ONCASPAR Dosage & Rx Info | Uses, Side Effects

Oncaspar

— THERAPEUTIC CATEGORIES —

Leukemias, lymphomas, and other hematologic cancers

Oncaspar Generic Name & Formulations

Legal Class

General Description

Pegaspargase 750 IU/mL; soln for IV or IM inj; 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 Oncaspar is thought to be based on selective killing of leukemic cells due to depletion of plasma L-asparagine.

Oncaspar Indications

Indications

First-line acute lymphoblastic leukemia (including patients with asparaginase hypersensitivity), as part of a multi-agent chemotherapy regimen.

Oncaspar Dosage and Administration

Adults and Children

Premedicate with APAP, diphenhydramine, and famotidine 30–60mins prior to initiation. Give by IV inj over 1–2hrs or by IM inj (max 2mL/inj site). Treat every 14 days. ≤21yrs: 2500 IU/m². >21yrs: 2000 IU/m². Dose modifications: see full labeling.

Oncaspar Contraindications

Contraindications

History of pancreatitis, serious hemorrhage, or thrombosis with prior L-asparaginase therapy. Severe hepatic impairment.

Oncaspar Boxed Warnings

Not Applicable

Oncaspar Warnings/Precautions

Warnings/Precautions

Observe patients for 1hr post-dose. Have medical treatment for anaphylaxis readily available. Permanently discontinue for Grade 3/4 infusion/hypersensitivity reactions, confirmed pancreatitis, or severe thrombosis. Discontinue if severe hemorrhage or liver toxicity occurs. Severe hepatic impairment: not recommended. Monitor bilirubin and transaminases prior to each dose and at least weekly during treatment cycles through at least 6wks after last dose. Monitor frequently for hepatic veno-occlusive disease (VOD). Monitor serum glucose, coagulation parameters. Advise females of reproductive potential to use effective non-hormonal contraception during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after last dose).

Oncaspar Pharmacokinetics

Absorption

Relative bioavailability: 82% following the first IM dose and 98% following repeat dosing.

Distribution

Volume of distribution: 1.86 L/m² (IM inj); ~2 L (IV infusion).

Elimination

Half-life: 5.8 days (IM inj); 5.3 days (IV infusion). Clearance: 0.17 L/m²/day (IM inj); 0.2 L/day (IV infusion).

Oncaspar Interactions

Interactions

May increase the risk of glucocorticoid-induced toxicities.

Oncaspar Adverse Reactions

Adverse Reactions

Hypoalbuminemia, elevated transaminases/bilirubin, febrile neutropenia, hypertriglyceridemia, hyperglycemia, pancreatitis, coagulopathy, embolic/thrombotic events, hypersensitivity.

Oncaspar Clinical Trials

See Literature

Oncaspar Note