Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze® (asparaginase Erwinia chrysanthemi) - Seite 2

Erwinaze is contraindicated in patients with a history of serious hypersensitivity reactions to Erwinaze, including anaphylaxis; or where serious pancreatitis, serious thrombosis or serious hemorrhagic events occurred with prior L-asparaginase therapy. Discontinue Erwinaze if serious hypersensitivity, including anaphylaxis, or severe or hemorrhagic pancreatitis occurs and initiate appropriate therapy. Administer in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Glucose intolerance has been reported which, in some cases may be irreversible. Discontinue Erwinaze if a serious thrombotic or hemorrhagic event occurs until symptoms resolve.

The most common adverse reactions (incidence 1% or greater) with Erwinaze treatment are systemic hypersensitivity, hyperglycemia, abnormal transaminases, fever, pancreatitis, local reactions, vomiting, nausea, thrombosis, hyperbilirubinemia, abdominal pain/discomfort and diarrhea. To see full prescribing information, visit www.erwinaze.com

About ALL
Acute lymphoblastic leukemia (ALL) is a cancer that affects the white blood cells. Approximately 5,000-6,000 new patients are diagnosed in the U.S. per year⁴. ALL is the most common cancer in children⁵. While treatment outcomes in adult ALL have remained largely unchanged, treatment outcomes have significantly improved in children, with 5-year survival rates over 80%⁴. Asparaginase treatment is recommended as an important component of a multi-agent chemotherapy regimen in ALL⁶.

About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing differentiated products that address unmet medical needs. The company has a diverse portfolio of products and/or product candidates in the areas of sleep, hematology/oncology, pain and psychiatry. The company's U.S. marketed products in these areas include: Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Prialt® (ziconotide) intrathecal infusion, Versacloz® (clozapine) oral suspension, FazaClo® (clozapine, USP) HD and FazaClo LD. Jazz Pharmaceuticals also has a number of products marketed outside the U.S., including Erwinase® and Defitelio® (defibrotide). For more information, please visit www.jazzpharmaceuticals.com