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Berlex Oncology Introduces New Formulation of Leukine with Extended Shelf Life
New Formulation of 500-mcg/mL Vial Will Provide Added Convenience for Customers
SEATTLE, WA -- January 10, 2006 -- Berlex Oncology, a unit of Berlex Laboratories, a U.S. affiliate of Schering AG, Germany, today announced its granulocyte macrophage colony stimulating factor (GM-CSF) Leukine(R) (sargramostim) 500-mcg/mL vial has been reformulated to deliver extended shelf life and thereby, added convenience for customers.
The new formulation of Leukine, a growth factor that helps fight infection in appropriate patients by enhancing cells of the immune system, now includes the preservative EDTA (edetate disodium). Launch of the new formulation is anticipated in late January, 2006.
As part of the formulation change, the Leukine 500-mcg/mL vial also will have new packaging, as well as a new NDC number: 50419-595-05. The current NDC number (50419-050-30) will remain on the market for a limited time period; therefore, customers should not delete or inactivate it in their systems.
The 250 mcg vial (NDC number 50419-002-33) of Leukine will continue to be marketed in its current formulation of lyophilized powder.
The reformulation will not affect reimbursement or claims submissions, as the HCPCS code (J2820 - sargramostim 50 mcg) remains the same for both formulations, and claims can be filed in the usual manner. Additionally, the indications and usage, as well as the dosage and administration, of this reformulated version of Leukine remain the same.
Healthcare professionals should direct any questions regarding the new Leukine formulation to their Berlex sales consultant, or call Berlex Oncology Medical Information Services at 1-888-BERLEX4 (1-888-237-5394).
About Leukine
Leukine, a growth factor involved in fighting infection by enhancing immune cell function, was approved in the U.S. in 1991, and is marketed by Berlex Oncology. Leukine is the only growth factor approved in the U.S. for use following induction chemotherapy in older adults with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections.
Leukine has also been approved in the U.S. for use in four additional indications: myeloid reconstitution following allogeneic and autologous bone marrow transplantation (BMT), peripheral blood stem cell (PBSC) mobilization and subsequent myeloid reconstitution in patients undergoing PBSC transplantation, and bone marrow transplantation failure or engraftment delay. Leukine has been administered to more than 300,000 patients worldwide.
Patients taking Leukine may experience some side effects, most of which are mild to moderate. Some common side effects may include bone pain, a slight temperature elevation (usually less than 100.5 degrees F or 38 degrees C) for a short period of time after the injection, and swelling, redness, and/or discomfort around the injection site.
SOURCE: Berlex Oncology
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