The maximum amount of Leukine that can be safely administered in single or multiple doses has not been determined. Doses up to 100 mcg/kg/day (4,000 mcg/m2/day or 16 times the recommended dose) were administered to 4 patients in a Phase I uncontrolled clinical study by continuous IV infusion for 7 to 18 days. Increases in WBC up to 200,000 cells/mm3 were observed. Adverse events reported were dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache and chills. All these events were reversible after discontinuation of Leukine.

In case of overdosage, Leukine therapy should be discontinued and the patient carefully monitored for WBC increase and respiratory symptoms.

Leukine is contraindicated:

1) in patients with excessive leukemic myeloid blasts in the bone marrow or peripheral blood (3 10%).

2) in patients with known hypersensitivity to GM-CSF, yeast-derived products or any component of the product.

3) for concomitant use with chemotherapy and radiotherapy.

Due to the potential sensitivity of rapidly dividing hematopoietic progenitor cells, Leukine should not be administered simultaneously with cytotoxic chemotherapy or radiotherapy or within 24 hours preceding or following chemotherapy or radiotherapy. In one controlled study, patients with small cell lung cancer received Leukine and concurrent thoracic radiotherapy and chemotherapy or the identical radiotherapy and chemotherapy without Leukine. The patients randomized to Leukine had significantly higher incidence of adverse events, including higher mortality and a higher incidence of grade 3 and 4 infections and grade 3 and 4 thrombocytopenia.¹¹

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