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Sigma-Tau Pharmaceuticals Announces Approval for New Manufacturing Process for ONCASPAR® (Pegaspargase) Primary Ingredient
Date:4/18/2011

as 9 doses of native L-asparaginase.

The use of ONCASPAR for the treatment of ALL continues to be explored to evaluate the optimal duration of use.

ONCASPAR is indicated as a component of a multiagent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL) and for the treatment of patients with acute lymphoblastic leukemia and hypersensitivity to native forms of L-asparaginase.

ONCASPAR is contraindicated in patients with a history of serious allergic reactions to ONCASPAR, and in patients with a history of serious thrombosis, pancreatitis, or serious hemorrhagic events with prior L-asparaginase therapy.

ONCASPAR should be discontinued in the case of anaphylaxis or serious allergic reactions, thrombosis, or pancreatitis. Glucose intolerance, in some cases irreversible, can occur. Coagulopathy can occur. Perform appropriate monitoring.

The most common adverse reactions with ONCASPAR (>2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases.

In study 2 (n= 2770), the per-patient incidence for Grades 3 and 4 nonhematologic toxicities were: elevated transaminases (11%), coagulopathy (7%), hyperglycemia (5%), CNS thrombosis/hemorrhage (2%), pancreatitis (2%), clinical allergic reaction (1%), and hyperbilirubinemia (1%). There were 3 deaths due to pancreatitis.

*1 to 6 conversion of ONCASPAR to native L-asparaginase in other phases of treatment.

About Sigma-Tau Pharmaceuticals, Inc.:

Sigma-Tau Pharmaceuticals, Inc. is a U.S. based, wholly owned subsidiary of the sigma-tau Group, and is dedicated solely to the global development and commercialization of medicines for patients with rare diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland.  Since 1989, the company's products have been focused on
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