Important Safety Considerations

Leukine® (sargramostim) is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥ 10%), in patients with known hypersensitivity to GM-CSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy.
Click here for additional Important Safety Information.
Click here for Indications.

Glossary of Terms

Absolute neutrophil count (ANC)
Refers to the number of neutrophils in the blood. Healthcare providers use ANC to help monitor the risk of infection in patients undergoing cancer treatment.
Acute lymphocytic leukemia (ALL)
A condition marked by a rapid increase in the number of immature white blood cells called "lymphoblasts," which fail to function as normal cells; leaves the body susceptible to anemia, infection, and bleeding.
Acute myelogenous leukemia (AML)
A condition that occurs in which the infection-fighting white blood cells do not mature fast enough, leaving the body susceptible to anemia and infection.
Acute promyelocytic leukemia (APL)
A subtype of AML. APL patients undergo a different treatment regimen than those with AML.
Allogeneic transplantation
Bone marrow transplantation that utilizes healthy cells harvested from a donor for a patient after he or she undergoes chemotherapy and/or radiation. (see: bone marrow transplant)
Anemia
A condition in which the blood is deficient in red blood cells; can cause fatigue, shortness of breath, and a pale complexion.
Antibiotics
A class of medications used to treat infections.
Antibodies
Proteins produced by B cells that attach to specific antigens and mark them for destruction.
Antigen
Any substance capable of eliciting an immune response.
Antigen presentation
A process wherein certain immune cells (i.e., macrophages and dendritic cells) attack an antigen, capture a portion of it, and present it to T cells, which then aggressively seek out and destroy those specific antigens.
Autologous transplantation
Bone marrow transplantation that utilizes healthy cells harvested from the patient before he or she undergoes chemotherapy and/or radiation. (see: bone marrow transplant)
B cell
A type of immune cell that produces antibodies, which recognize and attack antigens on the surface of foreign cells.
Bacteria
Found in all natural environments, some bacteria can cause diseases in humans.
Blast cell
A white blood cell that fails to mature, multiplies rapidly, and crowds out normal blood cells; inhibits the ability of normal cells to effectively defend the body against microorganisms.
Bone marrow
Nutrient-rich, spongy tissue that is found in the center shafts of certain long, flat bones of the body, such as the bones of the pelvis. Bone marrow produces the pluripotent stem cell from which all immune cells arise.
Bone marrow biopsy
Insertion of a biopsy needle into the hipbone to retrieve a small sample of bone.
Bone marrow sampling (biopsy and aspiration)
A diagnostic procedure that entails removing a sample of bone marrow or fluid from the patient.
Bone marrow transplantation
A procedure for replacing blood-forming cells in the bone marrow that have been destroyed by chemotherapy with healthy bone marrow. Transplantation may be:

* Autologous (the patient's bone marrow saved earlier)
* Allogeneic (bone marrow donated by someone else)
* Syngeneic (bone marrow donated by an identical twin)

