Andexanet alfa
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
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.
WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, and SUDDEN DEATHS See full prescribing information for complete boxed warning 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.
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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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 (36°F to 46°F).
Reconstituted ANDEXXA in IV bags is stable at room temperature for up to eight hours. IV Bolus Preparation [See table below.] Discard the syringe and needle. Discard the vials, including any unused portion. Figure figure a figure B figure II 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
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 120 minutes.
| DoseThe safety and effectiveness of more than one dose have not been evaluated. (2.1) | Initial IV Bolus | Follow-On IV Infusion |
|---|---|---|
| Low Dose | 400 mg at a target rate of 30 mg/min | 4 mg/min for 120 minutes |
| High Dose | 800 mg at a target rate of 30 mg/min | 8 mg/min for 120 minutes |
| DoseThe safety and effectiveness of more than one dose have not been evaluated. | 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 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 120 minutes (960 mg) | 9 (4 vials bolus + 5 vials infusion) |
| 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 smaller in diameter, e.g., 21-gauge) 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. | ||
| 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) |
| Use 40-mL (or larger) syringe with a 20-gauge (or smaller in diameter, e.g., 21-gauge) needle to withdraw the reconstituted ANDEXXA solution from each of the vials until the required dosing volumeis 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. | ||
Drug interactions
Check andexanet alfa against a medication listLabel text (3 paragraphs)
Do not use unfractionated heparin following ANDEXXA administration due to unresponsiveness characterized by non-prolongation of activated clotting times ( 7.1 ). See full prescribing information for details on drug interactions.
7.1 Use with Unfractionated Heparin Unresponsiveness to unfractionated heparin has occurred following ANDEXXA administration, characterized by non-prolongation of activated clotting times and requirement for increased dosing of heparin. Do not use unfractionated heparin following ANDEXXA administration.
7.2 Interference with Anti-FXa Activity Test Current commercial clinical anti-FXa-activity assays are unsuitable for measuring FXa activity following administration of ANDEXXA. Due to the reversible binding of ANDEXXA to the FXa inhibitor, the high sample dilution currently used in commercial clinical assays promotes dissociation of the inhibitor from ANDEXXA, resulting in detection of erroneously elevated anti-FXa activity levels, thereby causing a underestimation of the reversal activity of ANDEXXA.
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of ANDEXXA in pregnant women to inform patients of associated risks. Animal reproductive and developmental studies have not been conducted with ANDEXXA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Labor or Delivery The safety and effectiveness of ANDEXXA during labor and delivery have not been evaluated.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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