for: Reversal Agent for Pradaxa
Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated as a specific reversal agent for the anticoagulant effect of dabigatran (Pradaxa). These highlights do not include all the information needed to use PRAXBIND safely and effectively. See full prescribing information for PRAXBIND.
PRAXBIND® (idarucizumab) injection, for intravenous use
Initial U.S. Approval: 2015
RECENT MAJOR CHANGES
Dosage and Administration, Preparation (2.2) 4/2018
INDICATIONS AND USAGE
PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:
For emergency surgery/urgent procedures
In life-threatening or uncontrolled bleeding (1)
DOSAGE AND ADMINISTRATION
For intravenous use only.
The recommended dose of PRAXBIND is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab. (2.1)
There is limited data to support administration of an additional 5 g of PRAXBIND. (2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 2.5 g/50 mL solution in a single-dose vial (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate. (2.4, 5.1)
Re-elevation of Coagulation Parameters: In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or requiring a second emergency surgery/urgent procedure, an additional 5 g dose of PRAXBIND may be considered. (5.2)
Hypersensitivity reactions: Discontinue administration and evaluate. (5.3)
Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient: Patients with hereditary fructose intolerance may be at risk of adverse reactions. (5.4)
ADVERSE REACTIONS
In healthy volunteers, the most frequently reported adverse reactions in ≥5% of subjects treated with idarucizumab was headache. (6.1)
In patients, the most frequently reported adverse reactions in ≥5% of patients treated with idarucizumab were constipation and nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2018
