Key result
Andexanet alfa is a safe and effective option for the reversal of apixaban and rivaroxaban, though its use for enoxaparin or edoxaban is limited by a lack of FDA approval.
Why the study?
To review the available clinical trial data for andexanet alfa and evaluate its role in clinical practice.
Does andexanet alfa safely and effectively reverse apixaban and rivaroxaban?
Does andexanet alfa safely and effectively reverse apixaban and rivaroxaban?
Andexanet alfa provides a safe and effective FDA-approved option for reversing apixaban and rivaroxaban, potentially increasing provider comfort in prescribing these direct oral anticoagulants.
Supports andexanet alfa for approved reversals; leaves open broader use pending higher-level trials and expanded approvals.
Objective: The purpose of this article is to review the available clinical trial data for andexanet alfa and its role in clinical practice. Data Sources: A MEDLINE/PubMed search was conducted (January 2000 to January 2019) using the keyword andexanet alfa for clinical trials. References of identified articles were searched by hand for additional citations. Study Selection and Data Extraction: We included English-language articles related to the Food and Drug Administration (FDA) approval of andexanet alfa or provided novel information regarding this drug entity. Data Synthesis: The findings of the review show that andexanet alfa may be a safe and effective option for the reversal of apixaban and rivaroxaban. Relevance to Patient Care and Clinical Practice: With the approval of this reversal agent, patients and providers can feel safer when using apixaban and rivaroxaban, which in turn may increase the use of these anticoagulant agents. Conclusions: The new FDA approval of andexanet alfa will allow safer use of oral anticoagulants and will likely further the use of direct oral anticoagulants for anticoagulant needs. Reversing enoxaparin-/edoxaban-induced bleeding with this agent should be limited because there is no FDA approval owing to the fact that only phase II trial data available.
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Powell et al. (2019) conducted a review in Factor Xa inhibitor reversal. Andexanet alfa was evaluated. Andexanet alfa is a safe and effective option for the reversal of apixaban and rivaroxaban, though its use for enoxaparin or edoxaban is limited by a lack of FDA approval.
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