Should Xarelto (rivaroxaban) be held or administered in a patient with a wound exhibiting excessive hemorrhage and normal blood pressure?

From the Guidelines

If a patient on Xarelto (rivaroxaban) is experiencing larger than normal bleeding from a wound, the medication should be temporarily held, even if blood pressure remains normal, and andexanet alfa should be administered if available, as per the 2020 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants 1. Xarelto is an anticoagulant that inhibits blood clotting, and excessive bleeding is a concerning side effect that requires attention. The patient should seek medical evaluation promptly to assess the severity of bleeding and determine when it's safe to resume the medication. While holding Xarelto, the wound should be treated with direct pressure and appropriate wound care. Key considerations for the administration of andexanet alfa include the timing of the last dose of rivaroxaban, with low-dose andexanet alfa (400 mg IV bolus followed by 4 mg/min infusion for up to 120 minutes) recommended if the last dose was taken ≥8 hours prior, and high-dose andexanet alfa (800 mg IV bolus followed by 8 mg/min infusion for up to 120 minutes) recommended if the last dose was taken <8 hours prior or the timing is unknown 1. The decision to restart Xarelto should be made by a healthcare provider after the bleeding is controlled and the benefit-risk assessment is favorable. This cautious approach is necessary because Xarelto has a relatively short half-life (5-9 hours in healthy adults), and its anticoagulant effect will begin to diminish within 24 hours of the last dose. However, patients should never discontinue Xarelto without medical consultation due to the risk of thrombotic events, particularly if they're taking it for atrial fibrillation or venous thromboembolism. Some key points to consider when managing bleeding in patients on Xarelto include:

• The use of andexanet alfa as a reversal agent for rivaroxaban, as recommended by the 2020 ACC expert consensus decision pathway 1
• The importance of assessing the severity of bleeding and determining when it's safe to resume Xarelto
• The need for prompt medical evaluation and treatment of the wound with direct pressure and appropriate wound care
• The consideration of the timing of the last dose of rivaroxaban when determining the dose of andexanet alfa to administer.

From the FDA Drug Label

XARELTO is contraindicated in patients with: active pathological bleeding [see Warnings and Precautions (5. 2)] XARELTO increases the risk of bleeding and can cause serious or fatal bleeding. In deciding whether to prescribe XARELTO to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement Discontinue XARELTO in patients with active pathological hemorrhage.

Xarelto should be held in patients with a larger than normal amount of blood coming from their wound, as this indicates active pathological bleeding. The normal blood pressure does not change this assessment, as the primary concern is the bleeding itself. 2

From the Research

Management of Bleeding in Patients Taking Xarelto

• In patients taking Xarelto (rivaroxaban) who experience bleeding, the management strategy depends on the severity of the bleeding 3.
• For minor bleeding, temporary discontinuation of Xarelto may be sufficient, while for severe bleeding, Xarelto withdrawal and supportive measures such as blood product administration may be necessary 3.
• In cases of life-threatening bleeding, comprehensive hemostasis management, including the potential use of agents such as prothrombin complex concentrate, may be required 3.

Assessment of Bleeding Risk

• The risk of bleeding in patients taking Xarelto should be assessed on an individual basis, taking into account factors such as age, concomitant medications, and renal function 4.
• A dose of 10 mg once daily may be associated with a lower risk of bleeding in elderly patients with venous thromboembolism 4.
• The use of Xarelto in patients with a high risk of bleeding should be carefully considered, and alternative anticoagulation strategies may be necessary 5.

Comparison with Other Anticoagulants

• The risk of bleeding complications with Xarelto is similar to that of warfarin, and the management of bleeding in patients taking Xarelto is comparable to that of warfarin 5.
• Xarelto may have an advantage over warfarin in terms of the ease of reversal, with fewer patients requiring reversal agents 5.

Emergency Management

• In emergency situations, the management of bleeding in patients taking Xarelto should involve a thorough assessment of the patient's condition, including the severity of the bleeding and the presence of any underlying medical conditions 6.
• The use of hemostatic agents, such as tourniquets or hemostatic dressings, may be effective in controlling bleeding in patients taking Xarelto 7.