An investigational antidote, andexanet alfa, was proven to reverse the anti-coagulation activity of apixaben. The US Food and Drug Administration gave the antidote "breakthrough therapy" status, according to MD Magazine.
The antidote is significant for patients who have had knee or hip replacement who are prescribed apixaban.
Here are five notes:
1. In the first part of the study, 33 healthy volunteers were given apixaben 5 mg twice a day for four days. Patients were then randomized to get the drug in a 400 mg IV bolus or placebo.
2. In the second portion of the study, 31 healthy volunteers received apixaben 5 g twice daily for four days. They were also randomized to get the same bolus followed by a continuous infusion of 4 mg/min for two hours or placebo.
3. Results revealed the bolus had a 93.5 percent reversal of anticoagulation. The reversal effect remained at 92.7 percent of the anticoagulant activity two hours after the infusion.
4. John Curnutte, MD, PhD, explained the antidote can quickly reverse anticoagulant activity for a short duration of time while allowing anticoagulant activity to begin again once the infusion is discontinued.
5. Risks include bleeding and development of epidural or spinal hematomas in patients getting spinal or epidural anesthesia.
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