Prescription Products - ONCASPAR®

ONCASPAR® (pegaspargase) is the only FDA-approved pegylated formulation of L-asparaginase, the enzyme that depletes the amino acid asparagine. For the last 25 years, L-asparaginase has been an important component in the treatment of acute lymphoblastic leukemia (ALL).1

While normal cells can produce asparagine, leukemic cells are unable to produce enough asparagine to survive on their own. L-asparaginase is given to ALL patients to ensure depletion of asparagine that is circulating in the blood.2 Depletion (starving the leukemic cells) of asparagine ultimately results in leukemic cell death.3

ONCASPAR allows patients to gain the full benefits of asparaginase therapy with enhanced patient convenience over native L-asparaginase (nonpegylated form). Through the process of pegylation, the half-life of L-asparaginase is significantly increased 1,2,4 and the L-asparaginase activity is sustained. 4-7

ONCASPAR can be administered through intramuscular (IM) injection or intravenous (IV) infusion. When utilized as a component of induction therapy for ALL, 1 dose of Oncaspar achieved similar levels of asparagine depletion as 9 doses of native L-asparaginase.3,5,*

The use of ONCASPAR for the treatment of ALL continues to be explored to evaluate the optimal duration of use.

ONCASPAR is indicated as a component of a multiagent chemotherapeutic regimen for the first –line treatment of patients with acute lymphoblastic leukemia (ALL) and for the treatment of patients with acute lymphoblastic leukemia and hypersensitivity to native forms of L-asparaginase. 3

ONCASPAR is contraindicated in patients with a history of serious allergic reactions to ONCASPAR, and in patients with a history of serious thrombosis, pancreatitis, or serious hemorrhagic events with prior L-asparaginase therapy.

ONCASPAR should be discontinued in the case of anaphylaxis or serious allergic reactions, thrombosis, or pancreatitis. Glucose intolerance, in some cases irreversible, can occur. Coagulopathy can occur. Perform appropriate monitoring.

The most common adverse reactions with ONCASPAR (>2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases.

In study 2 (n= 2770), the per-patient incidence for Grades 3 and 4 nonhematologic toxicities were: elevated transaminases (11%), coagulopathy (7%), hyperglycemia (5%), CNS thrombosis/hemorrhage (2%), pancreatitis (2%), clinical allergic reaction (1%), and hyperbilirubinemia (1%). There were 3 deaths due to pancreatitis.

*1 to 6 conversion of ONCASPAR to native L-asparaginase in other phases of treatment.

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