Refludan Overdose, Contraindications and Information - Lepirudin

Refludan Overdose, Contraindications and Information - Lepirudin

OVERDOSE

No specific antidote for REFLUDAN is available. If life-threatening bleeding occurs and excessive plasma levels of lepirudin are suspected, the following steps should be followed:

• Immediately STOP REFLUDAN administration I

• Determine aPTT and other coagulation levels as appropriate

• Determine hemoglobin and prepare for blood transfusion

• Follow the current guidelines for treating patients with shock

Individual clinical case reports and in vitro data suggest that either hemofiltration or hemodialysis (using high-flux dialysis membranes with a cutoff point of 50,000daltons, eg, AN/69) may be useful in this situation.

In studies in pigs, the application of von Willebrand Factor (vWF, 66IU/kg body weight) markedly reduced the bleeding time. The clinical significance of this data is unknown.

REFLUDAN is contraindicated in patients with known hypersensitivity to hirudins or to any of the components in REFLUDAN [lepirudin (rDNA) for injection].