ADVERSE REACTIONS:

Adverse Reactions in Healthy Volunteers

Comparable rate of adverse events in volunteers who received PRAXBIND vs placebo

  • Three clinical studies in healthy volunteers have been completed in which 224 subjects were treated with PRAXBIND. The overall frequency of adverse events in those taking PRAXBIND (25%) and placebo (25%) was similar
    • The most frequent adverse event reported was headache at 5%
    • When re-administered to 6 healthy subjects, no differences in safety or indications of allergic reactions were revealed*

Adverse Reactions in the RE-VERSE AD™ Trial

  • 123 patients who a) experienced life-threatening or uncontrolled bleeding, or b) required emergency surgery or an urgent procedure were treated with PRAXBIND
    • Adverse reactions reported in ≥5% of patients were: hypokalemia (7%), delirium (7%), constipation (7%), pyrexia (6%), and pneumonia (6%)
  • Fatalities reported could be attributed either as a complication of the index event or associated with co‑morbidities
    • Of the 26 reported, 11 were within the first day after dosing

No Prothrombotic Effect Identified in Patients

  • All 5 patients reporting thrombotic events in RE-VERSE AD™ were not taking antithrombotic therapy at the time of the event, and the events could be attributed to the underlying medical condition of the patient
    • 1 report was 2 days after PRAXBIND administration
    • 4 reports were 7 or more days after PRAXBIND administration

Patients being treated with PRADAXA therapy have underlying disease states that predispose them to thromboembolic events. Reversing PRADAXA therapy exposes patients to the thrombotic risk of their underlying disease. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.

PRADAXA treatment can be re-initiated 24 hours after administration of PRAXBIND.

There are serious risks and adverse reactions to consider when treating patients with PRAXBIND, including warnings and precautions for thromboembolic risk, re-elevation of coagulation parameters, hypersensitivity reactions and risks of serious adverse reactions in patients with hereditary fructose intolerance due to sorbitol excipient. Please see more complete details of these risks in the Important Safety Information below and the adverse reactions page.

RE-VERSE AD™= A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran.

*As shown in 6 healthy subjects aged 45-64 years re-administered with 2.5 g PRAXBIND 2 months after first infusion.