Sargramostim

Sargramostim

drugbox
IUPAC_name=Human granulocyte macrophage colony stimulating factor


CAS_number=83869-56-1
ATC_prefix=L03
ATC_suffix=AA09
ATC_supplemental=
PubChem=
DrugBank=BTD00035
C=639|H=1006|N=168|O=196|S=8
molecular_weight=14434.5 g/mol
bioavailability=
protein_bound=
metabolism=
elimination_half-life=
excretion=
pregnancy_AU=
pregnancy_US=
pregnancy_category=
legal_AU=
legal_UK=
legal_US=
legal_status=Rx only
routes_of_administration=

Sargramostim (marketed by Bayer under the tradename Leukine) is a recombinant granulocyte macrophage colony-stimulating factor which functions as a immunostimulator.cite journal |author=Kirman I, Belizon A, Balik E, "et al" |title=Perioperative sargramostim (recombinant human GM-CSF) induces an increase in the level of soluble VEGFR1 in colon cancer patients undergoing minimally invasive surgery |journal= |volume= |issue= |pages= |year=2007 |pmid=17512160 |doi=10.1016/j.ejso.2007.03.014]

It is produced in yeast.cite journal |author=Beveridge RA, Miller JA, Kales AN, "et al" |title=A comparison of efficacy of sargramostim (yeast-derived RhuGM-CSF) and filgrastim (bacteria-derived RhuG-CSF) in the therapeutic setting of chemotherapy-induced myelosuppression |journal=Cancer Invest. |volume=16 |issue=6 |pages=366–73 |year=1998 |pmid=9679526 |doi=]

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.

Contraindications

Sargramostim should not be used in patients with 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 The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the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. [http://www.fda.gov/medwatch/safety/2008/Leukine_DHCP_01-23-2008.pdf]

References

External links

* [http://www.leukine.com/hcp/index.jsp Leukine product website] from Bayer
* [http://berlex.bayerhealthcare.com/html/products/pi/Leukine_PI.pdf Leukine prescribing information]


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