Dosing of Andexxa
Reconstitution of Andexxa*
IV Bolus Preparation
200 mg vials:
Reconstitute the 200 mg vial of ANDEXXA with 20 mL of Sterile
Water for Injection USP (SWFI).
- Use a 20-mL (or larger) syringe and 20-gauge (or higher) needle.
- Slowly inject the SWFI directing the solution onto the inside wall of the vial to
- To reduce the total reconstitution time needed during preparation, reconstitute all
required vials in succession.
- To ensure dissolution of the cake or powder, gently swirl each vial until complete
dissolution of powder occurs (A). Do not shake (B); shaking could lead to foaming.
Typical dissolution time for each vial is approximately 3 to 5 minutes. If dissolution
is incomplete, discard the vial and do not use the product.
- Upon reconstitution, the parenteral drug product should be inspected visually for
particulate matter and discoloration prior to administration.
- Use 60-mL or larger syringe with a 20-gauge (or higher) needle to withdraw the
reconstituted ANDEXXA solution from each of the vials until the required dosing volume
is achieved. Note the total volume withdrawn into the syringe.
- Transfer the ANDEXXA solution from the syringe into an empty polyolefin or polyvinyl
chloride IV bag with a volume of 250 mL or less.
- Discard the syringe and needle.
- Discard the vials, including any unused portion.
Continuous IV Infusion Preparation
- Follow the same procedure outlined above for IV bolus preparation. Reconstitute the
total number of vials needed based on the dose requirements. More than one 40 to 60-mL
syringe, or an equivalent 100-mL syringe, may be used for transfer of reconstituted
solution to the IV bag.
- Infusion will require a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low
Administration of Andexxa
- Upon reconstitution, the parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration.
- Administer ANDEXXA intravenously, using a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low protein-binding filter.
- Start the bolus at a target rate of approximately 30 mg/min.
- Within two minutes following the bolus dose, administer the continuous IV infusion for up to 120 minutes.
Storage of Andexxa*
- The reconstituted solution contains coagulation factor Xa (recombinant), inactivated-zhzo at a concentration of 10 mg/mL.
- Reconstituted ANDEXXA in vials is stable at room temperature for up to eight hours, or may be stored for up to 24 hours at 2°C to 8°C
- Reconstituted ANDEXXA in IV bags is stable at room temperature for up to eight hours.
Restarting Antithrombotic Therapy
- Patients treated with FXa inhibitor therapy have underlying disease states that predispose them to thromboembolic events.
- Reversing FXa inhibitor therapy exposes patients to the thrombotic risk of their underlying disease.
- To reduce the risk of thrombosis, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA.
*Note: Andexxa does not need to be brought to room temperature before reconstitution or administration to the patient.