Leukine® (sargramostim)
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For more information, please consult the full Prescribing Information (PDF). To see the product site go to www.leukine.com |
Indication:
Leukine is indicated for use following induction chemotherapy in older adult patients 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.
For additional indications please see full prescribing information.
Leukine is a recombinant human granulocyte macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells. Leukine is a glycoprotein of 127 amino acids characterized by three primary molecular species having molecular masses of 19,500, 16,800 and 15,500 daltons. The amino acid sequence of LEUKINE differs from the natural human GM-CSF by a substitution of leucine at position 23, and the carbohydrate moiety may be different from the native protein. Sargramostim has been selected as the proper name for yeast derived rhu GM-CSF.
WARNINGS:
Pediatric Use Benzyl alcohol is a constituent of liquid Leukine and Bacteriostatic Water for Injection diluent. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants. Fluid Retention Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after Leukine administration. Sequestration of granulocytes in the pulmonary circulation has been documented following Leukine infusion and dyspnea has been reported occasionally in patients treated with Leukine. Occasional transient supraventricular arrhythmia has been reported in uncontrolled studies during Leukine administration, particularly in patients with a previous history of cardiac arrhythmia. In some patients with preexisting renal or hepatic dysfunction enrolled in uncontrolled clinical trials, administration of Leukine has induced elevation of serum creatinine or bilirubin and hepatic enzymes.
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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For more information, please consult the full Prescribing Information (PDF).
To see the product site go to www.leukine.com.