ANDEXXA is an intravenous reversal agent for certain factor Xa blood thinners, specifically rivaroxaban and apixaban, used when a patient has life-threatening or uncontrolled bleeding. It is the brand name for coagulation factor Xa (recombinant), inactivated-zhzo.
What it does
ANDEXXA works by acting as a decoy factor Xa protein that binds anti-Xa anticoagulants, helping reverse their effect quickly in emergency bleeding situations. It was originally approved by the U.S. FDA under accelerated approval in 2018 for reversal of anticoagulation in patients treated with rivaroxaban or apixaban when urgent reversal was needed.
How it is used
The drug is given by intravenous infusion in hospital or emergency settings, and dosing depends on which factor Xa inhibitor the patient took, the dose taken, and how long ago it was taken. It is intended for severe bleeding scenarios, not routine use or general “blood thinning reversal” outside those indications.
Important safety issues
The FDA safety update states that postmarketing data showed serious thromboembolic events, including fatal outcomes, and that the agency considered the risks to outweigh the benefits. The FDA also reported that ANNEXA-I showed higher thrombosis rates and thrombosis-related deaths with ANDEXXA compared with usual care.
Current U.S. status
According to the FDA, AstraZeneca planned to end U.S. commercial sales by December 22, 2025, and ANDEXXA would no longer be manufactured for or sold in the U.S. by the company after that date. That means its availability may be limited or absent in the U.S. market depending on timing and stock.
Summary
ANDEXXA medication: uses, mechanism, and safety concerns
ANDEXXA is a specialized hospital medicine used to reverse the anticoagulant effects of apixaban and rivaroxaban in emergency bleeding cases. It is designed for patients with life-threatening or uncontrolled bleeding, where rapid reversal of anticoagulation is needed. The drug’s active component is a recombinant modified factor Xa protein that works as a decoy to trap factor Xa inhibitors and reduce their activity.pmc.ncbi.nlm.nih+3
Its clinical role is narrow but important. In real practice, it is used in urgent settings such as major internal bleeding or other critical hemorrhages when a patient has recently taken an anti-Xa anticoagulant. Because the medicine is given intravenously and requires careful dosing based on the specific blood thinner and timing of the last dose, it is generally administered in hospital settings by trained clinicians.pubmed.ncbi.nlm.nih+1
Safety has been a major concern. The FDA reported postmarketing thromboembolic events, including serious and fatal outcomes, and later stated that available data suggested the risks outweighed the benefits. The FDA’s safety communication also cited ANNEXA-I findings showing higher thrombosis and thrombosis-related death rates in the ANDEXXA group than in usual care.