Benefits and Risks
In addition to neutrophil recovery, Leukine® (sargramostim):
- Is indicated for use following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrafill recovery and to reduce the incidence of sever life threatening infection and infections resulting in death.
- Adverse events occurring in >10% of AML patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, and anorexia.
- Improve key clinical endpoints in multiple transplantation settings
- Prolonged survival in patients experiencing bone marrow transplant engraftment delay or failure11
- Reduces the incidence of severe (grade 3/4) mucositis and infection following allogeneic bone marrow transplantation (BMT)1,5
- Reduces the duration of hospitalization and antibiotic therapy and the rate of infection following autologous BMT11,6
- Shortens time to myeloid engraftment of peripheral blood progenitor cell transplantation1
- Adverse events occurring in >10% of Autologous BMT patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
- Adverse events occurring in >10% of Allogeneic BMT patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo 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).
- LEUKINE® (sargramostim) [package insert]. Genzyme Corporation 2009.
- Data on file. Genzyme Corporation.
- 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: Hiddemann W, et al, eds. Acute Leukemias V: Experimental Approaches and Management of Refractory Diseases. Berlin, Germany: Springer-Verlag; 1996:178-184.
- Rowe JM. Treatment of acute myeloid leukemia with cytokines: effect on duration of neutropenia and response to infections. Clin Infect Dis. 1998;26:1290-1294.
- Nemunaitis J, Rosenfeld CS, Ash R, et al. Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation. Bone Marrow Transplant. 1995;15:949-54.
- Nemunaitis J, Rabinowe SN, Singer JW, et al. Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. N Engl J Med. 1991;324:1773-1778.