sargramostim, Leukine

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GENERIC NAME: sargramostim

BRAND NAME: Leukine

DRUG CLASS AND MECHANISM: Sargramostim is a man-made form of the naturally-occurring protein, granulocyte, macrophage-colony stimulating factor (GM-CSF). GM-CSF is produced in the body by the immune system and stimulates the formation of white blood cells, including the granulocyte and the macrophage. Granulocytes and macrophages take part in the inflammatory reaction. They are responsible for detecting and destroying harmful bacteria and some fungi. Sargramostim belongs to a class of drugs called colony-stimulating factors because of their ability to stimulate cells in the bone marrow to multiply and form colonies. Sargramostim is man-made. It is a product of the genetic engineering of genes from fungi and is produced by recombinant DNA technology in bacteria. Other colony stimulating factors are epoetin alfa (Epogen, Procrit) that stimulate the formation of red blood cells and filgrastim (Neupogen) that also stimulates the formation of granulocytes and macrophages. The FDA approved sargramostim in March 1991.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Injectable Solution: 500 mcg/ml; Powder for Injection: 250 mcg/vial

STORAGE: Sargramostim should be stored at 2 C to 8 C (36 F to 46 F). Sargramostim should not be frozen.

PRESCRIBED FOR: Sargramostim is used to increase the number of white blood cells when the white blood cell count is low, a condition called neutropenia. A reduced level of white blood cells causes an increased susceptibility to infections. Sargramostim is used in cancer patients with non-Hodgkins lymphoma, acute lymphoblastic leukemia and Hodgkins lymphoma who have received a bone marrow transplant to rapidly increase the white blood cell count. It also is used to manage patients with acute myelogenous leukemia over the age of 55 years who develop neutropenia because of chemotherapy. Sargramostim also may be used in cancer patients or healthy patients who have low white blood cell counts to boost the counts and thereby improve the bone marrow they will be donating for use in bone marrow transplantation.

DOSING: Sargramostim is administered intravenously or subcutaneously (under the skin). Sargramostim vials should not be shaken since the drug may be damaged, and bubbles may form that can prevent some of the drug from being drawn up into the syringe at the time of injection. Doses and duration of treatment vary depending on which condition it is used for. 250 mcg/m2/day given by intravenous injection is a typical adult dose for most uses.

DRUG INTERACTIONS: No clinical studies have been done to determine if sargramostim interacts with other drugs.

PREGNANCY: There are no studies of the use of sargramostim in pregnant women.

NURSING MOTHERS: There are no studies to determine if sargramostim is excreted into breast milk.

SIDE EFFECTS: The most common side effects while taking sargramostim are stomach pain, mild to moderate fever, weakness, chills, headache, nausea, vomiting, diarrhea, rash, muscle and bone pain. Shortness of breath, weight loss, leg and arm swelling, and injection site reactions also occur. Sargramostim may cause serious allergic reactions and abnormal heart beats.

Reference: FDA Prescribing Information


Last Editorial Review: 3/20/2013




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