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ONCASPAR® INDICATIONS AND IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
WARNINGS and PRECAUTIONS
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. Premedicate patients 30-60 minutes prior to administration of ONCASPAR. 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, which, if left untreated, could be fatal. Discontinue ONCASPAR in patients where pancreatitis is suspected. If pancreatitis is confirmed, do not resume ONCASPAR.
Glucose Intolerance: Glucose intolerance can occur and, in some cases, be irreversible. Monitor serum glucose.
Hemorrhage: Increased prothrombin time (PT), increased partial thromboplastin time (PTT), 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. Discontinue ONCASPAR for severe or life-threatening hemorrhage.
Hepatotoxicity: Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ONCASPAR in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy. Do not administer ONCASPAR to patients with severe hepatic impairment. Evaluate bilirubin and transaminases prior to each dose of ONCASPAR and at least weekly, during cycles of treatment that include ONCASPAR, through 6 weeks after the last dose of ONCASPAR. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ONCASPAR, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ONCASPAR and provide supportive care.
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,
hypersensitivity, sepsis, and infections.
Please see the accompanying ONCASPAR Full Prescribing Information.
ONCASPAR is a registered trademark of Servier IP UK Ltd., a wholly-owned, indirect subsidiary of Les Laboratoires Servier. Servier and the Servier logo are trademarks of Les Laboratoires Servier.
INDICATIONS AND USAGE
ONCASPAR® (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with:
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
WARNINGS and PRECAUTIONS
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. Premedicate patients 30-60 minutes prior to administration of ONCASPAR. 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, which, if left untreated, could be fatal. Discontinue ONCASPAR in patients where pancreatitis is suspected. If pancreatitis is confirmed, do not resume ONCASPAR.
Glucose Intolerance: Glucose intolerance can occur and, in some cases, be irreversible. Monitor serum glucose.
Hemorrhage: Increased prothrombin time (PT), increased partial thromboplastin time (PTT), 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. Discontinue ONCASPAR for severe or life-threatening hemorrhage.
Hepatotoxicity: Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ONCASPAR in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy. Do not administer ONCASPAR to patients with severe hepatic impairment. Evaluate bilirubin and transaminases prior to each dose of ONCASPAR and at least weekly, during cycles of treatment that include ONCASPAR, through 6 weeks after the last dose of ONCASPAR. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ONCASPAR, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ONCASPAR and provide supportive care.
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, hypersensitivity,
sepsis, and infections.
Please see the accompanying ONCASPAR Full Prescribing Information.
ONCASPAR is a registered trademark of Servier IP UK Ltd., a wholly-owned, indirect subsidiary of Les Laboratoires Servier. Servier and the Servier logo are trademarks of Les Laboratoires Servier.
INDICATIONS AND USAGE
ONCASPAR® (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with:
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