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.

Learning About The Immune System

This section of Leukine.com is intended to provide you with a general understanding of the cells of the immune system and the role they play in fighting infections. Once you have reviewed the information here, you should consider visiting the pages on the site that discuss what cancer therapy does to the immune system.

How the Immune System Works

Your immune system is a complex network of cells that work together to protect your body against "foreign" or invading cells, including abnormal cells that can lead to cancer. Most foreign invaders are germs — infection-causing organisms that you may come into contact with, such as bacteria, viruses, and fungi. Your immune cells are constantly on guard and ready to go into action to detect and destroy these invaders.

Your immune system can recognize millions of different enemies and produce secretions and cells to wipe out each of them. The secret to your immune system's success is its complex and exciting communications network. Tens of millions of cells, organized into groups, pass information back and forth, much like bees do when they swarm. When one group of immune cells discovers the presence of foreign invaders, it undergoes key changes and produces powerful chemical substances. These substances allow the cells to regulate their own growth and function, enlist other immune cells, and direct them to attack the foreign invaders as well.

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How Immune Cells Distinguish Between Foreign Cells and Normal Cells

Your immune system has an amazing ability to distinguish between your body's own cells (referred to as " self") and foreign cells (" nonself"). Each cell carries protein markers called antigens that identify it as self or nonself. Your body's immune system coexists peacefully with all cells that carry the self marker (except in the case of rare autoimmune diseases where the body mistakes self for nonself). This includes bacteria, fungi, viruses, transplanted tissues or cells from another person (except an identical twin), and abnormal cells that can lead to cancer.

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Key Immune System Cells and Their Functions

All immune cells are white blood cells (WBCs) that arise from a single pluripotent stem cell, which is found in bone marrow. When a pluripotent stem cell divides, it forms two daughter cells. These either remain pluripotent stem cells and replenish the pluripotent stem cell pool, or they become specialized immune cells with dedicated functions. Some of these immune cells will become part of the myeloid lineage, which generates cells such as neutrophils, monocytes /macrophages, and dendritic cells. Others will become part of the lymphoid lineage, which gives rise to T cells and B cells.

Your immune system stockpiles a huge arsenal of cells. Some immune cells can destroy many foreign invaders, while others are activated to attack and destroy only specific targets. In order for your immune system to work effectively, your immune cells must not only communicate, but also cooperate with each other. In the following pages we will identify the key cells of the immune system and describe how they work together to fight infection.

Immune Cell Lineage

Immune Cell Lineage

Immune Cell Lineage

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Neutrophils—

Neutrophils are the most abundant type of WBC and are the first immune system cells to rush to the site of an infection.  Neutrophils  are known as phagocytes, or "cell eaters," because they engulf foreign organisms and use prepackaged chemicals to destroy them. Although neutrophils are rapidly produced by your immune system, they live and work for a relatively short period of time — usually just a few days.

Neutrophil

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Monocytes and macrophages—

Monocytes and macrophages are related to neutrophils and are also phagocytes, which destroy foreign organisms by ingesting them. Monocytes are produced by the bone marrow and released into the bloodstream. Some monocytes enter your tissues, then enlarge and mature into macrophages, or "big eaters." macrophages play many important roles within your immune system. As scavengers, they rid your body of worn-out cells and other debris. They also secrete a wide range of powerful, antigen-destroying chemicals and work to "activate" other immune cells through a process called antigen presentation (which is described later in this brochure).

Although they are not as abundant as neutrophils, Monocytes and macrophages can recognize and destroy more types of foreign invaders, including viruses. Also, while neutrophils have a very short lifespan, macrophages can remain in the tissues for months or even years. They act as lookouts, watching for invaders. When necessary they can also direct other immune cells, such as neutrophils, to the site of an infection.

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Monocyte Macrophage

Dendritic Cells—

Although dendritic cells are the least abundant type of WBC, they are the most potent, and are found in your blood and in most tissues throughout your body. Dendritic cells are regulators or "coaches" of the immune system. They act as observers and messengers who go to the battle site, collect pertinent information, and pass it along.

Dendritic cells have long, fingerlike projections that increase their size, improve their mobility to move around, and increase their ability to find and sample more antigens. They collect information about the infection or invasion by identifying the type and the location of the invader.

Dendritic cells are unique because they are capable of capturing and absorbing many types of foreign antigens. Once they capture the antigens, dendritic cells migrate to the lymph nodes, where they use the captured antigens to "activate" large numbers of T cells through antigen presentation. This activation process tells the T cells how to respond. Thus, dendritic cells dictate how other parts of the immune system should react. Dendritic cells are often called "professional" antigen-presenting cells because they do it better than any other type of immune cell.

Dendritic Cell

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T cells

There are two main kinds of T cells: helper T cells and cytotoxic T cells (also known as killer T cells). Helper T cells direct and regulate your body's immune responses, while killer T cells directly attack cells that are infected or cancerous. In order for T cells to do their job, however, they must be "activated" by other immune cells, such as macrophages and dendritic cells.

Killer T Cell Helper T Cell

Upon activation, T cells mature to become either killer T cells or helper T cells.

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B cells—

B cells produce antibodies, which are proteins that bind to antigens and mark them for destruction. B cells are activated when a T cell presents an antigen to them. The B cells then begin producing antibodies that bind specifically to that antigen, which is similar to the way a key matches a lock. Activated B cells also begin multiplying, which further increases the body's immune response.

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How the Immune System Responds to Infection

Once foreign cells enter your body, your immune system fights them using two armies of cells: nonspecific cells (also known as innate immunity) and specific cells (also known as adaptive immunity). Some immune cells have multiple functions and therefore may be considered both nonspecific and specific.

Neutrophils, macrophages, and dendritic cells are critical immune cells because they attack foreign invaders of all kinds. These cells are also critical because they circulate continuously within your body looking for any foreign antigen.

Your body also uses specific immune cells to fight infection. These specific cells can't distinguish between self and nonself and therefore only go into action when nonspecific cells (such as macrophages and dendritic cells) give them information about new invaders through antigen presentation.

Antigen presentation is an amazing and highly effective process. When macrophages and dendritic cells attack and destroy a foreign antigen, they capture a portion of it and then present it to your body's T cells. In doing this, the antigen-presenting cells "activate" certain T cells to aggressively seek out and destroy all foreign invaders that carry that specific antigen. Other T cells can further activate other parts of the adaptive immune system to also destroy the specific foreign antigen.

It is through this and other complex processes that your body's immune cells work together to destroy foreign invaders and successfully fight off infection.

Antigen, T cell, B cell, Antibody

Antigen, T cell, B cell, Antibody

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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.