Chemotherapy
Oral or intravenous drug treatments given to destroy cancer cells.
Chronic lymphocytic leukemia (CLL)
A slowly progressing condition marked by the proliferation of abnormal white blood cells called lymphocytes; leaves the body susceptible to anemia, infection, and bleeding.
Chronic myelogenous leukemia (CML)
A slowly progressing condition marked by the proliferation of abnormal white blood cells called granulocytes; leaves the body susceptible to anemia, infection, and bleeding.
Clinical trial
A study evaluating the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people.
Colony-stimulating factor (CSF)
A man-made protein very similar to naturally produced proteins in the body that predominantly signal the production of white blood cells.
Complete blood count (CBC)
The number of different types of blood cells (red blood cells, white blood cells, platelets, etc.), in a cubic milliliter of blood.
Consolidation therapy
The second phase of AML treatment after induction chemotherapy; consists of further chemotherapy or stem cell transplantation to kill any remaining leukemia cells.
Corticosteroids
A group of anti-inflammatory drugs whose makeup is similar to the body's own natural hormones.
Cytogenetics
A laboratory evaluation of the chromosomes of cells from the blood, bone marrow, or lymph nodes.
Cytotoxic T cell:
A type of T cell (also known as a killer T cell) that is activated by other immune cells to seek out and destroy specific foreign antigens.
De novo
A condition or disease as "new"; as in newly diagnosed.
Dendritic cells
Immune cells that capture and absorb many types of foreign antigens and also activate T cells.
Engraftment delay
A failure in the bone marrow transplantation procedure.
Erythrocytes
Normal-functioning red blood cells that carry oxygen in the body.
FDA
US Food and Drug Administration. Federal regulatory body charged with evaluating and approving for use and consumption drugs, medical devices, and food products.
Fungi
Organisms that can cause a number of diseases in humans, including ringworm and athlete's foot.
Gastrointestinal tract
The organ system of the body that includes the stomach and intestines.
Granulocyte
A type of white blood cell produced in the bone marrow.
Head and neck radiation
Radiation therapy delivered to the head and neck area to destroy cancer cells in that area.
Helper T cell
A type of T cell that does not directly kill foreign cells, but instead directs and regulates your body's immune responses.
Hematopoietic cells
Blood-forming cells produced in the bone marrow.
Hemoglobin
A protein carried by red blood cells that picks up oxygen in the lungs and carries it to tissues in the body.
Induction chemotherapy
The first stage in treatment where chemotherapy is used to reduce the number of cancer cells.
Leukemia
A form of cancer that affects the blood-forming cells of the bone marrow; literally means "white blood" in Greek.
Leukocyte
A white blood cell that defends the body against viruses and bacteria.
Lymph nodes
Rounded masses of tissue that produce lymphocytes and filter the flow of lymph, the pale fluid that bathes the tissues of the body.
Lymphocytic leukemia
Leukemia that develops in the lymphoid cell lines.
Lymphoid
One of two immune cell lineages that are derived from the pluripotent stem cell. The lymphoid lineage gives rise to all lymphoid cells, including T cells and B cells.
Macrophage
A type of immune cell found in the body's tissues and organs. Macrophages rid the body of worn-out cells and other debris, secrete powerful antigen-destroying chemicals, and play an important role in activating T cells.
Monocyte
A type of immune cell that circulates in the blood and becomes a macrophage when it enters the body's tissues and organs.
Mucosa
The moist surface tissues that line the mouth, throat, stomach, intestines, and rectum.
Mucositis
A side effect of chemotherapy that causes inflammation of the mucosal tissues that line the mouth, throat, stomach, intestines, and rectum.
Myelogenous leukemia
Leukemia that develops in the myeloid cell lines.
Myeloid
One of two immune cell lineages that are derived from the pluripotent stem cell. The myeloid lineage generates all myeloid cells, including neutrophils, monocytes/macrophages, and dendritic cells.
Myeloid-derived dendritic cell
A type of white blood cell that captures and absorbs many types of foreign antigens and also activates T cells.
Neutropenia
A condition that occurs when the number of neutrophils in your body is abnormally low, resulting in an increased risk of infection.
Neutrophil
An immune cell that ingests and degrades foreign organisms. Neutrophils are the most abundant type of white blood cells, and are the first to rush to the site of an infection and attack foreign antigens.
Nonself
A concept used to explain the immune system's ability to distinguish foreign cells from the body's own cells. All foreign molecules carry markers that identify them as "nonself."
Nonspecific immunity
The body's immediate response against foreign invaders, wherein certain immune cells rapidly attack foreign antigens of all kinds. Also referred to as innate immunity.
Peripheral blood
The blood that flows through the blood vessels and heart.
Peripheral blood stem cell transplantation
A method of replacing blood-forming cells destroyed by cancer treatment. Also called peripheral stem cell support. Immature blood cells in the circulating blood that are similar to those in the bone marrow are given to the patient after treatment to help the bone marrow recover and continue producing healthy blood cells. Transplantation may be:

