Important Safety Considerations

Leukine® (sargramostim) is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥ 10%), in patients with known hypersensitivity to GM-CSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy.
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Minimize Risk of Infection

This information is intended to help you learn more about the risk of infection, which is a side effect of  chemotherapy and  radiation therapy.  The following content describe the signs and symptoms of infection as well as the steps you can take to avoid it.

Why am I at risk of infection?

Cancer treatments can temporarily weaken your immune system.  Chemotherapy and  radiation therapy,  which destroy cancerous cells, can also kill healthy  white blood cells (WBCs)  that fight infection. If your WBC count is low (a condition known as  neutropenia), your immune system is less able to protect you against infectious organisms.

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What is neutropenia?

Neutropenia is a condition in which the number of neutrophils in the blood is abnormally low.; neutrophils  are the most abundant type of WBCs and are the first to rush to the site of an infection and attack the "foreign invaders." Without sufficient numbers of neutrophils, your body may be unable to successfully defend itself against infection. Your absolute neutrophil count (ANC) refers to the number of neutrophils in your blood, which can indicate your risk of infection. An increased risk of infection occurs once neutrophils drop below 1000 cells per mm3 and especially below 500 cells per mm3. Following cancer therapy, your doctor will monitor the number of white blood cells (WBCs) in your blood with regular blood tests to determine when the WBCs reach a level that is high enough to help fight infections.

Your ANC is important, but it is only one laboratory measurement. Your medical team will determine your risk of infection by monitoring your ANC and the overall status of your health.

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How long will I be at risk of infection?

As long as your ANC remains lower than usual, your risk of infection remains higher than usual. The period of time it takes for WBCs to increase in number varies from person to person and depends on your treatment regimen.

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What kinds of infection should I know about?

If your immune system becomes weakened as a result of chemotherapy, you may be at risk for different types of infection, including bacterial, viral, or fungal. These infections can develop in your mouth, skin, lungs, urinary tract, colon, rectum, or reproductive system.

An important point to remember is that any infection, regardless of type, location, or significance, can disrupt your cancer treatment and, in severe cases, may require hospitalization.

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What are the signs and symptoms of infection?


You should be alert for: 

  • Chills or sweating
  • Sore throat, cough, and/or congestion
  • Inflammation (warmth or redness) of an area of your body
  • Diarrhea
  • Burning sensation during urination
  • Unusual discharge or itching from the penis or vagina

If you have one or more of these symptoms and suspect that you may be developing an infection, don't wait until the symptoms get worse. Contact your doctor or nurse right away. The sooner an infection is diagnosed and treated, the less chance that it may become severe (or, in some cases, life-threatening).

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How can I minimize the risk of infection?

There are several steps you can take to minimize your risk of infection while you are receiving cancer treatments.

AVOID:

  • Crowds, public places, and people who may be ill, including ill family members or visitors to your home
  • Changing diapers (human waste contains bacteria that can cause infections)
  • Gardening or lawn work without gloves (plants and soil contain bacteria; therefore, getting a cut or scratch can lead to infections)
  • Cleaning pets or litter boxes (animal waste contains bacteria that can cause infections)
  • Take-out and deli foods, raw or partially cooked foods, or unwashed fruits and vegetables. Foods that are partially cooked or have been sitting at room temperature can develop bacteria

DO:

  • Ask your medical team to advise you if your WBC count is low and you have an increased risk of infection
  • Request that your primary caregiver wear a surgical mask if he or she is ill and your WBC count is low
  • Keep intravenous (IV) access sites clean and dry
  • Carefully monitor any IV site and report any of the following symptoms to your medical team immediately: redness, tenderness, pain, swelling, drainage, or decrease in the flow rate
  • Follow all instructions to change dressings at ordered times, or if the dressings become wet or dirty
  • Immediately report to your medical team any known exposure to people with contagious diseases (eg, colds, flu, chickenpox) or anyone who has recently received a live vaccine (eg, oral polio vaccine)
  • Scrub your hands often and with extra care, especially before eating, after using the bathroom, and after touching pets
  • Clean your rectal area gently but thoroughly after bowel movements, from front to back
  • Take a warm bath or shower daily and pat your skin dry
  • Take extra care to protect your skin from becoming dry or sunburned
  • Prevent vitamin deficiencies by taking vitamins and supplements as directed by your doctor
  • Practice proper oral hygiene to prevent mouth sores, which can lead to oral infections
  • Trim nails carefully with clean clippers and/or scissors
  • Contact your medical team if you develop a fever

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Are there any treatments that can prevent infections?

