PRAXBIND infusion resulted in decrease of blood dabigatran to unmeasurable levels by the time infusion of both 2.5 gram doses was completed.Doses between 1 gram and 4 grams were less effective. PRAXBIND infusion of 5 grams in two divided 2.5 gram doses 15 minutes apart resulted in immediate and complete reversal of anticoagulation that was sustained for at least 24 hours.Randomized, double-blind, placebo-controlled trials in 283 healthy volunteers explored the safety, effectiveness, dosing, duration of reversal, anti-drug antibodies, and any differences in between women and men, between younger and older subjects, and between subjects with normal or impaired kidney function. PRAXBIND is specific for Pradaxa it does not reverse the action of other anticoagulants. It is the first reversal agent for a new class of oral anticoagulants that inhibit the clotting process but require no monitoring with blood tests. PRAXBIND is a humanized monoclonal antibody fragment designed to bind to dabigatran and reverse its action as an anticoagulant. What are the benefits of this drug (results of trials used to assess efficacy)? In an ongoing clinical trial of PRAXBIND, the blood-thinning effect of Pradaxa was fully reversed in 89 percent of patients within four hours of receiving PRAXBIND. PRAXBIND is given by intravenous injection. PRAXBIND is a drug to be used during emergency or life-threatening situations when there is a need to reverse the blood-thinning effects of Pradaxa, an anticoagulant, commonly called a “blood thinner”. Refer to the PRAXBIND Prescribing Information for complete information.ĭRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? Always speak to your health provider about the risks and benefits of a drug. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.ĭo not rely on Snapshots to make decisions regarding medical care. The “MORE INFO” bar shows more detailed, technical content for each section. The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups.
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