Sargramostim: Difference between revisions
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==History== |
==History== |
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Sargramostim was approved by the [[United States|US]] [[Food and Drug Administration|FDA]] on |
Sargramostim was approved by the [[United States|US]] [[Food and Drug Administration|FDA]] on March 5, 1991 under the trade name Leukine. |
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On |
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 The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the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] |
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==References== |
==References== |
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Revision as of 22:16, 29 November 2009
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| Formula | C639H1006N168O196S8 |
| Molar mass | 14434.5 g/mol g·mol−1 |
Sargramostim (marketed by Bayer under the tradename Leukine) is a recombinant granulocyte macrophage colony-stimulating factor that functions as an immunostimulator.[1]
Therapeutic uses
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 dis-orders.
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 US FDA on March 5, 1991 under the trade name Leukine.
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 The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the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]
References
- ^ Kirman I, Belizon A, Balik E; et al. (2007). "Perioperative sargramostim (recombinant human GM-CSF) induces an increase in the level of soluble VEGFR1 in colon cancer patients undergoing minimally invasive surgery". European Journal of Surgical Oncology (EJSO). 33: 1169. doi:10.1016/j.ejso.2007.03.014. PMID 17512160.
{{cite journal}}: Explicit use of et al. in:|author=(help)CS1 maint: multiple names: authors list (link) - ^ Beveridge RA, Miller JA, Kales AN; et al. (1998). "A comparison of efficacy of sargramostim (yeast-derived RhuGM-CSF) and filgrastim (bacteria-derived RhuG-CSF) in the therapeutic setting of chemotherapy-induced myelosuppression". Cancer Invest. 16 (6): 366–73. doi:10.3109/07357909809115775. PMID 9679526.
{{cite journal}}: Explicit use of et al. in:|author=(help)CS1 maint: multiple names: authors list (link)