Usual Adult Dose for Reversal of Anticoagulation

5 g IV provided as two separate vials each containing 2.5 g/50 mL; administer as a bolus injection by injecting both vials consecutively one after another via syringe or as two consecutive infusions.

Comments:

• There is limited data to support administration of an additional 5 g.
• Resume anticoagulant therapy as soon as medically appropriate. Dabigatran can be initiated 24 hours after administration of this drug.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer as a bolus injection by injecting both vials consecutively one after another via syringe or as two consecutive infusions.
• Administration should begin promptly or within 1 hour after solution has been removed from the vial.

• Refrigerate at 2C to 8C (36F to 46F); do not freeze.
• Prior to use, unopened vials may be kept at room temperature (25C or 77F) for up to 48 hours if stored in the original package, or up to 6 hours if exposed to light.
• Do not shake.

• Do not mix with other medicinal products.
• A pre-existing IV line may be used but must be flushed with sterile 0.9% sodium chloride prior to and at the end of infusion.

• The safety and effectiveness of repeat treatment with this drug have not been established.
• This drug is specifically for dabigatran, with no impact on the effect of other anticoagulant or antithrombotic therapies.
• This drug can be used in conjunction with standard supportive measures.

• Inform patients to seek immediate medical attention for any signs or symptoms of bleeding.
• Inform patients of signs and symptoms of allergic hypersensitivity reactions (e.g., anaphylactoid reactions) that may be experienced during or after exposure to this drug.