Important Safety Considerations

Leukine® (sargramostim) 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.
Click here for additional Important Safety Information.
Click here for Indications.

Adverse Events

Leukine^® Adverse Event Profile Similar to Placebo

The following side effects for Leukine^® (sargramostim) were observed in clinical trials.

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%

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^{*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

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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

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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.

References:

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

Leukine Resources

Treatment with Leukine

Indication

Leukine^® (sargramostim) 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 Information for Leukine^® (sargramostim)

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, orany 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.
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.

Adverse Events

Leukine® Adverse Event Profile Similar to Placebo

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

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

Leukine Resources

Treatment with Leukine

Indication

Important Safety Information for Leukine® (sargramostim)

Leukine^® Adverse Event Profile Similar to Placebo

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

^{*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 events occurring in >50% of AlloBMT patients taking Leukine¹

Important Safety Information for Leukine^® (sargramostim)