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Oncaspar

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Oncaspar

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis And Serious Allergic Reactions

Anaphylaxis and serious allergic reactions can occur in patients receiving Oncaspar® . The risk of serious allergic reactions is higher in patients with known hypersensitivity to other forms of L-asparaginase. Observe patients for 1 hour after administration of Oncaspar® in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines). Discontinue Oncaspar® in patients with serious allergic reactions.

Thrombosis

Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving Oncaspar® . Discontinue Oncaspar® in patients with serious thrombotic events.

Pancreatitis

Pancreatitis can occur in patients receiving Oncaspar® . Evaluate patients with abdominal pain for evidence of pancreatitis. Discontinue Oncaspar® in patients with pancreatitis.

Glucose Intolerance

Glucose intolerance can occur in patients receiving Oncaspar® . In some cases, glucose intolerance is irreversible.

Coagulopathy

Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur in patients receiving Oncaspar® . 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.

Hepatotoxicity And Abnormal Liver Function

Hepatotoxicity and abnormal liver function, including elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin (direct and indirect), and depression of serum albumin, and plasma fibrinogen can occur. Perform appropriate monitoring.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

  • No long-term carcinogenicity studies in animals have been performed with Oncaspar® .
  • No relevant studies addressing mutagenic potential have been conducted. Oncaspar® did not exhibit a mutagenic effect when tested against Salmonella typhimurium strains in the Ames assay.
  • No studies have been performed on impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Oncaspar® . It is also not known whether Oncaspar® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Oncaspar® should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Oncaspar® 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 Oncaspar®, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

[see Clinical Studies]

Geriatric Use

Clinical studies of Oncaspar® did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.

Last reviewed on RxList: 5/2/2014
This monograph has been modified to include the generic and brand name in many instances.

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