Important Safety Considerations

Do not administer LEUKINE to patients with a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product. Anaphylactic reactions have been reported with LEUKINE.
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This information is intended for US Healthcare Professionals only.

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Leukine® (sargramostim) is used to help increase the number and function of white blood cells after bone marrow transplantation, in cases of bone marrow transplantation failure or engraftment delay, before and after peripheral blood stem cell transplantation, and following induction chemotherapy in older patients with acute myelogenous leukemia. Your doctor may also choose to treat other conditions with Leukine.

Important Safety Information for Leukine® (sargramostim)

Do not take LEUKINE if you have had a serious allergic reaction to human GM-CSF, such as sargramostim, products that are made from yeast, or any of the ingredients in LEUKINE. See the full Prescribing Information for a complete list of ingredients in LEUKINE.

What are possible side effects of LEUKINE?

LEUKINE may cause serious side effects, including:

  • Serious allergic reactions. LEUKINE can cause serious allergic reactions that can be severe. Get medical help right away if you get any of the following signs or symptoms of a serious allergic reaction with LEUKINE, including: skin rash over your entire body, hives, trouble breathing, wheezing, swelling around your mouth or eyes, a fast heartbeat, sweating, and dizziness or feeling faint.
  • Infusion related reactions. When LEUKINE is given as an infusion, it can cause reactions during or soon after an infusion. Tell your healthcare provider or nurse right away if you develop trouble breathing, skin flushing, a fast pulse, dizziness or you feel faint during or soon after your infusion.
  • Too much body fluid (fluid retention) and Capillary Leak Syndrome. LEUKINE can cause you to have too much fluid in your body, and fluid may leak from blood vessels into your body’s tissues. This can happen anywhere in your body, including around your heart and lungs. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
  • swelling or puffiness of your feet or ankles, and are urinating less than usual
  • swelling of your stomach area (abdomen) and feeling of fullness
  • sudden weight gain
  • swollen legs or feet
  • trouble breathing
  • dizziness or feeling faint
  • a general feeling of tiredness
  • Abnormal heart rhythm. An abnormal heart rhythm has happened during treatment with LEUKINE, especially in people with a history of an abnormal heart rhythm.
  • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with LEUKINE.
  • Risks of using LEUKINE injection in newborns, babies born with a low birth weight, and in pregnant women. LEUKINE injection contains the preservative benzyl alcohol. Medicines that contain benzyl alcohol, including LEUKINE, can cause serious side effects, that can lead to death in newborns and babies born with a low birth weight. Avoid using LEUKINE injection in newborns, babies born with a low birth weight, and in pregnant women.

The most common side effects of LEUKINE in people who receive an autologous bone marrow transplant include: fever, nausea, diarrhea, vomiting, pain throughout the lining of the digestive tract, lack of energy, generally do not feel well, decreased appetite, rash, stomach and intestinal problems, fluid buildup, and weakness.

The most common side effects of LEUKINE in people who receive an allogeneic bone marrow transplant include: diarrhea, fever, nausea, rash, vomiting, mouth sores, decreased appetite, stomach-area (abdomen) pain, headache and high blood pressure.

The most common side effects of LEUKINE in people with AML include: fever, liver injury, skin reactions, infections, abnormalities of the salts and other components in the blood, nausea, diarrhea, abnormalities of the reproductive and urinary systems, lung injury, vomiting, neurologic changes, mouth sores and weight loss.

These are not all the possible side effects of LEUKINE.

Call your healthcare provider for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information.