|Systematic (IUPAC) name|
|Human granulocyte macrophage colony stimulating factor|
|(what is this?)|
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 Proteinosis (PAP).
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.
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 The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the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. The original liquid formulation (without EDTA) was returned to the market in the US shortly after the EDTA-containing liquid formulation was withdrawn.
- 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 33 (10): 1169–1176. doi:10.1016/j.ejso.2007.03.014. PMID 17512160.
- 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): 366–373. doi:10.3109/07357909809115775. PMID 9679526.
- "Whole Lung Lavage (WLL)/Inhaled Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis (PAP). Phase II/III trial 2009-2013". Clinicaltrials.gov. Retrieved 2012-06-20.
- "Immunex Corporation". Company Histories & Profiles. FundingUniverse.com. Retrieved 12 November 2011.
- "Bayer Healthcare Pharmaceuticals Plant, Snohomish County, Washington State". pharmaceutical-technology.com. Retrieved 12 November 2011.
- "Genzyme and Bayer HealthCare Enter New Strategic Agreement". Genzyme. March 31, 2009. Retrieved 12 November 2011.
- "MedWatch Safety Alerts for Human Medical Products" (PDF). Fda.gov. 2008-11-06. Retrieved 2012-07-07.
- Leukine product website from Genzyme
- Leukine prescribing information
- Leukine Patient information
- Leukine product information