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Asparlas Generic Name & Formulations
Legal Class
Rx
General Description
Calaspargase pegol-mknl 750 Units/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Asparagine-specific enzyme.
How Supplied
Single-dose vial (5mL)—1
Manufacturer
Generic Availability
NO
Asparlas Indications
Indications
Treatment of acute lymphoblastic leukemia as a component of a multi-agent chemotherapeutic regimen.
Asparlas Dosage and Administration
Adults and Children
<1month: not established. Premedicate with acetaminophen, H1 receptor blocker (eg, diphenhydramine), and H2 receptor blocker (eg, famotidine) 30–60mins prior to administration. 1month–21yrs: Give by IV infusion over 1hr. 2500 Units/m2 no more frequently than every 21 days. Dose modifications: see full labeling.
Asparlas Contraindications
Contraindications
History of serious thrombosis, pancreatitis, or hemorrhagic events with prior L-asparaginase therapy. Severe hepatic impairment.
Asparlas Boxed Warnings
Not Applicable
Asparlas Warnings/Precautions
Warnings/Precautions
Have resuscitation equipment available and observe patient for 1hr post-dose. Assess serum amylase and/or lipase levels. Discontinue if serious hypersensitivity reactions, thrombotic events, or pancreatitis occur. Evaluate for hemorrhage with coagulation parameters. Evaluate LFTs at least weekly, during and for ≥6 weeks after last dose. Discontinue if serious hepatotoxicity occurs. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective non-hormonal contraception during and for ≥3 months after the last dose. Nursing mothers: not recommended (during and for 3 months after the last dose).
Asparlas Pharmacokinetics
See Literature
Asparlas Interactions
Interactions
Antagonizes hormonal contraceptives.
Asparlas Adverse Reactions
Adverse Reactions
Elevated transaminases, increased bilirubin, pancreatitis, abnormal clotting, diarrhea, hypersensitivity, embolic/thrombotic events, sepsis, dyspnea, hemorrhages.
Asparlas Clinical Trials
See Literature
Asparlas Note
Not Applicable
Asparlas Patient Counseling
See Literature
