Bionase 5K Injection

Asparaginase is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. Asparaginase is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived 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.

• Hypersensitivity: Monitor for signs or symptoms. Discontinue Asparaginase for serious reaction. - Pancreatitis: Monitor for symptoms. Discontinue if pancreatitis occurs. - Thrombosis: Discontinue Asparaginase for severe or life-threatening thrombosis. Provide anticoagulation therapy as indicated. - Hemorrhage: Discontinue Asparaginase for severe or life-threatening hemorrhage. - Hepatotoxicity, including hepatic veno-occlusive disease: Discontinue Asparaginase for grade 4 increases of bilirubin. Hypersensitivity Reactions Hypersensitivity reactions after the use of Asparaginase occurred in 29% of patients in clinical trials, and it was severe in 6% of patients. Anaphylaxis was observed in 2% of patients after intramuscular administration. Discontinuation of Asparaginase due to hypersensitivity reactions occurred in 5% of patients. Hypersensitivity reactions were higher in patients who received intravenous asparaginase erwinia chrysanthemi (recombinant)-rywn. The intravenous route of administration is not approved. In patients administered Asparaginase intramuscularly in clinical trials, the median number of doses of Asparaginase that patients received prior to the onset of the first hypersensitivity reaction was 12 doses (range: 1-64 doses). The most commonly observed reaction was rash (19%), and 1 patient (1%) experienced a severe rash. Hypersensitivity reactions observed with L-asparaginase class products include angioedema, urticaria, lip swelling, eye swelling, rash or erythema, blood pressure decreased, bronchospasm, dyspnea, and pruritus. Premedicate patients prior to administration of Asparaginase as recommended. Because of the risk of serious allergic reactions (e.g., life-threatening anaphylaxis), administer Asparaginase in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines). Discontinue Asparaginase in patients with serious hypersensitivity reactions. Pancreatitis, including elevated amylase or lipase, was reported in 20% of patients in clinical trials of Asparaginase and was severe in 8%. Symptomatic pancreatitis occurred in 7% of patients, and it was severe in 6% of patients. Elevated amylase or lipase without symptomatic pancreatitis was observed in 13% of patients treated with Asparaginase. Hemorrhagic or necrotizing pancreatitis have been reported with L-asparaginase class products. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Evaluate patients with symptoms compatible with pancreatitis to establish a diagnosis. Assess serum amylase and lipase levels in patients with any signs or symptoms of pancreatitis. Discontinue Asparaginase in patients with severe or hemorrhagic pancreatitis. 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 in greater detail in other sections of the labeling: - Hypersensitivity Reactions - Pancreatic Toxicity - Thrombosis - Hemorrhage - Hepatotoxicity, including VOD Most common adverse reactions (incidence > 20%) are abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Asparaginase described in the WARNINGS AND PRECAUTIONS reflect exposure in 167 patients administered Asparaginase intramuscularly at various dosages when used in combination with chemotherapy in study JZP458-201. These patients received a median of 4 courses of Asparaginase (range: 1-15 courses); 65% of patients received at least four courses. The safety of Asparaginase described below and in Table 3 was evaluated in study JZP458-201, a multi-cohort study. Patients received Asparaginase administered intramuscularly at dosages of 25 mg/m 2 on Monday, Wednesday, and Friday or 25 mg/m 2 on Monday and Wednesday, and 50 mg/m 2 on Friday, for 6 doses as a replacement for a single dose of pegaspargase as a component of multi-agent chemotherapy. The patients had a median age of 11 years (range: 1‑25 years); the majority of patients were male (57%) and White (68%). The patients received a median of 4 courses of Asparaginase (range: 1-14 courses); A fatal adverse reaction (infection) occurred in 1 patient treated with the Asparaginase 25/25/25 mg/m 2 dosage. Serious adverse reactions occurred in 60% of patients who received the recommended dosages of Asparaginase. The most frequent nonhematological serious adverse reactions (in ≥ 5% of patients) were febrile neutropenia, infection, drug hypersensitivity, pyrexia, nausea, dehydration, stomatitis, acute kidney injury, pancreatitis, diarrhea, and viral infection. Permanent discontinuation due to an adverse reaction occurred in 10% of patients who received Asparaginase intramuscularly at the recommended dosages. Adverse reactions resulting in permanent discontinuation included pancreatitis (5%), drug hypersensitivity (4%), and infection (1%). 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.