For intravenous use only.
2.1 Recommended Dose
The recommended dose of PRAXBIND is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1).
There is limited data to support administration of an additional 5 g of PRAXBIND [see Warnings and Precautions (5.2)].
2.2 Preparation
Ensure aseptic handling when preparing the infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Once solution has been removed from the vial, administration should begin promptly or within 1 hour.
2.3 Administration
Do not mix with other medicinal products. Use aseptic technique when administering PRAXBIND.
Intravenously administer the dose of 5 g (2 vials, each contains 2.5 g) as
Two consecutive infusions (see Figure 2) or
Bolus injection by injecting both vials consecutively one after another via syringe (see Figure 3).
A pre-existing intravenous line may be used for administration of PRAXBIND. The line must be flushed with sterile 0.9% Sodium Chloride Injection, USP solution prior to infusion. No other infusion should be administered in parallel via the same intravenous access.
PRAXBIND treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate [see Clinical Pharmacology (12.2)].
2.4 Restarting Antithrombotic Therapy
Patients being treated with dabigatran therapy have underlying disease states that predispose them to thromboembolic events. Reversing dabigatran 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.
Idarucizumab is a specific reversal agent for dabigatran, with no impact on the effect of other anticoagulant or antithrombotic therapies.
Pradaxa treatment can be initiated 24 hours after administration of PRAXBIND [see Clinical Pharmacology (12.2)].
