"The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
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)?
Some people receiving a sargramostim injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- high fever, chills, sore...
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....
Last reviewed on RxList: 8/12/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Leukine Information
Leukine - User Reviews
Leukine User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.