Leukine (Sargramostim) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Leukine

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Cancer is the uncontrolled growth of abnormal cells anywhere in a body. The abnormal cells are termed cancer cells, malignant cells, or tumor cells. Many cancers and the abnormal cells that compose the cancer tissue are further identified by the name of the tissue that the abnormal cells originated from (for example, breast cancer, lung cancer, colon cancer). Cancer is not confined to humans; animals and other living organisms can get cancer. Below is a schematic that shows normal cell division and how when a cell is damaged or altered without repair to its system, the cell usually dies. Also shown is what can occur when such damaged or unrepaired cells do not die and become cancer cells and proliferate with uncontrolled growth; a mass of cancer cells develop. Frequently, cancer cells can break away from this original mass of cells, travel through the blood and lymph systems, and lodge in other organs where they can again repeat the ...

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Leukine

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LEUKINE®
(sargramostim)

DRUG DESCRIPTION

LEUKINE® (sargramostim) is a recombinant human granulocyte macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells. LEUKINE (sargramostim) is a glycoprotein of 127 amino acids characterized by three primary molecular species having molecular masses of 19,500, 16,800 and 15,500 daltons. The amino acid sequence of LEUKINE (sargramostim) differs from the natural human GM-CSF by a substitution of leucine at position 23, and the carbohydrate moiety may be different from the native protein. Sargramostim has been selected as the proper name for yeast derived rhu GM-CSF.

The liquid LEUKINE (sargramostim) presentation is formulated as a sterile, preserved (1.1% benzyl alcohol), injectable solution (500 mcg/mL) in a vial. Lyophilized LEUKINE (sargramostim) is a sterile, white, preservative free powder (250 mcg) that requires reconstitution with 1 mL Sterile Water for Injection, USP or 1 mL Bacteriostatic Water for Injection, USP. Liquid LEUKINE (sargramostim) has a pH range of 6.7 - 7.7 and lyophilized LEUKINE (sargramostim) has a pH range of 7.1 - 7.7.

Liquid LEUKINE (sargramostim) and reconstituted lyophilized LEUKINE (sargramostim) are clear, colorless liquids suitable for subcutaneous injection (SC) or intravenous infusion (IV). Liquid LEUKINE contains 500 mcg (2.8 x 10⁶ IU/mL) sargramostim and 1.1% benzyl alcohol in a 1 mL solution. The vial of lyophilized LEUKINE (sargramostim) contains 250 mcg (1.4 x 10⁶ IU/vial) sargramostim. The liquid LEUKINE (sargramostim) vial and reconstituted lyophilized LEUKINE (sargramostim) vial also contain 40 mg/mL mannitol, USP; 10 mg/mL sucrose, NF; and 1.2 mg/mL tromethamine, USP, as excipients. Biological potency is expressed in International Units (IU) as tested against the WHO First International Reference Standard. The specific activity of LEUKINE (sargramostim) is approximately 5.6 x 10⁶ IU/mg.

What are the possible side effects of sargramostim (Leukine)?

If you experience any of the following serious side effects, stop using sargramostim and seek emergency medical treatment or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
dizziness or fainting;
a fever (over 100.5 degrees Fahrenheit or 38 degrees Celsius);
signs of infection including chills, sore throat, or congestion or redness, pain, or swelling around a wound or sore;
swelling of...

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What are the precautions when taking sargramostim (Leukine)?

Before using sargramostim, tell your doctor or pharmacist if you are allergic to it; or to other medications made in a similar manner (man-made proteins using Saccharomyces cerevisiae); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: fluid retention, lung problems, heart problems (e.g., congestive heart failure-CHF, rhythm problems), liver disease, kidney disease, other blood disorders (e.g., myeloid cancers), current chemotherapy.

If you are scheduled to have radiation therapy, tell your doctor you are taking sargramostim....

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Last reviewed on RxList: 8/12/2008
This monograph has been modified to include the generic and brand name in many instances.