Indications and Usage

LEUKINE^® (sargramostim) is indicated for use following induction chemotherapy in older adults with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death.

Drug Interactions

Drugs that can increase white blood cells (WBCs), such as lithium and corticosteroids, should be used with caution while receiving LEUKINE. Also, LEUKINE should not be used 24 hours before through 24 hours after any chemotherapy or radiation therapy. Interactions between LEUKINE and other drugs have not been fully evaluated.

Important Safety Considerations

Leukine is contraindicated in patients with excessive leukemic 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 or anaphylactic reactions occur, Leukine therapy should immediately be discontinued and appropriate therapy initiated.

Liquid solutions containing benzyl alcohol (including liquid LEUKINE) or lyophilized LEUKINE reconstituted with Bacteriostatic Water for Injection, USA (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 CHF; respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.

Edema, capillary leak syndrome, pleural and or/pericardial effusion, supraventricular tachycardia, sequestration of granulocytes in the pulmonary circulation and dyspnea have been reported in patients after 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.

Nearly all patients reported leukopenia, thrombocytopenia, and anemia. 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.

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.

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For important risk and use information, please see the full prescribing information.