The maximum amount of Kepivance® that can be safely administered in a single dose has not been determined. Single doses of 250 mcg/kg have been administered intravenously to 8 healthy volunteers without severe or serious adverse effects. Five of 14 patients receiving six doses of 80 mcg/kg/day administered intravenously over two weeks (three doses preceding and three doses following myeloablative chemotherapy/TBI) experienced serious or severe adverse events. These events were consistent with those observed at the recommended dose but were generally more severe.

Kepivance® is contraindicated in patients with known hypersensitivity to E coli-derived proteins, palif ermin, or any other component of the product.

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