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This section outlines critical safety information and warnings associated with the use of Leukine (sargramostim). It is important to read these carefully and discuss any concerns with your healthcare provider.

• Allergic and Infusion-related Reactions: Leukine (sargramostim) may trigger infusion reactions after the first dose in each treatment cycle. Symptoms can include breathing difficulties, flushing, low blood pressure, fainting, or a rapid heartbeat. Healthcare professionals will monitor for these signs and may adjust the infusion rate if symptoms arise. Such reactions typically do not recur after the first dose of each cycle.

• Capillary Leak Syndrome (CLS) and Swelling: Although rare, Leukine (sargramostim) can lead to CLS or swelling. Your healthcare provider will monitor your weight during treatment. Contact your provider if you experience dizziness, lightheadedness, unexplained swelling, or weight gain. Your provider may pause or adjust your dose or prescribe a diuretic to manage swelling. This is particularly important for individuals with a history of fluid retention or heart failure.

• Changes in Heartbeat: Leukine (sargramostim) has been associated with changes in heartbeat, especially in individuals with a history of irregular heartbeats. These changes generally resolve once the medication is discontinued.

• Cancer Risk: As a growth factor, Leukine (sargramostim) may promote the growth of other tumors, particularly those of myeloid cell lines. Your healthcare provider will conduct regular laboratory tests and may discontinue the medication if the risks outweigh the benefits.

• Gasping Syndrome in Infants: The injection solution form of Leukine (sargramostim) contains benzyl alcohol, which can cause a severe condition known as "gasping syndrome" in infants, potentially leading to respiratory distress and death. To avoid benzyl alcohol exposure in pregnant women and children, the lyophilized powder form mixed with sterile water will be used.

• Contraindications: Leukine (sargramostim) should not be used by individuals allergic to yeast-derived products or other granulocyte-macrophage colony-stimulating factor (GM-CSF) products. If you have these allergies, consult with your healthcare provider before starting this medication.

When taking this medication, you may experience some mild side effects such as fever, nausea, diarrhea, vomiting, or blisters in sensitive skin areas. Hair loss, weakness, and a reduced appetite may also occur, but these are generally manageable. Additionally, you might notice redness, swelling, itching, or bruising at the injection site, which should be monitored if they persist.

More uncommon side effects include mouth sores, trouble breathing, or urinary tract infections. While these are less frequent, it is important to speak with your healthcare provider if they occur. Some individuals may also experience rash and swelling, which should be reported to your doctor, especially if they are bothersome.

Rare but serious side effects that require immediate medical attention include infusion-related reactions such as trouble breathing, dizziness, or a fast heartbeat. Serious allergic reactions, indicated by rash, swelling around the mouth or eyes, or wheezing, also necessitate urgent care. Additionally, symptoms like sudden weight gain, ankle swelling, or abnormal heart rhythms are critical and should prompt immediate consultation with a healthcare professional.

While these side effects can be concerning, remember that many people use this medication without experiencing serious issues. Nonetheless, it's crucial to remain vigilant and communicate with your healthcare provider about any side effects you encounter to ensure safe and effective treatment.