Over 4 million people in the United States use Factor Xa Inhibitors such as Eliquis or Xarelto.These could be used for the prevention of thromboembolism and stroke, such as in patients with atrial fibrillation, treatment of a thrombosis or clot (Deep Vein Thrombosis or Pulmonary Embolism), and in those undergoing hip or knee replacement surgeries.


Before prescribing any medication as providers, we have to lay out the positives and negatives of each option clearly. Up until May 4th, there was no reversal agent for these medications, meaning that if there was a significant or abnormal bleed that occurred, there was no quick reversal to stop this, potentially threatening a patient’s life.


However, on May 4th the United States Food and Drug Administration approved AndexXa as the first factor Xa inhibitor reversal agent for cases of life-threatening and uncontrolled bleeding for patients on these medications.


Side note: Another big step regarding reversal agents for anticoagulants, was when the FDA approved Praxbind last month as a reversal agent for the medication Pradaxa, which is a direct thrombin inhibitor. This medication was approved for use in cases of life-threatening uncontrolled bleeding or in the need of emergency surgery in patients on Pradaxa.


The reversal agent [AndexXa] will allow primary care providers some extra confidence when prescribing Factor Xa Inhibitors.


In the United States, last year alone, there were over 110,000 patients admitted to the hospital, with an additional 2,000 deaths due to abnormal bleeding in patients on Factor Xa inhibitors.


With all the good which comes with this novel medication [AndexXa] , there is some caution. AndexXa does have black box warnings for cardiac arrest, ischemic events, risk of thromboembolism, and risk of sudden death.The most common adverse effects were urinary tract infections and pneumonia, which occurred in around 5 percent of patients that received the reversal agent.


Data on this novel medication was gained from the ANNEXA studies which showed a decreased effect of Xarelto (Rivaroxaban) by 97 percent and of Eliquis (Apixaban) by 92 percent after administration of AndexXa.1


The Food and Drug Administration also noted that in the current ongoing ANNEXA 4 study that adequate hemostasis was achieved within twelve hours after AndexXa administration in 83 percent of patient with uncontrolled bleeding on Eliquis or Xarelto.1


AndexXa expects to be released in June under the United States Food and Drug Administration’s early-supply program, and a larger medication distribution in early 2019.


The approval of AndexXa as the first Factor Xa inhibitor reversal agent is huge for medical providers. As mentioned above, this gives confidence to providers who are initially giving this medication to patients, and allows the clinician to let the patient know that if there was an abnormal bleeding event, that there will now be a reversal agent to aid in stopping said event.


It is also a tremendous tool for emergency medicine providers, if and when they run into a patient who presents with abnormal bleeding, secondary to Xarelto or Eliquis!




References


1. FDA Approves First Factor Xa Inhibitor Antidote, AndexXa. Medscape. May 04, 2018.


2. FDA approves AndexXa, first antidote for the reversal of factor Xa inhibitors. The Pharma Letter. May 4, 2018.


3. AndexXa. https://www.andexxa.com. Accessed: May 5, 2018.


4. ANNEXA-R: Novel Agent Sustains Anticoagulant Reversal from Rivaroxaban – Medscape – Nov 20, 2015


5. Antidote for Factor Xa Inhibitors Passes Another Test in ANNEXA-A Study – Medscape – Apr 08, 2015.


This article, blog, or podcast should not be used in any legal capacity whatsoever, including but not limited to establishing standard of care in a legal sense or as a basis of expert witness testimony. No guarantee is given regarding the accuracy of any statements or opinions made on the podcast or blog.