Sargramostim (Leukine®, GM-CSF)
Classification: Colony Stimulating Factor
About Sargramostim (Leukine®, GM-CSF)
Sargramostim is a man-made version of GM-CSF, which stimulates white blood cell production, and in particular, neutrophil, macrophage, and dendritic cell production. These types of cells are responsible for fighting infection and are often decreased during cancer therapy.
Neutrophils are the most abundant type of white blood cell and are the first to respond to fight infection. When the number of these neutrophils drops below 1000/mm3, it is called neutropenia, and puts the patient at significant risk of infection. Macrophages fight infection by ingesting bacteria, but are longer acting than neutrophils. Dendritic cells make up only 1% of white blood cells, but are constantly scanning the area, notifying neutrophils and macrophages when they detect infection.
How to Take Sargramostim
Sargramostim can be given as a subcutaneous injection (given under the skin), or directly into a vein (intravenous, IV). It is given once a day, preferably at the same time of day, until the neutrophil count returns to normal. The actual dose is determined by your healthcare provider and is based on your body size. Sargramostim should be started no sooner than 24 hours after completion of chemotherapy or radiation. You will have lab work drawn frequently to monitor your blood cell counts while on sargramostim. You may receive this medication in your provider's office, from a home infusion company, or you may be taught to give it to yourself.
Storage and Handling
Store this medication in the refrigerator, in the original container. Do not shake the medication. To lessen the sting of the injection, take it out of the refrigerator 30 minutes prior to administration. Do not reuse single dose vials, syringes or needles.
Do not throw the vials, syringes, or needles in the household trash. Dispose of all used needles and syringes in a puncture-proof disposable container with a lid. The FDA provides further information about the disposal of vials, syringes and needles.
Where do I get this medication?
Depending on your insurance coverage, this medication may be supplied by a home infusion company or through a specialty pharmacy. If covered through your pharmacy plan, your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for distribution of this medication and shipment directly to your home.
Depending on your insurance coverage, this medication may be covered under your major medical plan OR your prescription plan. Your oncology team will work with your insurance company and pharmacy plan to determine who will supply the drug. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay assistance through private, third party foundations may also be available to those who meet income and diagnostic requirements. Your care team can help you find these resources, if they are available.
Possible Side Effects of Sargramostim
There are a number of things you can do to manage the side effects of sargramostim. Talk to your doctor or nurse about these recommendations. They can help you decide what will work best for you. These are some of the most common side effects:
Sargramostim stimulates the bone marrow to produce many white blood cells, which can lead to pain in the bones. This pain is often felt in the bones of the thighs, hips and upper arms. Your healthcare team may not want you to take acetaminophen (Tylenol®) because it can "mask" a fever, so talk to them about what pain relievers you can take.
Sargramostim can cause a low fever, but this could also be a sign of infection. Any fever (temperature > 100.4) should be reported to your healthcare team right away. Be sure you have a contact number for evenings and weekends, when the office is closed.
Injection Site Reactions
Some people experience redness, swelling, or itching at the site of injection. This is usually temporary. The injection is known to sting or burn if given when it is cold. Take the medication out of the refrigerator 30 minutes ahead of time to allow it to come up to room temperature before administration. Rotate the sites where the injection is given, inject slowly and/or numb the area with ice prior to giving the injection.
"First Dose Effect"
Following the first dose of sargramostim, there have been reports of difficulty breathing, flushing, low blood pressure, lightheadedness and elevated heart rate. These symptoms did not occur with future doses, but you should report this to your healthcare team immediately. This reaction is more common with intravenous (IV) administration of the drug.
Other Side Effects
Swelling and fluid retention (which can occur in the lungs or heart) have been reported. Patients receiving this medication should report any shortness of breath, cough, swelling in arms, legs or face to the healthcare team immediately.
There have been reports of breathing problems after the IV infusion and abnormally high heart rate. Notify your provider if you have any new or worsening shortness of breath of feet your heart pounding or beating fast.
The following side effects were also reported in clinical trials: decreased kidney function, elevation of liver enzymes (detected on blood tests) that resolve when the drug is stopped.
It is not known if exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should consult with your healthcare team before breastfeeding while receiving this medication.