Leukine (sargramostim) helps your body grow new blood cells or recover from low blood cell counts. This can help lower your risk of other complications, such as infection. Leukine (sargramostim) can be used after certain types of chemotherapy, bone marrow transplant, or radiation. It's given as an injection daily, either through the veins or under the skin. This medication is only available as a brand name, there's currently no lower-cost generic version. Common side effects of Leukine (sargramostim) include fever, diarrhea, and lack of energy.
Growth or recovery of new blood cells after:
Chemotherapy to treat certain types of blood cancers (adults age 55 years and older)
Bone marrow transplant (adults and children ages 2 years and older)
To prepare the body for stem cell collection for stem cell transplant (adults only)
Raise the chance of survival after exposure to acute radiation (adults and children)
Leukine (sargramostim) is a granulocyte-macrophage colony-stimulating factor (GM-CSF). It works like the naturally occurring GM-CSF protein in your body to stimulate (trigger) bone marrow to make neutrophils, a type of white blood cell that helps your body fight infections.
Source:Â DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Black, tarry stools
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the eye
bloody nose
blurred vision
body aches or pain
bone pain
cloudy urine
congestion
decrease in urine output or decrease in urine-concentrating ability
difficult or labored breathing
drowsiness
dryness or soreness of the throat
fast, pounding, or irregular heartbeat or pulse
flushed, dry skin
fruit-like breath odor
hoarseness
increased hunger
increased thirst
increased urination
irregular heartbeat
large amount of cholesterol in the blood
loss of appetite
mood or mental changes
rapid weight gain
redness in whites of eyes
stomach pain
sweating
tender, swollen glands in the neck
tightness in the chest
tingling of the hands or feet
trouble with swallowing
trembling
twitching
unusual tiredness or weakness
unusual weight gain or loss
voice changes
vomiting
vomiting of blood or material that looks like coffee grounds
yellow eyes or skin
Incidence not known
Chills
confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
general feeling of illness
headache
pain in the chest, groin, or legs, especially the calves
severe, sudden headache
slurred speech
sudden loss of coordination
sudden, severe weakness or numbness in the arm or leg
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
difficulty in moving
fear or nervousness
itching skin
lack or loss of strength
muscle pain or stiffness
pain in the joints
trouble sleeping
Incidence not known
Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
feeling of warmth
redness of the face, neck, arms, and occasionally, upper chest
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Stimulates the growth of many different cells
When used for exposure to radiation, it can be used in people of all ages
Doesn't have a risk of ruptured spleen or sickle cell crisis like G-CSF medications (e.g., Neupogen (filgrastim))
Can only be used after induction chemotherapy for AML in people age 55 years and older
Can cause bone pain
Not available as a generic
You might be able to receive Leukine (sargramostim) at home if your healthcare provider says it's safe to do so. If you're going to inject the medication at home, make sure you or your caregiver understand how to use the medication properly before leaving your provider's office.
Don't change your dose or stop this medication without first talking to your provider.
Leukine (sargramostim) shouldn't be given within 24 hours of chemotherapy or radiation. Make sure you know your treatment schedule and know when you should administer Leukine (sargramostim)
If you miss or forget your dose, contact your provider for further instructions.
Store Leukine (sargramostim) in the refrigerator (not in the freezer). Keep it in its original container to protect it from light, and don't shake it.
Check each vial before using the medication. Don't inject if Leukine (sargramostim) contains any particles (solid chunks), flakes, is discolored, or foamy.
Once the vial of Leukine (sargramostim) is opened, it can be kept in the refrigerator for 20 days. It can be helpful to write the date that you first used the vial or the date it will expire. Discard any remaining solution after 20 days.
Don't reuse needles, and throw them away in a sharps container after use to prevent needlestick injuries.
Leukine (sargramostim) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Leukine (sargramostim) can cause infusion reactions after the first dose in any given cycle. Symptoms include trouble breathing, flushing, low blood pressure, fainting, and/or fast heartbeat. Your healthcare team will monitor for signs of this reaction and might slow down your infusion rate if you start to show symptoms. Usually symptoms don't happen again after the first dose within each cycle.
