Leukine Disease Interactions

Transient supraventricular arrhythmia has been reported occasionally during sargramostim administration, particularly in patients with a history of cardiac arrhythmias. Therapy with sargramostim should be administered cautiously in patients with preexisting cardiac disease.

Sargramostim may cause fluid retention. Edema, capillary leak syndrome, and pleural and/or pericardial effusion have been reported. Therapy with sargramostim should be administered cautiously in patients with preexisting fluid retention or congestive heart failure. Fluid retention caused or worsened by sargramostim is often reversible following discontinuation of therapy or reduction in dosage, with or without diuretic administration.

In patients with preexisting hepatic impairment, the administration of sargramostim may induce elevations of bilirubin and liver enzymes, which are generally reversible following a dosage reduction or therapy interruption. Monitoring of hepatic function before treatment initiation, and at least every other week during therapy is recommended.

Sargramostim is a growth factor for hematopoietic progenitor cells. Therefore, it should not be used in patients with leukocytosis. During sargramostim treatment, if the absolute neutrophil count (ANC) exceeds 20,000 cells/mm3 or white blood cell count (WBC) exceeds 50,000 cells/mm3, therapy should be interrupted or the dosage reduced by half, depending on the clinical condition of the patient. Blood counts generally return to normal or baseline levels within 3 to 7 days of stopping therapy.

Sargramostim primarily stimulates the proliferation of normal myeloid precursor cells but may also, theoretically, enhance tumor growth, particularly in myeloid malignancies. Therapy with sargramostim should be administered cautiously in patients with myeloid tumors. Additionally, if sargramostim is used for PBPC (peripheral blood progenitor cell) collection in such patients, tumor cells may be released from the marrow and collected in the leukapheresis product. The effect of reinfusion of tumor cells is uncertain at this time.

The use of Leukine (brand of sargramostim) liquid or lyophilized powder reconstituted with Bacteriostatic Water for Injection is considered by the drug manufacturer to be contraindicated in neonates, particularly premature infants and infants of low birth weight. These preparations contain benzyl alcohol which, in bacteriostatic saline intravascular flush and endotracheal tube lavage solutions, has been associated with fatalities and severe respiratory and metabolic complications in low-birth-weight premature infants. However, many experts feel that, in the absence of benzyl alcohol- free equivalents, the amount of the preservative present in these formulations should not necessarily preclude their use if they are clearly indicated. The American Academy of Pediatrics considers benzyl alcohol in low doses (such as when used as a preservative in some medications) to be safe for newborns. Continuous infusions of high dosages of medications containing benzyl alcohol may, however, cause toxicity and should be avoided if possible.

In patients with preexisting renal impairment, the administration of sargramostim may induce elevations of serum creatinine, which are generally reversible following a dosage reduction or therapy interruption. Monitoring of renal function at least every other week during therapy is recommended.

Sargramostim may cause an influx of granulocytes in the pulmonary circulation. Dyspnea has been reported occasionally during or after treatment. Therapy with sargramostim should be administered cautiously in patients with lung disease or hypoxia. Respiratory status should be monitored during and immediately after therapy, and the infusion rate reduced by half if dyspnea occurs during IV administration. In patients who do not respond to the rate reduction or experience a worsening of symptoms, the infusion should be discontinued. For subsequent infusions, the standard rate schedule may be resumed (with careful monitoring), since respiratory symptoms often do not recur within the same treatment cycle.