| Systematic (IUPAC) name | |
|---|---|
| Human granulocyte macrophage colony stimulating factor | |
| Clinical data | |
| AHFS/Drugs.com | monograph |
| MedlinePlus | a693005 |
| Pregnancy cat. | ? |
| Legal status | Rx only |
| Identifiers | |
| CAS number | 83869-56-1 |
| ATC code | L03AA09 |
| DrugBank | BTD00035 |
| UNII | 5TAA004E22 |
| ChEMBL | CHEMBL1201670 |
| Chemical data | |
| Formula | C639H1006N168O196S8 |
| Mol. mass | 14434.5 g/mol |
| (what is this?) (verify) |
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Sargramostim (marketed by Genzyme under the tradename Leukine) is a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) that functions as an immunostimulator.[1]
Contents |
Sargramostim is primarily used for myeloid reconstitution after autologous or allogeneic bone marrow transplantation. It is also used to treat neutropenia 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).[3]
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.
Sargramostim was approved by the US 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.[4][5][6]
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 The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the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.[1]
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