Antibiotics are used to treat an infection once it occurs, and are sometimes given to prevent infections. In addition, there are other types of drugs available that can help your immune system recover from chemotherapy more quickly to reduce the chance of infections. Among those drugs is Leukine (sargramostim), which is frequently prescribed to raise ANCs.

Leukine is approved for use following induction chemotherapy in older adults with acute myelogenous leukemia, after bone marrow transplantation, before and/or after peripheral blood stem cell transplantation, and for bone marrow transplantation failure or engraftment delay.2

Clinical studies have shown that Leukine significantly reduced the incidence and severity of infections in older patients who received Leukine following induction chemotherapy for acute myelogenous leukemia.3,4


References:
  1. Bodey GP, Buckley M, Sathe YS, et al. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med. 1966;64:328-340.
  2. LEUKINE® (sargramostim) [package insert]. Genzyme Corporation 2009.
  3. Rowe JM, Andersen JW, Mazza JJ, et al. A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995;86:457-462.
  4. Rowe JM, Rubin A, Mazza JJ, et al. Incidence of infections in adult patients (> 55 years) with acute myeloid leukemia treated with yeast-derived GM-CSF (sargramostim): results of a double-blind prospective study by the Eastern Cooperative Oncology Group. In: Hiddeman et al, eds. Acute Leukemias V: Experimental Approaches and Management of Refractory Diseases. Berlin, Germany: Springer-Verlag; 1996.

Leukine Resources

Indication

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)

  • You should not use Leukine if you have high levels of abnormal white blood cells, called leukemic blasts, in the bone marrow or blood. You should not use Leukine® if you have had an allergic reaction to GM-CSF, other products made from yeast, or any ingredient used to make Leukine. If you are also receiving chemotherapy or radiation therapy, do not take your Leukine in the period 24 hours before through 24 hours after the administration of your chemotherapy or radiation therapy.
  • A generalized allergy is an uncommon but potentially serious reaction to Leukine. This may include askin rash over your entire body, hives, trouble breathing, a fast pulse, sweating, and feeling faint. In severe cases a generalized allergy may be life-threatening. If you think you are having a generalized allergy to Leukine, stop taking Leukine and notify your doctor immediately.
  • Liquid solutions containing benzyl alcohol, including Leukine liquid or lyophilized Leukine reconstituted with Bacteriostatic Water For Injection, USP should not be administered to newborns.
  • Leukine should be used with caution, and your doctor should monitor you if you have preexisting fluid buildup, heart or lung conditions, or kidney or liver disease.
  • Some patients taking Leukine may experience unwanted side effects, most of which are mild to moderate and not serious. Some of the more common side effects include bone pain, feeling like you have the flu, feeling tired or weak, muscle aches, diarrhea, stomach upset, weight loss, or loss of appetite. You may also get a low-grade fever (less than 100.5°F or 38°C) about 1 to 4 hours after an injection, or you may have swelling, redness, and/or discomfort where Leukine was injected.
  • Some side effects or symptoms may be serious. These include developing a high fever (over 100.5°F or 38°C), signs of infection including chills, sore throat, or congestion (such as stuffy nose), having trouble breathing, wheezing, or fainting, or developing extensive skin rash, hives, or other signs of an allergic reaction, experiencing sudden weight gain or other signs of fluid buildup, such as swollen legs or feet, having chest pain, chest discomfort, or a rapid or irregular pulse. These may be due to Leukine, your illness, or other treatments that you may have received. Many of these side effects can be reduced or eliminated. These or other side effects you may be concerned about should be reported promptly to your doctor, nurse, or pharmacist.
  • Your doctor will monitor your white blood cell and platelet counts with blood tests during Leukine treatment. If your white blood cell or platelet counts rise above certain levels, your doctor may stop your Leukine treatment, or may reduce the dose. If your doctor detects progression of your disease, he/she may stop your Leukine therapy.
  • Drugs that can increase WBCs, such as lithium and corticosteroids, should be used with caution while receiving Leukine Interactions between Leukine and other drugs have not been fully evaluated.

Please see full Prescribing Information.