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Erwinaze® (asparaginase Erwinia chrysanthemi) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

Contraindications:

Erwinaze is contraindicated in patients with a history of:

 

Warnings and Precautions

Serious Hypersensitivity Reactions, Including Anaphylaxis
In clinical trials, 5% of patients had serious hypersensitivity reactions including anaphylaxis after Erwinaze use. Discontinue Erwinaze if a serious hypersensitivity reaction occurs and initiate appropriate therapy. Administer in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis.

Pancreatitis
In clinical trials, 4% of patients reported pancreatitis with Erwinaze therapy. Discontinue Erwinaze for severe or hemorrhagic pancreatitis manifested by abdominal pain >72 hours and amylase elevation ≥2.0 x ULN. In case of mild pancreatitis, hold Erwinaze until the signs and symptoms subside and amylase levels return to normal. After resolution, Erwinaze therapy may be resumed.

Glucose Intolerance
In clinical trials, 2% of patients reported glucose intolerance, which may be irreversible in some cases. Monitor glucose levels 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 in both E. coli and Erwinia-derived L-asparaginase therapy. Discontinue Erwinaze for a thrombotic or hemorrhagic event until symptoms resolve; after resolution, Erwinaze therapy may be resumed.

Most Common Adverse Reactions
The most common adverse reactions (incidence >1%) with Erwinaze treatment were serious hypersensitivity reactions, including anaphylaxis, pancreatitis, abnormal transaminases, coagulation abnormalities including thrombosis and hemorrhage, nausea and vomiting, and hyperglycemia.

Pregnancy
Pregnancy category C. 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. 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.

Geriatric Use
The safety and efficacy of Erwinaze has not been studied in geriatric patients.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.