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.

Adverse Events

Leukine® Adverse Event Profile Similar to Placebo

The following side effects for Leukine® (sargramostim) were observed in clinical trials. These side effects were usually mild to moderate and manageable.1

  • In 3 prospective, randomized, double-blind, placebo-controlled trials, only 1 adverse event was significantly increased in patients receiving Leukine® (n=170) vs placebo (n=166)1
    • In the pivotal AML trial, skin-associated events were observed in 77% (40/52) of patients taking Leukine vs 45% (21/47) of patients taking placebo (P=.002) 
  • No adverse effect on disease outcomes or relapse rates1

Adverse events occurring in >50% of AML patients taking Leukine1

Adverse Event Placebo
(n=47)		 LEUKINE
(n=52)
Fever (no infection) 74% 81%
Liver-associated events 83% 77%
Skin-associated events 45% 77%
Infection 68% 65%
Nausea 55% 58%
Metabolic-associated events 49% 58%
Diarrhea 53% 52%

 *Results of the pivotal study of Leukine involving patients aged 55 to 70 years with de novo AML.

Adverse events occurring in >50% of AuBMT patients taking Leukine1

Adverse Event Placebo
(n=77)		 LEUKINE
(n=79)
Fever
 96 95
Nausea 96 90
Diarrhea 82 89
Vomiting 90 85
Mucous membrane disorder
 78 75
Alopecia 74 73
Asthenia 51 66
Malaise 51 57
Anorexia 58 54


Adverse events occurring in >50% of AlloBMT patients taking Leukine1

Adverse Event Placebo
(n=56)		 LEUKINE
(n=53)
Diarrhea
 66 81
Fever 80 77
Nausea 66 70
Vomiting 57 70
Rash
 73 70
Stomatitis 63 62
Anorexia 57 51

Other adverse events have been reported; Read the full Prescribing Information for more information.

  • In clinical trials, there were occasional reports of fluid retention, dyspnea, supraventricular tachycardia, and laboratory abnormalities (increases in creatinine, bilirubin, and liver enzymes)1
  • Transient low-grade elevations in temperature (<38°C/100.5°F) may occur and can be managed effectively with analgesics and antipyretics such as acetaminophen2
    • In clinical trials of Leukine, fever occurred at rates similar to placebo1
  • Bone pain generally occurs in the areas of large marrow reserves, such as the sternum, pelvis, or long bones, and may be a result of expansion of the myeloid cell mass2
  • Occasionally, a skin reaction may occur at the injection site. This may be managed and/or prevented through proper injection technique (refer to Patient Information sheet)2,3

Refer to Patient Prescribing Information on the Patient & Caregivers section. 

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. LEUKINE® (sargramostim) [package insert]. Genzyme Corporation 2009.

  2. Buchsel PC, Forgey A, Grape FB, Hamann SS. Granulocyte macrophage colony-stimulating factor: current practice and novel approaches. Clin J Onc Nurs. 2002;6:198-205.

  3. Data on file. Genzyme Corporation.