Additionally, Leukine (sargramostim) can cause serious allergic reactions. Get medical help right away if you notice a rash, swelling in your face or throat, or trouble breathing.
Risk factors: History of fluid retention | Heart failure
Though not common, Leukine (sargramostim) can cause capillary leak syndrome (CLS) or swelling. Your provider will keep track of your body weight during treatment. Talk to your provider if you notice dizziness, lightheadedness, or unexplained swelling in your body or weight gain. If so, your provider might need to pause or lower the dose of Leukine (sargramostim) , or give you a water pill to ease swelling.
Risk factors: History of heart arrhythmia
There have been reports of people taking Leukine (sargramostim) who have had changes in their heartbeat. It's more common in people who have a history of irregular heartbeats and will usually go away after the medication is stopped.
Leukine (sargramostim) is a growth factor, which means there's a possibility for it to promote the growth of other tumors (myeloid cell lines). Your providers will monitor your labs closely and might stop the medication if the risks become greater than the benefits.
Risk factors: Using Leukine (sargramostim) in neonates and low birth weight infants
Leukine (sargramostim) injection solution contains a preservative called benzyl alcohol. This preservative can cause a serious side effect in newborn babies and children known as "gasping syndrome." This condition causes trouble breathing and can lead to death. To prevent benzyl alcohol exposure to your unborn baby during pregnancy or to children taking Leukine (sargramostim) , your provider will use the lyophilized powder form of the medication that's mixed with sterile water for injection instead.
Leukine (sargramostim) is usually given in a hospital or clinic setting by a healthcare provider. It's typically given as a slow infusion through the veins, but sometimes it's given as an injection under the skin. Your provider will determine the dose based on your body surface area (BSA), which takes into consideration your height and weight.
The typical dose of Leukine (sargramostim) is 250 mcg/m2 daily. When you'll start this medication, how you'll receive it, and the length of your treatment will depend on why you're taking Leukine (sargramostim) .
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Allergy to yeast-derived products or other granulocyte-macrophage colony-stimulating factor (GM-CSF) products
Growth or recovery of new blood cells after:
Chemotherapy to treat certain types of blood cancers (adults age 55 years and older)
Bone marrow transplant (adults and children ages 2 years and older)
To prepare the body for stem cell collection for stem cell transplant (adults only)
Raise the chance of survival after exposure to acute radiation (adults and children)
People getting bone marrow-suppressing chemotherapy
People with acute myeloid leukemia (AML) after induction or consolidation chemotherapy
People with cancer who received bone marrow transplants
People with severe, long-term neutropenia (low neutrophils)
Infection prevention in people with certain cancers receiving anticancer medications that can cause low white blood cells (or febrile neutropenia)
Increase survival in people exposed to bone marrow-suppressing radiation (Neulasta only)
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Centers for Disease Control and Prevention. (1982). Neonatal deaths associated with use of benzyl alcohol -- United States. Morbidity and Mortality Weekly Report.
Hong, I. (2016). Stimulatory versus suppressive effects of GM-CSF on tumor progression in multiple cancer types. Experimental & Molecular Medicine.
Lotfi, N., et al. (2019). Roles of GM-CSF in the pathogenesis of autoimmune diseases: An update. Frontiers in Immunology.
National Cancer Institute. (n.d.). Autologous stem cell transplant.
National Cancer Institute. (n.d.). Bone marrow transplant.
National Cancer Institute. (n.d.). Granulocyte-macrophage colony-stimulating factor.
National Center for Advancing Translational Sciences. (2023). Systemic capillary leak syndrome.
Partner Therapeutics, Inc. (2023). Leukine- sargramostim injection, powder, lyophilized, for solution [package insert]. DailyMed.
Sanofi-aventis U.S. LLC. (2018). Leukine® (sargramostim) for injection, for subcutaneous or intravenous use [package insert].
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