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Andexxa was initially granted accelerated approval in May 2018 for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation was needed due to life-threatening or uncontrolled bleeding.
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If Tybost is given with atazanavir or darunavir, coadministration with rivaroxaban is not recommended due to a potentially increased bleeding risk.
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Andexxa, a recombinant modified human Factor Xa (FXa) protein, was approved under the FDA's Accelerated Approval pathway.
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The greatest risk reduction of stroke or systemic embolism was seen with dabigatran 150mg twice daily (odds ratio [OR] 0.65, 95% CI: 0.52-0.81), followed by apixaban 5mg twice daily (OR 0.79, 95% CI: 0.66-0.94).
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Patients taking apixaban showed significantly less intracranial hemorrhage (0.33% per year) vs. patients taking warfarin (0.80% per year) no matter the type and location.
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Findings from a study published in the British Journal of Clinical Pharmacology showed that apixaban appeared to be an appropriate alternative to warfarin for patients with severe renal impairment.
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The American College of Chest Physicians has released the latest evidence-based guideline with updated recommendations for appropriate treatment of patients with venous thromboembolism (VTE).