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.

What Cancer Does

This section of Leukine.com discusses the effect that cancer treatments have on immune system cells and the resulting infection risks.

The Immune System and Cancer Treatments

Cancer treatments can temporarily weaken your immune system. Chemotherapy and radiation therapy, which target and destroy fast-growing cancerous cells, can also kill healthy cells. Because some infection-fighting white blood cells (WBCs) are also fast-growing, they may be affected by chemotherapy and radiation therapy.

Stem cell transplantation (from bone marrow or peripheral blood) is another type of cancer treatment that can compromise your immune system. A transplant may be performed if your bone marrow has been damaged and cannot make some or all of the blood cells your body needs. Damage to the bone marrow may be a result of disease that affects the bone marrow itself, or it may result from intense anticancer therapies.

During stem cell transplantation, healthy pluripotent stem cells are harvested (from a donor or from the patient) and then infused into the patient. It takes time for these new or reinfused cells to repopulate the body and establish normal immune system functions. During this time your body is at greater risk for infection.

Cancer Treatments and the Risk of infection

After chemotherapy, radiation therapy, or stem cell transplantation, your healthcare team will closely monitor your immune system, using blood tests that measure the levels of various cell types. As part of this process, they will monitor your absolute neutrophil count (ANC), which is an important marker that can indicate your risk of infection. Your ANC refers to the number of neutrophils in your blood. Neutrophils are monitored because they are the most abundant type of WBC, and are the first to rush to the site of an infection and attack foreign antigens. If the number of neutrophils in your body is abnormally low (a condition called neutropenia), it is an indication that your body may be unable to successfully defend itself against infection. An increased risk of infection occurs once the number of neutrophils drops below 1000 and especially below 500. Following cancer therapy, your doctor will monitor the number of white blood cells (WBCs) in your blood with regular blood tests to determine when the WBCs reach a level that is high enough to help fight infections.

Other cells of the immune system, such as macrophages and dendritic cells, are also very important in regard to infection risk. However, they are not measured and used as markers because they are not nearly as abundant as neutrophils.

As your healthcare team monitors your immune system following cancer treatment, remember that it is important for you to do everything possible to reduce your risk of infection. An infection of any kind can disrupt your cancer treatment and, in severe cases, may require hospitalization.

Absolute Neutrophil Count
Absolute Neutrophil Count

In order to offer adequate protection from infection, your ANC should be around 1500 cells per mm3.1 Risk of infection increases when your ANC drops below 1000 cells per mm3 and especially below 500 cells per mm3.

Treatments to Help Boost the Immune System and Fight Infection

Antibiotics are used to treat an infection once it occurs and are sometimes given to prevent infections. In addition, there are other types of drugs available that can help your immune system recover more quickly from cancer treatment, thereby reducing the risk of infection. One of these drugs is Leukine (sargramostim), which is prescribed in certain instances described below to help raise your ANC3.

Leukine is approved for use following induction chemotherapy in older adults with acute myelogenous leukemia, after bone marrow transplantation, before and/or after peripheral blood stem cell transplantation, and for bone marrow transplantation failure or engraftment delay.2

Clinical studies have shown that Leukine significantly reduced the incidence and severity of infections in older patients who received Leukine following induction chemotherapy for acute myelogenous leukemia. 3,4 Clinical studies have also shown that Leukine reduced the incidence of infections in patients who received autologous (cells from the patient) and allogeneic (cells from a donor) bone marrow transplantation.

Patients who take Leukine may experience unwanted side effects, most of which are mild to moderate. Some common side effects include bone pain; a slight temperature elevation (usually less than 100.5°F or 38°C) for one to four hours after injection; and swelling, redness, and/or discomfort at the injection site. Skin reactions may occur because cells of the immune system, such as macrophages, are drawn to the injection site. Clinical studies have shown that Leukine significantly reduced the incidence and severity of infections in older patients who received Leukine following induction chemotherapy for acute myelogenous leukemia.3,4 Clinical studies have also shown that Leukine reduced the incidence of infections in patients who received autologous (cells from the patient) and allogeneic (cells from a donor) bone marrow transplantation.2,5,6 You may also feel tired or weak, experience muscle aches, have diarrhea, experience stomach upset, or feel like you have the flu. Some side effects or symptoms may be serious. These may be due to Leukine®, your illness, or other treatments you may have received. Call your doctor immediately if any of the following happen to you: you develop a high fever (over 100.5° F or 38° C), you notice any signs of infection including chills, sore throat, or congestion (such as a stuffy nose), you have trouble breathing, or you develop wheezing, fainting, extensive skin rash, hives, or feel you are having an allergic reaction, you experience sudden weight gain or other signs of fluid build-up such as swollen legs or feet, you develop chest pain, chest discomfort, or a rapid or irregular pulse. If you are concerned about any other side effects or symptoms you may be having, contact your doctor, nurse,or pharmacist.

About Leukine

As part of your cancer treatment, Leukine may be prescribed by your doctor to help your body's immune system recover. Leukine is a man-made form of a colony-stimulating factor (CSF). A CSF is a type of protein also known as a growth factor. Your body makes this protein when it is functioning normally to help increase the number and function of your WBCs.

Because Leukine increases your body's production of three types of WBCs (neutrophils, monocytes/ macrophages, and myeloid-derived dendritic cells), it may help activate your body's natural defenses against multiple types of infectious organisms, including bacteria, fungi, and viruses.4,5,7

Immune Cells Stimulated by Leukine

Leukine provides enhanced protection against infection by stimulating cells that activate additional immune system responses.

GM-CSF Stimulates
GM-CSF Stimulates

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.