What is Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) for?

Buy Andexxa (recombinant). Andexxa is a drug that reverses the effects of certain blood thinners. It’s used for patients on rivaroxaban and apixaban when they need quick reversal of anticoagulation. This is for life-threatening or uncontrolled bleeding.

It comes in a powder form in single-use vials. The vials contain 200 mg or 100 mg of coagulation factor Xa (recombinant), inactivated-zhzo.

How does Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) work?

Factor Xa inhibitors like apixaban and rivaroxaban prevent blood clots. They work by blocking the action of FXa, a protein that helps blood clot. But, they can cause major bleeding.

Andexxa binds to FXa inhibitors, stopping their blood-thinning effect. This helps stop bleeding quickly.

Where has Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) been approved?

Andexxa has been approved for reversing the effects of rivaroxaban and apixaban. This is for patients with life-threatening or uncontrolled bleeding by:

• The Food and Drug Administration (FDA), USA, with accelerated approval on May 3, 2018.
• The European Medicines Agency (EMA), Europe, on April 26, 2019 under conditional marketing authorisation under the brand name Ondexxya (andexanet alfa).

This is the first antidote for apixaban- or rivaroxaban-treated patients with uncontrolled bleeding.

The FDA granted Andexxa with Orphan Drug and Breakthrough Therapy designations. This supports medicines for serious conditions and unmet medical needs.

The EMA granted approval under conditional marketing authorisation. This supports early access to medicines in the European Union.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) taken?

The standard dosage is:

• Low dose:
  • 400 mg, administered as an intravenous bolus at a target rate of 30 mg/min.
  • Followed by administration of a continuous infusion of 4 mg/min for up to 120 minutes (480 mg).
• High dose:
  • 800 mg, administered as an intravenous bolus at a target rate of 30 mg/min.
  • Followed by administration of a continuous infusion of 8 mg/min for 120 minutes (960 mg).

The recommended dosing of Andexxa is based on the specific FXa inhibitor (apaxiban or rivaroxaban), dose and time since the patient last took the FXa inhibitor.

Patients on anticoagulation drugs are at higher risk of blood clots. Using Andexxa increases this risk. To lower this risk, restarting anticoagulant therapy should be considered when safe.

For full details on Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) dosage and how to use it, check the official prescribing information. It’s in our references section.

Note: Always talk to your doctor for advice on the right dose for you.

Are there any known adverse reactions or side effects of Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo)?

Common adverse reactions

The most common side effects (affecting more than 5% of patients) are:

• Urinary tract infections
• Pneumonia

Serious adverse reactions

Here are the serious side effects mentioned in the prescribing information:

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

Use in a specific population

It’s not clear if Andexxa can harm an unborn baby. The maker doesn’t suggest using it during pregnancy.

For a full list of side effects and adverse reactions, see the official prescribing information.