Sargramostim
Encyclopedia
Sargramostim is a recombinant
granulocyte macrophage colony-stimulating factor (GM-CSF) that functions as an immunostimulator
.
It is produced in yeast
.
induced by chemotherapy during the treatment of acute myeloid leukemia
. Sargramostim has recently shown promise in treating Crohn's disease and other GI inflammatory disorders. This medication is being investigated in trials to treat Autoimmune Pulmonary Alveolar Protienosis (PAP).
FDA
on March 5, 1991 under the trade name Leukine. Leukine was first marketed by Immunex, which was acquired by Amgen
in 2002. As part of the acquisition, the production of Leukine was spun off to Berlex, which later became Bayer HealthCare. In 2009, Genzyme
acquired the rights to Leukine from Bayer, including the manufacturing facility in the Seattle area.
On January 23, 2008, Bayer informed healthcare professionals of the market withdrawal of the current liquid formulation of sargramostim. The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized sargramostim.http://www.fda.gov/medwatch/safety/2008/Leukine_DHCP_01-23-2008.pdf
Recombinant DNA
Recombinant DNA molecules are DNA sequences that result from the use of laboratory methods to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms...
granulocyte macrophage colony-stimulating factor (GM-CSF) that functions as an immunostimulator
Immunostimulator
Immunostimulants, also known as immunostimulators, are substances that stimulate the immune system by inducing activation or increasing activity of any of its components...
.
It is produced in yeast
Yeast
Yeasts are eukaryotic micro-organisms classified in the kingdom Fungi, with 1,500 species currently described estimated to be only 1% of all fungal species. Most reproduce asexually by mitosis, and many do so by an asymmetric division process called budding...
.
Therapeutic uses
Sargramostim is primarily used for myeloid reconstitution after autologous or allogeneic bone marrow transplantation. It is also used to treat neutropeniaNeutropenia
Neutropenia, from Latin prefix neutro- and Greek suffix -πενία , is a granulocyte disorder characterized by an abnormally low number of neutrophils, the most important type of white blood cell...
induced by chemotherapy during the treatment of acute myeloid leukemia
Acute myeloid leukemia
Acute myeloid leukemia , also known as acute myelogenous leukemia, is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. AML is the most common acute...
. Sargramostim has recently shown promise in treating Crohn's disease and other GI inflammatory disorders. This medication is being investigated in trials to treat Autoimmune Pulmonary Alveolar Protienosis (PAP).
Contraindications
Sargramostim should not be used in patients with excessive leukemic myeloid blasts in the bone marrow or peripheral blood (≥ 10%), in patients with known hypersensitivity to GM-CSF, yeast-derived products or any component of the product and for concomitant use with chemotherapy and radiotherapy.History
Sargramostim was approved by the USUnited States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
on March 5, 1991 under the trade name Leukine. Leukine was first marketed by Immunex, which was acquired by Amgen
Amgen
Amgen Inc. is an international biotechnology company headquartered in Thousand Oaks, California. Located in the Conejo Valley, Amgen is the world's largest independent biotech firm. The company employs approximately 17,000 staff members. Its products include Epogen, Aranesp, Enbrel, Kineret,...
in 2002. As part of the acquisition, the production of Leukine was spun off to Berlex, which later became Bayer HealthCare. In 2009, Genzyme
Genzyme
Genzyme Corporation is a fully owned subsidiary of Sanofi-Aventis. Before its acquisition, Genzyme was an American biotechnology company based in Cambridge, Massachusetts. In 2010, Genzyme was the world’s third-largest biotechnology company, employing more than 11,000 people around the world...
acquired the rights to Leukine from Bayer, including the manufacturing facility in the Seattle area.
On January 23, 2008, Bayer informed healthcare professionals of the market withdrawal of the current liquid formulation of sargramostim. The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized sargramostim.http://www.fda.gov/medwatch/safety/2008/Leukine_DHCP_01-23-2008.pdf
External links
- Leukine product website from Genzyme
- Leukine prescribing information