ONCASPAR® (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with:

  • First-line acute lymphoblastic leukemia (ALL)
  • ALL and hypersensitivity to native forms of L-asparaginase

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • 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.

WARNINGS and PRECAUTIONS

Anaphylaxis Anaphylaxis and Serious Hypersensitivity Reactions: Anaphylaxis and serious hypersensitivity reactions can occur. The risk of serious hypersensitivity reactions is higher in patients with known hypersensitivity to E. coli derived L-asparaginase formulations. Observe patients for 1 hour after administration in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Discontinue ONCASPAR in patients with serious hypersensitivity reactions.

Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, can occur. Discontinue ONCASPAR in patients with serious thrombotic events.

Pancreatitis: Pancreatitis can occur. Fatal outcomes have been reported. Inform patients of the signs and symptoms of pancreatitis. Discontinue ONCASPAR in patients where pancreatitis is suspected. If pancreatitis is confirmed, do not resume ONCASPAR.

Glucose Intolerance: Glucose intolerance can occur. In some cases, glucose intolerance is irreversible. Monitor serum glucose.

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Hemorrhage: Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.

Hepatotoxicity: Hepatotoxicity and abnormal liver function can occur. Evaluate bilirubin and transaminases at least weekly during cycles of treatment through at least 6 weeks after the last dose. In the event of serious liver toxicity, discontinue ONCASPAR.

ADVERSE REACTIONS

The most common grade 3 and 4 adverse reactions with ONCASPAR (>5%) included hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, and hypersensitivity.