![]() ![]() In the emergency room, the neurosurgeon delayed operating on Sharyn’s skull because he didn’t know how much Xarelto was circulating in her body.Īt trial, the plaintiff’s attorney argued that Sharyn died because she took Xarelto and because the manufacturer failed to include necessary safety labels on the medication. The lawsuit also alleged that Janssen Pharmaceuticals failed to state on the label that a prothrombin time (PT) test would reveal how much Xarelto was in the patient’s blood. The lawsuit alleged that Xarelto was unreasonably dangerous. Sharyn’s husband, Joseph Orr, filed a wrongful death lawsuit against Janssen Pharmaceuticals. Andexanet alfa has not been adequately studied in pregnant patients no information is available regarding its presence in breast milk.Sharyn Orr, an academic advisor at Tulane University for over 40 years, took Xarelto and later died of a hemorrhagic stroke (bleeding in the brain).They should also be instructed to seek medical attention for other symptoms such as leg swelling, pain, warmth, erythema, dyspnea, pallor, or paresthesia. They should be instructed to call 911 if they develop acute symptoms suggestive of thromboembolic event, such as persistent cough, chest pain or pressure, lower stomach or pelvic pain, unilateral weakness or facial drooping, difficulty thinking or speaking, blurred vision, or blood in the sputum or urine. Prior to hospital discharge, patients should be counseled regarding the risk of thromboembolic events.In clinical trials, the other most common adverse reactions included local infusion site reactions, urinary tract infections, and pneumonia. Patients should be monitored for signs and symptoms of thromboembolic events. Thromboembolic events, including ischemic events, cardiac events, and sudden death, have occurred during andexanet alfa treatment and within 30 days after treatment.Anticoagulation should be resumed as soon as medically appropriate following andexanet alfa therapy.The high-dose regimen is 800 mg intravenously (at a target dose of 30 mg/min) followed by an infusion of 8 mg/min for up to 2 hours.The low-dose regimen is 400 mg intravenously (at a target rate of 30 mg/min) followed by an infusion of 4 mg/min for up to 2 hours.The indicated dosage of andexanet alfa depends on the FXa inhibitor, FXa inhibitor dosage, and time since last FXa inhibitor dose:.It restored thrombin generation in 100% of patients within 2-5 minutes. In clinical trials, andexanet alfa decreased anti-FXa activity by 94% and 92% in patients on apixaban and rivaroxaban, respectively.Andexanet alfa is a modified recombinant human factor Xa (FXa) decoy protein that binds and sequesters apixaban or rivaroxaban it also binds and inhibits tissue factor pathway inhibitor.It also recommends off-label use of andexanet alfa for reversal of edoxaban or betrixaban. If andexanet alfa is not available, the “2020 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants” recommends administration of prothrombin complex concentrate or activated prothrombin complex.Andexanet alfa is approved for patients taking apixaban or rivaroxaban who require reversal of anticoagulation due to life-threatening or uncontrolled bleeding.Availability of these agents improves the overall safety of direct oral anticoagulants. The US Food and Drug Administration has approved specific antidotes for apixaban, rivaroxaban, and dabigatran.Direct oral anticoagulants, including apixaban, rivaroxaban, edoxaban, betrixaban, and dabigatran, have many advantages over warfarin, yet patients are still at risk for hemorrhagic events.The following are key points to remember about this review of andexanet alfa for reversing the anticoagulant effects of apixaban or rivaroxaban: ![]()
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