Special Alerts:
[Posted 01/24/2008; Selected revisions 6/25/08] Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of sargramostim (Leukine), a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine.
Bayer has since reformulated liquid Leukine and this EDTA-free Leukine preparation is now available through normal distribution channels. Healthcare professionals should immediately stop using liquid Leukine preparations containing EDTA and return unused vials to the manufacturer. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Leukine and http://www.fda.gov/medwatch/safety/2008/Leukine_DHCP_01-23-2008.pdf and the manufacturer’s website at: http://www.leukine.com.
Contact your doctor if you miss a dose of this medication by more than a few hours.
Symptoms of a sargramostim overdose include shortness of breath, a feeling of discomfort or illness (malaise), nausea, fever, a rash, a fast heartbeat, headache, and chills.
There are no restrictions regarding foods, beverages, or activities during treatment with sargramostim unless your doctor directs otherwise.
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
dizziness or fainting;
a fever (over 100.5 degrees Fahrenheit or 38 degrees Celsius);
signs of infection including chills, sore throat, or congestion or redness, pain, or swelling around a wound or sore;
swelling of the feet or lower legs;
sudden weight gain (5 pounds or more); or
chest pain, chest discomfort, or a fast, irregular pulse.
Other, less serious side effects may be more likely to occur. Continue to use sargramostim and talk to your doctor if you experience:
"flu-like" feeling;
chills;
muscle aching or weakness;
tiredness;
headache;
nausea, upset stomach, or loss of appetite;
rash; or
swelling, redness, or pain at the injection site.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Before using this medication, tell your doctor if you
are taking a steroid such as prednisone (Deltasone, others), methylprednisolone (Medrol, others), prednisolone (Prelone, others), dexamethasone (Decadron, others), and others; or
are undergoing radiation or chemotherapy.
You may not be able to use sargramostim or you may require special monitoring if you are taking any of the medications listed above.
Drugs other than those listed here may also interact with sargramostim. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
Your pharmacist has additional information about sargramostim written for health professionals that you may read.
Sargramostim is available with a prescription under the brand name Leukine. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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