Indications: Praxbind (idarucizumab) injection is a humanized monoclonal antibody fragment indicated in patients treated with Pradaxa (dabigatran) when reversal of the anticoagulant effects of dabigatran is needed:

• For emergency surgery/urgent procedures.

• In life-threatening or uncontrolled bleeding.

Dosing: The recommended dose (injection) of Praxbind is 5 g, provided as 2 separate, single-use vials each containing 2.5 g/50 mL idarucizumab.

Warnings/Precautions: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate.

Side Effects/Risks: The most frequently reported adverse reaction in ≥5% of subjects treated with idarucizumab was headache. In patients, the most frequently reported adverse reactions in ≥5% of patients treated with idarucizumab were hypokalemia, delirium, constipation, pyrexia, and pneumonia.

Source: Highlights of Prescribing Information: Praxbind (idarucizumab). FDA website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761025lbl.pdf. Revised October 2015. Accessed October 20, 2015.