Generic name: Sargramostim
Other names:  GM-CSF, Granulocyte-Macrophage Colony Stimulating Factor

Drug type: Leukine is a biologic response modifier.  Leukine is classified as a colony stimulating factor.  (For more detail, see "How this drug works" section below).

What This Drug Is Used For:

• Used to accelerate the recovery of white blood cells following chemotherapy.
• Used following induction chemotherapy in Acute Myelogenous Leukemia (AML).
• After bone marrow transplantation.
• Before and/or after peripheral blood stem cell transplantation. 
• Sargramostim is a support medication.  It does not treat cancer.

Note:  If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How This Drug Is Given:

• As an injection under the skin (subcutaneous, SubQ).
• As an infusion into the vein (intravenous, IV).
• How it is given depends on why you are receiving this drug.
• The amount of sargramostim that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated.  Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of sargramostim:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration. 
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
• Sargramostim is a support medication.  The following list includes side effects attributed to sargramostim. Other side effects experienced were attributed to the chemotherapy and/or the disease.

The following side effects are common (occurring in greater than 30%) for patients taking Leukine:

• With the first dose of sargramostim a person may experience low blood pressure, fast heart rate, flushing, lightheadedness or feeling faint.  This is referred to as "first-dose effect," and tends not to happen with future doses.
• Diarrhea.
• Local reactions at the injection site. (swelling, redness and tenderness)  
• Weakness and fatigue

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Leukine:

• Mild flu-like syndrome (fever, headache, generalized aches and pains, weakness and fatigue).
• Swelling in your hands and feet.

A rare (< 1%) but significant side effect is problem with blood clots.  Blood clots rarely can lead to pulmonary embolus or stroke - potentially life-threatening conditions.

Another serious, but very uncommon side effect of sargramostim is "capillary leak syndrome" or "vascular leak syndrome."  Capillary leak syndrome is a potentially serious disease in which fluids within the vascular system (veins and capillaries) leaks into the tissue outside the bloodstream.  This results in low blood pressure and poor blood flow to the internal organs.  Capillary leak syndrome is characterized by the presence of 2 or more of the following 3 symptoms; low blood pressure, swelling, and low levels of protein in the blood.  Your doctor will monitor these things carefully while you are taking sargramostim.   You should notify your doctor immediately if you notice dizziness (especially when changing position), sudden swelling or rapid weight gain, little or no urine output (for 8-12 hours), shortness of breath, difficulty breathing, irregular heartbeats, or chest pain.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here.  However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Seek emergency help immediately and notify your health care provider, it you experience the following symptoms:

• Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C) or higher, chills (possible signs of infection)
• Dizziness (especially when changing position), sudden swelling or rapid weight gain, little or no urine output (for 8-12 hours), shortness of breath, difficulty breathing, irregular heartbeats, or chest pain.

The following symptoms require medical attention, but are not an emergency.  Contact your health care provider within 24 hours of noticing any of the following:

• Diarrhea (4-6 episodes in a 24-hour period)
• Extreme fatigue (unable to carry on self-care activities)
• Swelling, redness and/or pain in one leg or arm and not the other

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting sargramostim treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking sargramostim.
• Sargramostim must be given at least 24 hours after the last dose of chemotherapy and 12 hours after radiation therapy.  
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment.  Pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus).
• For both men and women: Do not conceive a child (get pregnant) while taking sargramostim. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.

Self-Care Tips:

• Injection tips:
  • Allow sargramostim to come to room temperature before injecting. 
  • Rotate injection sites. 
  • Do not rub the skin before or after injections.
  • Apply ice to the site for 1 minute immediately prior to injecting.
  • Inject slowly. 
  • Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• If you are taking sargramostim for low white blood cells following chemotherapy, you may be at risk of infection so try to avoid crowds or people with colds and those not feeling well, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• For flu-like symptoms, keep warm with blankets and drink plenty of liquids.
• Acetaminophen or ibuprofen may help relieve discomfort from fever, headache and/or generalized aches and pains.  However, be sure to talk with your doctor before taking it.
• Get plenty of rest. 
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking sargramostim, to monitor side effects and check your response to therapy.  Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.   

How This Drug Works:

Colony-Stimulating Factors:
In the body's bone marrow (the soft, sponge-like material found inside bones) blood cells are produced.  There are three major types of blood cells; white blood cells, which fight infection; red blood cells, which carry oxygen to and remove waste products from organs and tissues; and platelets, which enable the blood to clot.  Cancer treatments such as chemotherapy and radiation therapy can effect these cells which put a person at risk for developing infections, anemia and bleeding problems.  Colony-stimulating factors are substances that stimulate the production of blood cells and promote their ability to function.   They do not directly affect tumors but through their role in stimulating blood cells they can be helpful as support of the person's immune system during cancer treatment.

Sargramostim is a growth factor that stimulates the production, maturation and activation of three types of white blood cells (WBC): neutrophils, macrophages and dendritic cells.  Each of these three cells has a distinct purpose and function within the immune system.  Neutrophils are the most abundant WBC and are the first to respond to the site of an infection.  Their purpose is to capture and digest foreign invaders such as bacteria.  Macrophages also capture and digest foreign invaders but are longer acting and recognize more invaders than neutrophils.  Dendritic cells make up less than 1% of WBC's but are extremely important.  They continuously scan their environment and alert other cells when they find something foreign such as an infection.

For patients receiving chemotherapy, sargramostim can accelerate the recovery of these white blood cells that can then enhance recovery.  Sargamostim is also used to stimulate the early stem cells prior to harvesting for peripheral stem cell transplant, and stimulate recovery of bone marrow cells after bone marrow transplantation.

Note:  We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.  

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