Idarucizumab

PRAXBIND is 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 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

Idarucizumab is a specific reversal agent for dabigatran. It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin, neutralizing their anticoagulant effect.

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. There is limited data to support administration of an additional 5 g of PRAXBIND.

None. None

Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate. 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. Hypersensitivity reactions: Discontinue administration and evaluate. 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.

The following serious adverse reactions are described in more detail elsewhere in the labeling: Thromboembolic Risk Hypersensitivity Reactions Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient In healthy volunteers, the most frequently reported adverse reactions 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 constipation and nausea.

Store PRAXBIND vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. PRAXBIND vials may be stored at room temperature, 25°C (77°F), for up to 48 hours in the original carton to protect from light. PRAXBIND vials may be stored at room temperature, 25°C (77°F), out of the carton and exposed to light but must be used within 6 hours. Do not shake.