Step-by-step dosing & administration1

For dosing, choose either the low dose or high dose based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient's last dose per the guidelines below. ANDEXXA® is administered using an initial IV bolus followed by a continuous IV infusion.

3D red-blue horshoe-shaped magnet lying flat, to represent Andexxa's power to draw out FXa inhibitors 3D red-blue horshoe-shaped magnet lying flat, to represent Andexxa's power to draw out FXa inhibitors
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Dosing Calculator

Use the dosing calculator to determine the proper dosage of ANDEXXA

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Review specific dosing and reconstitution guidelines​

There are two dosing regimens. The safety and efficacy of an additional dose have not been established.

ANDEXXA Dosing Regimens*

Dose* Initial IV Bolus Follow-On IV Infusion Total Number of 200 mg Vials
Low Dose 400 mg at a target rate of 30 mg/min 4 mg/min for up to 120 minutes (480 mg) 5 (2 vials bolus + 3 vials infusion)
High Dose 800 mg at a target rate of 30 mg/min 8 mg/min for up to 120 minutes (960 mg) 9 (4 vials bolus + 5 vials infusion)
*The safety and effectiveness of more than one dose have not been evaluated.

Determining the right ANDEXXA dose​​

The recommended dosing of ANDEXXA is based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient’s last dose of FXa inhibitor

Drug
FXa Inhibitor
Dose
Strength of Last Dose
Time
Since Last Dose Taken
<8 Hours or Unknown ≥8 Hours
ELIQUIS®
(apixaban)
≤5mg Low Dose Low Dose
>5 mg or Unknown High Dose Low Dose
XARELTO®
(rivaroxban)
≤10 mg Low Dose Low Dose
>10 mg or Unknown High Dose Low Dose

How to reconstitute ANDEXXA

Gloved hand holding vial of clear liquid being penetrated by a syringe to show the first step in Andexxa reconstitution

IV bolus preparation

200-mg vials: reconstitute the 200-mg vial of ANDEXXA with 20 mL of Sterile Water for Injection (SWFI).

  • Use a 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 minimize foaming
  • To reduce the total reconstitution time needed during preparation, reconstitute all required vials in succession
Two gloved hands encasing an Andexxa vial overlaid with directional arrows to show how to swirl the mixture without foaming
  • 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
Gloved hand holding Andexxa vial between thumb and forefinger with up, down arrows overlaid with red X to show wrong way
  • Use a 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 drawn 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, per your institutions’ biohazard disposal policies
  • 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 protein-binding filter

Administration of ANDEXXA

Single syringe representing the administration of Andexxa through first a bolus IV injection followed by a continuous IV infusion
  • 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 2 minutes following the bolus dose, administer the continuous IV infusion for up to 120 minutes

Storage of ANDEXXA*

Single Andexxa vial representing packaging, with guidance on how the reconstituted solution works
  • Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.

Restarting anticoagulant therapy

Single pill capsule to visualize guidance on re-starting antithrombotic therapy to treat underlying disease
  • 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.
References:
1. Andexxa (prescribing information). South San Francisco, CA: Portola Pharmaceuticals, Inc.; 2020.