ts with prior L-asparaginase therapy
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylaxis and Serious Allergic Reactions
Serious allergic reactions can occur in patients receiving Elspar. The risk of serious allergic reactions is higher in patients with prior exposure to Elspar or other Escherichia coli-derived L-asparaginases. Observe patients for one hour after administration of Elspar in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines). Discontinue Elspar in patients with serious allergic reactions.
5.2 Thrombosis
Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving Elspar. Discontinue Elspar in patients with serious thrombotic events.
5.3 Pancreatitis
Pancreatitis, in some cases fulminant or fatal, can occur in patients receiving Elspar. eva luate patients with abdominal pain for evidence of pancreatitis. Discontinue Elspar in patients with pancreatitis.
5.4 Glucose Intolerence
Glucose intolerance can occur in patients receiving Elspar. In some cases, glucose intolerance is irreversible. Monitor serum glucose.
5.5 Coagulopathy
Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur in patients receiving Elspar. CNS hemorrhages have been observed. Monitor coagulation parameters at baseline and periodically during and after treatment. Initiate treatment with fresh-frozen plasma to replace coagulation factors in patients with severe or symptomatic coagulopathy.
5.6 Hepatotoxicity and Abnormal Liver Function
Hepatotoxicity, liver disorder and a variety of liver function abnormalities have been reported including elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin (direct and indirect), and depression of serum albumin, and plasma fibrinogen. Marked hypoalbuminemia associated with peripheral edema has been reported. However, these abnormalities usually are reversible on discontinuance of therapy and some reversal may occur during the course of therapy, Fatty changes in the liver have been documented on biopsy. Hepatic failure has been reported.
6 ADVERSE REACTIONS
The following serious adverse reactions occur with Elspar treatment [see Warnings and Precautions (5)]:
Anaphylaxis and serious allergic reactions
Serious thrombosis
Pancreatitis
Glucose intolerance
Coagulopathy
Hepatotoxicity and abnormal liver function
The most common adverse reactions with Elspar are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases.
6.1 Clinical Trials and Post-Marketing Experience
The adverse reactions included in this section were identified in single-arm clinical trials in which Elspar was administered as part of a multi-agent regimen or from spontaneous post-marketing reports or published literature.
Because these adverse events were identified in clinical trials that were not designed to isolate the adverse effects of Elspar or were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serious Adverse Reactions
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