pegylated L-asparaginase engineered with a stabilized linker to extend half-life. It enzymatically depletes circulating L-asparagine, starving leukemic lymphoblasts (which cannot synthesize asparagine) and inhibiting protein synthesis cell death. Used as part of multi-agent chemotherapy regimens for Acute Lymphoblastic Leukemia (ALL).

3. Product Highlights

4. Therapeutic Uses

• ALL (Acute Lymphoblastic Leukemia): In combination with other chemotherapeutic agents; commonly indicated for pediatric and young adult patients who require an asparaginase component in their protocol.

5. Dosage & Administration

• Recommended dose: 2,500 units/m IV given no more frequently than every 3 weeks (q3-week schedule), aligned with its extended half-life.

• Infusion: Dilute in compatible IV fluid and infuse over 1 hour (follow institutional/label procedures for dilution volume, in-line filtration, and infusion rate).

• Premedication: Antihistamine antipyretic corticosteroid per center protocol to reduce infusion/hypersensitivity reactions.

• Dose Modifications / Hold Criteria:

  • Hypersensitivity (grade 2), pancreatitis, thrombosis/hemorrhage, severe hepatotoxicity, or hyperammonemia: hold and manage; permanently discontinue for life-threatening events or as per protocol.

  • Resume only after resolution to acceptable grade and per protocol guidance.
    (Always follow the specific protocol/label being used at your center.)

6. Side Effects

Common:

• Nausea, vomiting, decreased appetite

• Fatigue, pyrexia

• Elevated liver enzymes, hyperbilirubinemia

• Hyperglycemia, hypertriglyceridemia

• Coagulation abnormalities ( fibrinogen, antithrombin), edema

Serious / Severe:

• Hypersensitivity / anaphylaxis (infusion reactions)

• Pancreatitis (can be hemorrhagic/necrotizing)

• Thromboembolism (DVT/PE, CNS thrombosis) and hemorrhage

• Severe hepatotoxicity (cholestasis, hepatic failurerare)

• Hyperammonemia (encephalopathy)

• Severe infections secondary to treatment-related effects

7. Precautions

• Do not use in patients with prior serious hypersensitivity to asparaginase products, history of pancreatitis, or serious thrombosis/hemorrhage with prior asparaginase (per protocol/label).

• Monitoring (baseline and periodic):

  • Liver function: AST/ALT, bilirubin, alkaline phosphatase

  • Pancreas: Amylase, lipase; monitor for abdominal pain

  • Metabolic: Glucose, triglycerides, ammonia

  • Coagulation: PT/INR, aPTT, fibrinogen, antithrombin; replace as indicated

  • Clinical: Infusion reactions, signs of thrombosis/bleeding, infection

• Pregnancy & Lactation: May cause fetal harm; effective contraception required; avoid breastfeeding during therapy and for a period after last dose (per label).

• Drug Interactions: Caution with hepatotoxic agents, anticoagulants/antiplatelets, glucocorticoids, and other agents affecting coagulation or pancreas.

• Administration Setting: Use only in facilities experienced with pediatric/AYA leukemia chemotherapy and capable of managing anaphylaxis, pancreatitis, and coagulopathies.