![]() ![]() Transfer the ANDEXXA solution from the syringe into an empty polyolefin or polyvinyl chloride IV bag with a volume of 250 mL or less.ĭiscard the vials, including any unused portion. Note the total volume withdrawn into the syringe. 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. Upon reconstitution, the parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration. If dissolution is incomplete, discard the vial, and do not use the product. Typical dissolution time for each vial is approximately three to five minutes. Do not shake (B) shaking could lead to foaming. To ensure dissolution of the cake or powder, gently swirl each vial until complete dissolution of powder occurs (A). To reduce the total reconstitution time needed during preparation, reconstitute all required vials in succession. Slowly inject the SWFI, directing the solution onto the inside wall of the vial to minimize foaming. Use a 20-mL (or larger) syringe and 20-gauge (or higher) needle. Reconstitute the 200 mg vial of ANDEXXA with 20 mL of Sterile Water for Injection (SWFI). Table 2: ANDEXXA Dose Based on Rivaroxaban or Apixaban Dose (Timing of Last Dose of FXa Inhibitor before ANDEXXA Initiation) FXa Inhibitorĭetermine total number of vials required (see Table 1). 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). ![]() * The safety and effectiveness of more than one dose have not been evaluated. The safety and efficacy of an additional dose have not been established. There are two dosing regimens (see Table 1). ![]()
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