Intended for US Audience Only

ONCASPAR (pegaspargase)

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ONCASPAR (pegaspargase) is given to patients with acute lymphoblastic leukemia (ALL) as part of a group of chemotherapy medications. ONCASPAR is administered IM/IV* and should not be given more frequently than every 14 days.

For more information, see the Indication and Important Safety Information below, and download the Full Prescribing Information here.

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*IM=Intramuscular; IV=Intravenous.

Indication and Usage

ONCASPAR (pegasapragase) is indicated as a component of multi-agent chemotherapeutic regimen for treatment of patients with:

Detailed Important Safety Information

CONTRAINDICATIONS
WARNINGS and PRECAUTIONS

Anaphylaxis and Hypersensitivity: Anaphylaxis or serious allergic reactions can occur; therefore, patients should be observed for one hour after administration. Discontinue ONCASPAR in patients with serious allergic reactions.

Thrombotic Events: Serious thrombotic events, including sagittal sinus thrombosis can occur. Discontinue Oncaspar in patients with serious thrombotic events

Pancreatitis: Pancreatitis can occur. Evaluate patients with abdominal pain for evidence of pancreatitis. Discontinue Oncaspar in patients with pancreatitis

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

Coagulopathy: Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur. Monitor coagulation parameters at baseline and periodically during and after treatment.

Hepatotoxicity: Hepatotoxicity and abnormal liver function, can occur. Perform appropriate monitoring.

ADVERSE REACTIONS

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.

Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

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SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
ONCASPAR is a registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.
All other product brands or trademarks appearing herein are the property of their respective owners.

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