Drug Notebook

FDA Alerts

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 The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the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.

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sargramostim
(sar grah MOSS tim)

What is sargramostim?
Sargramostim is a protein that stimulates the production of white blood cells. Sargramostim is similar a substance in the body called granulocyte-macrophage colony stimulating factor (GM-CSF). Sargramostim is used to increase white blood cells and decrease the risk of infection in conditions such as cancer, bone marrow transplant, and pre-chemotherapy blood cell collection. Sargramostim may also be used for purposes other than those listed in this medication guide.

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What are the possible side effects of sargramostim?

If you experience any of the following serious side effects, stop using sargramostim and seek emergency medical treatment or contact your doctor immediately:

  • 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:

  • bone pain;

  • "flu-like" feeling;

  • chills;

  • muscle aching or weakness;

  • tiredness;

  • headache;

  • diarrhea;

  • 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.

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How should I use sargramostim?
Use sargramostim exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you. Sargramostim can be used subcutaneously (SC) or intravenously (IV). Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject the medication. Do not administer an injection if you are unsure how it should be injected, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you.

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What is the most important information I should know about sargramostim?
Do not administer an injection if you are unsure how it should be injected, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you. Contact your doctor if you develop a fever, chills, sore throat, congestion, or other signs of infection or illness while using sargramostim.

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What happens if I miss a dose?
Contact your doctor if you miss a dose of this medication by more than a few hours.

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What other drugs will affect sargramostim?
Before using this medication, tell your doctor if you are taking lithium (Eskalith, Lithobid, Lithane, others); 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.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Sargramostim has been assigned to FDA pregnancy category C by the FDA. Animal reproduction studies have not been conducted. There are no controlled data in human pregnancy. Sargramostim is only recommended for use during pregnancy when benefit outweighs risk.

There are no data on the excretion of sargramostim into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Endogenous GM-CSF has been detected in human milk; however, no effect on neutrophil chemotaxis in the infant was shown. Whether recombinant GM-CSF (sargramostim) is present in human milk, and its clinical effects, are not presently known.

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Who should NOT use this medication?

  • Excessive (i.e., ≥10%) leukemic myeloid blasts in the bone marrow or peripheral blood.
  • Known hypersensitivity to sargramostim, any ingredient in the formulation, or yeast-derived products.
  • Concomitant use of chemotherapy or radiation therapy.

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What does my medication look like?
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.

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What happens if I overdose?
Seek emergency medical attention if an overdose is suspected. 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.

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What should I discuss with my healthcare provider before using sargramostim?
Do not use sargramostim without first talking to your doctor if you have an allergy to yeast. You may have an allergic reaction to this medication. Before using sargramostim, tell your doctor if you are undergoing radiation or chemotherapy; have asthma or another lung disease; have heart disease, especially an irregular heartbeat or congestive heart failure; have fluid retention; have myeloid (bone marrow) cancer; have kidney disease; or have liver disease. You may not be able to use sargramostim or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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