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Anaphylaxis and Serious Allergic Reactions
Serious allergic reactions can occur in patients receiving Elspar (asparaginase) . 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 (asparaginase) in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines).Discontinue Elspar (asparaginase) in patients with serious allergic reactions.
Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving Elspar (asparaginase) . Discontinue Elspar (asparaginase) in patients with serious thrombotic events.
Pancreatitis, in some cases fulminant or fatal, can occur in patients receiving Elspar (asparaginase) . Evaluate patients with abdominal pain for evidence of pancreatitis. Discontinue Elspar (asparaginase) in patients with pancreatitis.
Glucose intolerance can occur in patients receiving Elspar (asparaginase) . In some cases, glucose intolerance is irreversible. Monitor serum glucose.
Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur in patients receiving Elspar (asparaginase) . 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.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No long-term carcinogenicity studies in animals have been performed with Elspar (asparaginase) .
No studies have been performed on impairment of fertility.
Use In Specific Populations
Pregnancy Category C. In mice and rats Elspar (asparaginase) has been shown to retard the weight gain of mothers and fetuses when given in doses of more than 1000 International Units/kg (approximately equivalent to the recommended human dose, when adjusted for total body surface area). Resorptions, gross abnormalities and skeletal abnormalities were observed. The intravenous administration of 50 or 100 International Units/kg (approximately equivalent to 10 to 20% of the recommended human dose, when adjusted for total body surface area) to pregnant rabbits on Day 8 and 9 of gestation resulted in dose dependent embryotoxicity and gross abnormalities. There are no adequate and well-controlled studies in pregnant women. Elspar (asparaginase) should be given to a pregnant woman only if clearly needed.
It is not known whether Elspar (asparaginase) is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ELSPAR (asparaginase) , a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
[See Clinical Studies]
Clinical studies of Elspar (asparaginase) did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.
Last reviewed on RxList: 10/10/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Elspar Information
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