ASPARLAS Dosage & Rx Info | Uses, Side Effects

Asparlas

— THERAPEUTIC CATEGORIES —

Leukemias, lymphomas, and other hematologic cancers

Asparlas Generic Name & Formulations

Legal Class

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

Servier Pharmaceuticals, LLC

Generic Availability

Mechanism of Action

L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of Asparlas is thought to be based on selective killing of leukemic cells due to depletion of plasma L-asparagine.

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; 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. Risk for hepatotoxicity, including severe hepatic veno-occlusive disease (may be fatal); monitor frequently. Evaluate LFTs prior to each dose and at least weekly, during and through 6 weeks after the 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

Absorption

T_max: 1.17 hours.

Distribution

Volume of distribution: 2.96 L.

Elimination

Half-life: 16.1 days.

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