Important Safety Considerations
Leukine® 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. View additional Important Safety Information. View Indications.

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 Some doctors may choose to prescribe Leukine for other uses as well.

Patients who take Leukine experience fewer and less severe infections. For example, 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

Indication

Leukine® is indicated for the following uses: (i) following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery; (ii) for mobilization and following transplantation of autologous peripheral blood progenitor cells; (iii) for myeloid reconstitution after autologous or allogeneic bone marrow transplantation (BMT); (iv) for use in bone marrow transplantation failure or engraftment delay.

Important Safety Considerations

  • Leukine 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.
  • Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious allergic or anaphylactic reactions occur, Leukine therapy should be immediately discontinued and appropriate therapy initiated.
  • Liquid solutions containing benzyl alcohol (including liquid Leukine) or lyophilized Leukine reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates.
  • Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure, respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.
  • Edema, capillary leak syndrome, pleural and/or pericardial effusion, sequestration of granulocytes in the pulmonary circulation, and dyspnea have been reported in patients after Leukine administration. Occasional transient supraventricular arrhythmia has been reported during Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration.
  • Adverse events occurring in >10% of patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: in AML patients – (fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, anorexia); in Autologous BMT patients – (asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder); and in Allogeneic BMT patients – (abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high BUN, and high cholesterol).
  • If ANC > 20,000 cells/mm3 or if platelet counts > 500,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
  • Leukine therapy should be discontinued if disease progression is detected during treatment.

Please see full Prescribing Information.

To report suspected adverse events, contact Genzyme Corporation at 1-888-4RX-LEUKINE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.