"The U.S. Food and Drug Administration today expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one.
This first-of-its-kind use is"...
In case of overdose (eg, suggested by excessively high aPTT values) the risk of bleeding is increased.
No specific antidote for REFLUDAN (lepirudin) is available. If life-threatening bleeding occurs and excessive plasma levels of lep-irudin are suspected, the following steps should be followed:
- Immediately STOP REFLUDAN (lepirudin) administration
- 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 50,000 daltons, eg, AN/69) may be useful in this situation.
In studies in pigs, the application of von Willebrand Factor (vWF, 66 IU/kg body weight) markedly reduced the bleeding time. The clinical significance of this data is unknown.
REFLUDAN (lepirudin) is contraindicated in patients with known hypersensitivity to hirudins or to any of the components in REFLUDAN [lepirudin (rDNA) for injection].
Last reviewed on RxList: 7/31/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Refludan Information
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