ANDEXXA

ANDEXXA- andexanet alfa injection, powder, lyophilized, for solution
Alexion Pharmaceuticals, Inc.

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: (5.1)

  • Arterial and venous thromboembolic events
  • Ischemic events, including myocardial infarction and ischemic stroke
  • Cardiac arrest
  • Sudden deaths

Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

1 INDICATIONS AND USAGE

ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14)]. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.

Limitations of Use

ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.

2 DOSAGE AND ADMINISTRATION

For intravenous (IV) use only.

2.1 Dose

There are two dosing regimens (see Table 1). The safety and efficacy of an additional dose have not been established.

Table 1: ANDEXXA Dosing Regimens
Dose * Initial IV Bolus Follow-On IV Infusion Total Number of 200 mg Vials
*
The safety and effectiveness of more than one dose have not been evaluated.
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 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 (see Table 2).

Table 2: ANDEXXA Dose Based on Rivaroxaban or Apixaban Dose (Timing of Last Dose of FXa Inhibitor before ANDEXXA Initiation)
FXa Inhibitor FXa Inhibitor Last Dose < 8 Hours or Unknown ≥ 8 Hours
Rivaroxaban ≤ 10 mg Low Dose Low Dose
> 10 mg or Unknown High Dose
Apixaban ≤ 5 mg Low Dose
> 5 mg or Unknown High Dose

2.2 Reconstitution

  • 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.

IV Bolus Preparation

Determine total number of vials required (see Table 1).200 mg vials:Reconstitute the 200 mg vial of ANDEXXA with 20 mL of Sterile Water for Injection (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 minimize foaming.To reduce the total reconstitution time needed during preparation, reconstitute all required vials in succession.Figure
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 three to five 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. (A) (B)
Figure AFigure B
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.Figure

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 protein-binding filter.

2.3 Administration

  • 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.
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