Bleeding is the most frequent adverse event in clinical trials.1 For a complete list of adverse events, click here.
	In clinical trials, the incidence of major bleeding with REFLUDAN was not statistically different from the historical control group2

Efficacy and safety you can rely on from the first direct thrombin inhibitor approved for HIT.

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.

Adverse Events in Drug Monitoring Program    Adverse event       Incidence (n=496)       Minor bleeding       5.2%       Major bleeding       5.4%       Fever       1.2%       Allergic reaction       0.8%       Other       1.0%

	Small effect on INR when REFLUDAN is stopped 4
	No complicated dosing calculations required during conversion1
	As with transition from heparin to coumarin, allow several days for coumarin to reach necessary therapeutic levels before discontinuing REFLUDAN5

Please consult full Prescribing Information for a complete list, including the incidence, of adverse events.

A Proven Safety Profile Adverse Events Reported in Clinical Trials in HIT Patients