DOSING, PREP & ADMINISTRATION:

One Recommended Dose for All PRADAXA Patients

For intravenous use only.

Ready to use immediately

  • The recommended dose of PRAXBIND is 5 g, provided as two separate 50 mL vials, each containing 2.5 g
  • There are limited data to support administration of an additional 5 g of PRAXBIND
  • No reconstitution needed

Preparation

  • Ensure aseptic handling when preparing and administering 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
PRAXBIND vial for dosing, prep and administration

Flexible administration for immediate reversal

  • Do not mix with other medicinal products
  • A pre-existing intravenous line may be used for administration of PRAXBIND. The line must be flushed with 0.9% Sodium Chloride Injection, USP solution prior to infusion. No other infusion should be administered in parallel via the same intravenous access
Option 1: Infusion PRAXBIND Administration Option 1: Intravenous Infusion
  • Hang vials and administer as 2 consecutive infusions
Option 2: Bolus Injection PRAXBIND Administration Option 2: Bolus Injection
  • Inject both vials consecutively via syringe

PRAXBIND treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate.

Restarting PRADAXA

Patients treated with Pradaxa® (dabigatran etexilate) therapy have underlying diseases that predispose them to thromboembolic events. Reversing PRADAXA 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.

PRAXBIND is a specific reversal agent for PRADAXA, with no impact on the effect of other anticoagulant or antithrombotic therapies.

PRADAXA can be re-initiated after 24 hours following PRAXBIND administration.