The cost of Praxbind intravenous solution (2.5 g/50 mL) is approximately $3,662 for a supply of 100 mL. The recommended dose of Praxbind contains 4 g of sorbitol, and the minimum amount of sorbitol that can trigger a serious reaction is not known.Īdverse Reactions: The most frequently reported adverse reactions (≥5 percent) in patients treated with Praxbind were hypokalemia, delirium, constipation, pyrexia, and pneumonia. Risks of serious adverse reactions in patients with hereditary fructose intolerance due to sorbitol excipient: When prescribing Praxbind to patients with hereditary fructose intolerance, the combined daily metabolic load of sorbitol/fructose from all sources, including other drugs containing sorbitol, must be considered. Re-elevation of coagulation parameters: In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or those requiring a second emergency surgery/urgent procedure, an additional 5 g dose of Praxbind may be considered. Resume anticoagulant therapy as soon as medically appropriate. Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thromboembolic risk of their underlying disease. The Institute for Safe Medication Practices (ISMP) has alerted health care professionals about the risks of confusing idarucizumab with the antineoplastic drug idarubicin. The recommended dose of Praxbind is 5 g, provided as two separate vials each containing 2.5 g/50 mL of idarucizumab. This medication is for intravenous use only. Praxbind is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with dabigatran etexilate (Pradaxa) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in the case of life-threatening or uncontrolled bleeding.

The FDA granted accelerated approval to Praxbind in October 2015 and provided full approval April 17, 2018.

Idarucizumab (Praxbind) is the first and only specific reversal agent for a novel oral anticoagulant (NOAC) approved by the US Food and Drug Administration (FDA).

New Developments in Direct Oral Anticoagulant Safety and IndicationsĮxplore This Issue ACEP Now: Vol 38 – No 01 – January 2019.Results Confirm Idarucizumab’s Ability to Restore Clotting in Dabigatran Recipients.A Case Example: Reversing Anticoagulant Dabigatran with Idarucizumab.

Praxbind fda approval