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REFLUDAN is indicated for anticoagulation in patients with heparin-induced thrombocytopenia (HIT) and associated thromboembolic disease in order to prevent further thromboembolic complications.
REFLUDAN is contraindicated in patients with a known hypersensitivity to hirudins or to any of the components in REFLUDAN.
The most common adverse events in clinical trials were bleeding, such as from puncture sites and wounds (14%), anemia (13%), and hematoma (11%).
As with other anticoagulants, hemorrhage can occur at any site in patients receiving REFLUDAN. There have been reports of intracranial bleeding with REFLUDAN in the absence of concomitant thrombolytic therapy.
Serious anaphylactic reactions that have resulted in shock or death have been reported during initial administration or upon second or subsequent re-exposure.
In hemodialysis patients or in case of acute renal failure (creatinine clearance below 15 mL/min or serum creatinine above 6.0 mg/dL), infusion of REFLUDAN is to be avoided or stopped.
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![REFLUDAN [lepirudin (rDNA) for injection]: the first direct thrombin inhibitor FDA-approved for heparin induced thrombocytopenia (HIT)](../images/common/logo.gif){kind=logo}
