Sargramostim

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Sargramostim
Systematic (IUPAC) name
Human granulocyte macrophage colony stimulating factor
Clinical data
AHFS/Drugs.com monograph
MedlinePlus a693005
Legal status
  • ℞ (Prescription only)
Identifiers
CAS Number 83869-56-1 YesY
ATC code L03AA09 (WHO)
DrugBank DB00020 YesY
UNII 5TAA004E22 YesY
ChEMBL CHEMBL1201670 N
Chemical data
Formula C639H1006N168O196S8
Molecular mass 14434.5 g/mol
 NYesY (what is this?)  (verify)

Sargramostim (marketed by Genzyme under the tradename Leukine) is a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) that functions as an immunostimulator.[1]

It is produced in yeast.[2]

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 disorders. This medication is being investigated in trials to treat Autoimmune Pulmonary Alveolar Proteinosis (PAP).[3] It is also being investigated in combination with oncolytic reovirus in brain cancer. [4]

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. 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.[5][6][7]

Liquid formulation - withdrawn

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 The liquid formulation was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change[when?] 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.[8] The original liquid formulation (without EDTA) was returned to the market in the US shortly[when?] after the EDTA-containing liquid formulation was withdrawn[when?].[citation needed]

References

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External links

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