Included as part of the PRECAUTIONS section.

Serious hypersensitivity reactions, including anaphylaxis

Serious hypersensitivity reactions, including anaphylaxis have occurred after the use of ERWINAZE in 5% of patients in clinical trials [see ADVERSE REACTIONS].

Administer this product in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. If a serious hypersensitivity reaction occurs, discontinue ERWINAZE and initiate appropriate therapy.

Pancreatitis

Pancreatitis has been reported with ERWINAZE therapy in 4% of patients in clinical trials [see ADVERSE REACTIONS].

Evaluate patients with symptoms compatible with pancreatitis to establish a diagnosis. Discontinue ERWINAZE for severe or hemorrhagic pancreatitis manifested by abdominal pain > 72 hours and amylase elevation ≥ 2.0 x ULN. Severe pancreatitis is a contraindication to additional asparaginase administration. In the case of mild pancreatitis, hold ERWINAZE until the signs and symptoms subside and amylase levels return to normal. After resolution, treatment with ERWINAZE may be resumed.

Glucose Intolerance

Glucose intolerance has been reported with ERWINAZE therapy in 2% of patients in clinical trials and in some cases, may be irreversible [see ADVERSE REACTIONS]. Monitor glucose levels in patients at baseline and periodically during treatment. Administer insulin therapy as necessary in patients with hyperglycemia.

Thrombosis and Hemorrhage

Serious thrombotic events, including sagittal sinus thrombosis have been reported with both E. coli and Erwinia-derived L-asparaginase therapy. The following coagulation proteins were decreased in the majority of patients after a 2-week course of ERWINAZE: fibrinogen, protein C activity, protein S activity, and anti-thrombin III. Discontinue ERWINAZE for a thrombotic or hemorrhagic event until symptoms resolve; after resolution, treatment with ERWINAZE may be resumed.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term carcinogenicity studies in animals have been performed with asparaginase Erwinia chrysanthemi. No studies that assess the mutagenic potential of asparaginase Erwinia chrysanthemi have been conducted. No studies that assess the effects of asparaginase Erwinia chrysanthemi on fertility have been performed.

Use In Specific Populations

Pregnancy

Pregnancy category C. There are no adequate and well-controlled studies of ERWINAZE in pregnant women. Animal reproduction studies have not been conducted with ERWINAZE. It is not known whether ERWINAZE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ERWINAZE should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether ERWINAZE is secreted in human milk. Because many drugs are secreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ERWINAZE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

[see Clinical Studies]

Geriatric Use

The safety and efficacy of ERWINAZE has not been studied in geriatric patients.

Last reviewed on RxList: 12/5/2011
This monograph has been modified to include the generic and brand name in many instances.