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Included as part of the PRECAUTIONS section.

Anaphylaxis and Serious Allergic Reactions

Serious allergic reactions can occur in patients receiving Oncaspar® (pegaspargase) . 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® (pegaspargase) in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines). Discontinue Oncaspar® (pegaspargase) in patients with serious allergic reactions.

Thrombosis

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

Pancreatitis

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

Glucose Intolerance

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

Coagulopathy

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

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

• No long-term carcinogenicity studies in animals have been performed with Oncaspar® (pegaspargase) .
• No relevant studies addressing mutagenic potential have been conducted. Oncaspar® (pegaspargase) 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® (pegaspargase) . It is also not known whether Oncaspar® (pegaspargase) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Oncaspar® (pegaspargase) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Oncaspar® (pegaspargase) 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® (pegaspargase) , 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® (pegaspargase) 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: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.