Pegaspargase

What it is and how it works

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 the killing of leukemic cells due to depletion of plasma asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine, and therefore depend on an exogenous source of asparagine for survival.

Indications

is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia Acute lymphoblastic leukemia and hypersensitivity to asparaginase First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.

Dosage and administration (summary)

Administered intramuscularly or intravenously no more frequently than every 14 days. Patients ages 21 years and younger: 2,500 International Units/m 2 . Patients ages over 21 years: 2,000 International Units/m 2 . For intramuscular administration, limit the volume at a single injection site to 2 mL; if greater than 2 mL, use multiple injection sites. For intravenous administration, give over a period of 1 to 2 hours in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP through an infusion that is already running. Do not administer ONCASPAR if drug has been frozen, stored at room temperature for more than 48 hours, or shaken or vigorously agitated.

Contraindications

is contraindicated in patients with a: History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients . History of serious thrombosis with prior L-asparaginase therapy . History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy . History of serious hemorrhagic events with prior L-asparaginase therapy . Severe hepatic impairment . History of serious hypersensitivity reactions to ONCASPAR.

Warnings and precautions

Anaphylaxis or serious hypersensitivity reactions : Observe patients for 1 hour after administration. Discontinue ONCASPAR in patients with serious hypersensitivity reactions. Thrombosis : Discontinue ONCASPAR in patients with serious thrombotic events. Pancreatitis : Evaluate patients with abdominal pain for pancreatitis. Discontinue ONCASPAR in patients with pancreatitis. Glucose intolerance : Monitor serum glucose. Hemorrhage : Discontinue ONCASPAR for severe or life-threatening hemorrhage. Evaluate for etiology and treat.

Pregnancy

Pregnancy Risk summary Based on published literature studies with L-asparaginase in pregnant animals, ONCASPAR can cause fetal harm when administered to a pregnant woman. There are no available data on ONCASPAR use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Storage and supply

Store ONCASPAR refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze product . Unopened vials may be stored at room temperature (15°C to 25°C [59°F to 77°F]) for no more than 48 hours.

Source: Pegaspargase (Oncaspar) — US FDA prescribing information, 2024-10-07, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.