From the Guidelines
For a patient on rivaroxaban experiencing an active lower GI bleed in the UK, the recommended reversal agent is andexanet alfa, a specific urgent reversal agent for rivaroxaban and apixaban, which should be administered according to the dosing regimen based on the timing of the last rivaroxaban intake. The dosing of andexanet alfa depends on the DOAC and on the timing since last intake: for rivaroxaban (with the last intake > 7 h before reversal) or apixaban, a 400 mg bolus is administered followed by a 480 mg infusion (4 mg/min) 1. Andexanet alfa has been shown to decrease the median anti-FXa activity by 92% for both apixaban and rivaroxaban, with excellent or good hemostasis 12 hours after infusion, as demonstrated in the ANNEXA-4 trial 1.
Some key points to consider in the management of the patient include:
- Stopping rivaroxaban immediately
- Implementing fluid resuscitation and blood product transfusion as needed
- Identifying and treating the source of bleeding
- Closely monitoring the patient with regular hemoglobin checks and vital sign monitoring
- Considering the use of andexanet alfa as the first-line reversal agent for rivaroxaban-associated bleeding, given its specificity and efficacy in rapidly reversing anticoagulation 1.
It is essential to note that while prothrombin complex concentrate (PCC) may be considered in some cases, andexanet alfa is the preferred agent for reversing rivaroxaban due to its targeted mechanism of action and demonstrated efficacy in clinical trials 1.
From the FDA Drug Label
Active pathological bleeding ( 4)
The FDA drug label does not answer the question.
From the Research
Reversal of Rivaroxaban in Patients with Active Lower GI Bleed in the UK
- The management of bleeding in patients on oral factor Xa inhibitors, such as rivaroxaban, can be challenging 2, 3.
- Andexanet alfa is a specific reversal agent for factor Xa inhibitors, including rivaroxaban, and has been shown to be effective in reversing anticoagulation in patients with life-threatening or uncontrolled bleeding 3, 4.
- In the UK, the use of andexanet alfa for the reversal of rivaroxaban in patients with active lower GI bleed is not explicitly stated in the provided studies, but it is likely that andexanet alfa would be considered as a treatment option for patients with severe or life-threatening bleeding 3, 5.
- The studies suggest that andexanet alfa is effective in achieving hemostatic effectiveness and improving survival in patients with intracranial hemorrhage associated with apixaban or rivaroxaban 4, and may also be used for urgent or emergent reversal of apixaban and rivaroxaban prior to invasive or surgical procedures 5.
- However, the use of andexanet alfa remains a challenge due to its cost, reported thrombotic complications, and the fact that its efficacy mainly relates to intracranial hemorrhage 2.
Key Points
- Andexanet alfa is a specific reversal agent for factor Xa inhibitors, including rivaroxaban.
- Andexanet alfa has been shown to be effective in reversing anticoagulation in patients with life-threatening or uncontrolled bleeding.
- The use of andexanet alfa for the reversal of rivaroxaban in patients with active lower GI bleed in the UK is not explicitly stated in the provided studies.
- Andexanet alfa may be considered as a treatment option for patients with severe or life-threatening bleeding.