Gespar 3750IU Injection

Pegaspargase 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) Pegaspargase ® 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 Pegaspargase 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.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Anaphylaxis or serious hypersensitivity reactions: Observe patients for 1 hour after administration. Discontinue Pegaspargase in patients with serious hypersensitivity reactions. Thrombosis: Discontinue Pegaspargase in patients with serious thrombotic events. Pancreatitis: Evaluate patients with abdominal pain for pancreatitis. Discontinue Pegaspargase in patients with pancreatitis. Glucose intolerance: Monitor serum glucose. Hemorrhage: Discontinue Pegaspargase for severe or life-threatening hemorrhage. Evaluate for etiology and treat. Hepatotoxicity, including hepatic veno-occlusive disease (VOD): Monitor for toxicity through recovery from cycle. Discontinue Pegaspargase for severe liver toxicity. Anaphylaxis and Serious Hypersensitivity Reactions Anaphylaxis and serious hypersensitivity reactions can occur in patients receiving Pegaspargase. The risk of serious hypersensitivity reactions is higher in patients with known hypersensitivity to ( E.) coli derived L-asparaginase formulations. Other hypersensitivity reactions can include angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnea, pruritus, and rash. Premedicate patients 30-60 minutes prior to administration of Pegaspargase.. Observe patients for 1 hour after administration of Pegaspargase in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines). Thrombosis Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving Pegaspargase. Discontinue Pegaspargase in patients with serious thrombotic events. Pancreatitis can occur in patients receiving Pegaspargase. Hemorrhagic or necrotizing pancreatitis with fatal outcomes have been reported. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to confirm early signs of pancreatic inflammation. Discontinue Pegaspargase in patients where pancreatitis is suspected. If pancreatitis is confirmed, do not resume Pegaspargase. Glucose Intolerance Glucose intolerance can occur in patients receiving Pegaspargase. In some cases, glucose intolerance is irreversible. Monitor serum glucose. Hemorrhage Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur in patients receiving Pegaspargase. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy. Discontinue Pegaspargase for severe or life-threatening hemorrhage. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and serious hypersensitivity reactions Thrombosis Pancreatitis Glucose intolerance Hemorrhage Hepatotoxicity, including VOD The most common (>5%) grade > 3 adverse reactions with Pegaspargase are hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The most common grade 3 and 4 adverse reactions (>5%) included: hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections. First-Line Treatment of Acute Lymphoblastic Leukemia (ALL) Study CCG-1962 was a randomized (1:1), active controlled study that enrolled 118 patients, with a median age of 4.7 years (1.1-9.9 years), of whom 54% were males and 65% White, 14% Hispanic, 8% Black, 8% Asian, and 6% other race. Of the 59 patients in Study 1 who were randomized to Pegaspargase, 48 patients (81%) received all 3 planned doses of Pegaspargase, 6 (10%) received 2 doses, 4 (7%) received 1 dose, and 1 patient (2%) did not receive the assigned treatment. In Study CCG-1962, detailed safety information was collected for pre-specified adverse reactions identified as asparaginase induced adverse reactions and for grade 3 and 4 nonhematologic adverse reactions according to the Children's Cancer Group (CCG) Toxicity and Complication Criteria. The per-patient incidence, by treatment arm, for these selected adverse reactions occurring at a severity of grade 3 or 4 are presented in Table 2: Table 2. Incidence of Selected Grades 3 and 4 Adverse Reactions in Study CCG-1962 Pegaspargase (n=58) Native E. coli L-Asparaginase (n=59) Infection 3 (5%) 3 (5%) Abnormal Liver Tests 3 (5%) 5 (8%) Elevated Transaminases Aspartate aminotransferase, alanine aminotransferase. 2 (3%) 4 (7%) Hyperbilirubinemia 1 (2%) 1 (2%) Hyperglycemia 3 (5%) 2 (3%) Central Nervous System Thrombosis 2 (3%) 2 (3%) Coagulopathy Prolonged prothrombin time or partial thromboplastin time; or hypofibrinogenemia. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.