* Autologous (the patient's blood cells saved earlier)
* Allogeneic (blood cells donated by someone else)
* Syngeneic (blood cells donated by an identical twin)
Phagocytes
Immune cells that engulf and destroy foreign invaders. Examples of these types of phagocytes are monocytes, macrophages, and neutrophils.
Platelet
A type of cell that causes the blood to clot.
Pluripotent stem cell
The cell produced in bone marrow from which all immune cells arise.
Pyrogen
A substance causing fever.
Radiation therapy
The use of high-energy rays directed to a specific area of the body or the entire body to reduce cancer cells.
Secondary AML
Acute myelogenous leukemia that sometimes occurs in patients who have undergone previous chemotherapy; more prevalent in elderly patients.
Self
A concept used to explain the immune system's ability to distinguish the body's own cells from foreign cells. The immune system coexists peacefully with every cell in the body that carries marker molecules that identify it as "self."
Side effects
Problems that occur that are different from — or in addition to — a treatment's desired therapeutic effect.
Specific immunity
The body's response to foreign invaders, wherein certain immune cells are "activated" and adapt to defend against specific foreign antigens. Also referred to as adaptive immunity.
Stem cells
The cells that are responsible for making all of the blood cells in the body.
Stem cell transplantation
A procedure in which a patient intravenously receives healthy stem cells (from the patient's own blood or a matched donor), which will begin producing normal blood cells.
Thrombocytopenia
A persistent decrease in the number of blood platelets; people with too few platelets may bleed easily, heal slowly, and bruise often.
T cell
A type of immune cell that produces special molecules that allow them to recognize and react to foreign antigens. The two main kinds of T cells are cytotoxic T cells (also known as killer T cells) and helper T cells.
Virus
An infectious agent of small size and simple composition that can multiply only in living cells of animals, plants, or bacteria.
White blood cells (WBCs)
The cells that make up your immune system and originate from the pluripotent stem cell; cells made by the body to fight infection.

Leukine Resources

Indication

Leukine® (sargramostim) is used to help increase the number and function of white blood cells after bone marrow transplantation, in cases of bone marrow transplantation failure or engraftment delay, before and after peripheral blood stem cell transplantation, and following induction chemotherapy in older patients with acute myelogenous leukemia. Your doctor may also choose to treat other conditions with Leukine.

Important Safety Information for Leukine® (sargramostim)

  • You should not use Leukine if you have high levels of abnormal white blood cells, called leukemic blasts, in the bone marrow or blood. You should not use Leukine® if you have had an allergic reaction to GM-CSF, other products made from yeast, or any ingredient used to make Leukine. If you are also receiving chemotherapy or radiation therapy, do not take your Leukine in the period 24 hours before through 24 hours after the administration of your chemotherapy or radiation therapy.
  • A generalized allergy is an uncommon but potentially serious reaction to Leukine. This may include askin rash over your entire body, hives, trouble breathing, a fast pulse, sweating, and feeling faint. In severe cases a generalized allergy may be life-threatening. If you think you are having a generalized allergy to Leukine, stop taking Leukine and notify your doctor immediately.
  • Liquid solutions containing benzyl alcohol, including Leukine liquid or lyophilized Leukine reconstituted with Bacteriostatic Water For Injection, USP should not be administered to newborns.
  • Leukine should be used with caution, and your doctor should monitor you if you have preexisting fluid buildup, heart or lung conditions, or kidney or liver disease.
  • Some patients taking Leukine may experience unwanted side effects, most of which are mild to moderate and not serious. Some of the more common side effects include bone pain, feeling like you have the flu, feeling tired or weak, muscle aches, diarrhea, stomach upset, weight loss, or loss of appetite. You may also get a low-grade fever (less than 100.5°F or 38°C) about 1 to 4 hours after an injection, or you may have swelling, redness, and/or discomfort where Leukine was injected.
  • Some side effects or symptoms may be serious. These include developing a high fever (over 100.5°F or 38°C), signs of infection including chills, sore throat, or congestion (such as stuffy nose), having trouble breathing, wheezing, or fainting, or developing extensive skin rash, hives, or other signs of an allergic reaction, experiencing sudden weight gain or other signs of fluid buildup, such as swollen legs or feet, having chest pain, chest discomfort, or a rapid or irregular pulse. These may be due to Leukine, your illness, or other treatments that you may have received. Many of these side effects can be reduced or eliminated. These or other side effects you may be concerned about should be reported promptly to your doctor, nurse, or pharmacist.
  • Your doctor will monitor your white blood cell and platelet counts with blood tests during Leukine treatment. If your white blood cell or platelet counts rise above certain levels, your doctor may stop your Leukine treatment, or may reduce the dose. If your doctor detects progression of your disease, he/she may stop your Leukine therapy.
  • Drugs that can increase WBCs, such as lithium and corticosteroids, should be used with caution while receiving Leukine Interactions between Leukine and other drugs have not been fully evaluated.

Please see full Prescribing Information.