What adjustments are required for Xarelto (Rivaroxaban) dosing?

From the Guidelines

Xarelto (rivaroxaban) dosing needs to be adjusted primarily for renal function, as the drug is partially eliminated by the kidneys, with a recommended dose reduction from 20 mg once daily to 15 mg once daily for patients with a creatinine clearance (CrCl) between 15 and 30 mL/min, and is contraindicated in patients with CrCl less than 15 mL/min. For patients with creatinine clearance below 50 mL/min, dose reductions are typically required. The most recent and highest quality study 1 suggests that dose adjustments may be needed based on renal function, with specific recommendations for patients with CrCl between 15-30 mL/min. Additionally, dose adjustments may be needed based on indication, with different dosing for DVT/PE treatment versus prophylaxis. Body weight extremes, advanced age (>75 years), and concomitant use of certain medications (particularly P-glycoprotein and CYP3A4 inhibitors/inducers) may also warrant consideration for dose adjustment. These adjustments are necessary because altered drug metabolism or elimination can lead to either insufficient anticoagulation or increased bleeding risk if not properly managed. Some key points to consider when adjusting Xarelto dosing include:

• Renal function: CrCl is a critical factor in determining the appropriate dose of Xarelto, with dose reductions recommended for patients with CrCl between 15-30 mL/min, and contraindication in patients with CrCl less than 15 mL/min 1.
• Indication: Different dosing regimens may be recommended for different indications, such as DVT/PE treatment versus prophylaxis.
• Concomitant medications: Certain medications, such as P-glycoprotein and CYP3A4 inhibitors/inducers, may interact with Xarelto and require dose adjustments.
• Patient characteristics: Body weight extremes, advanced age (>75 years), and other patient characteristics may also require consideration when adjusting Xarelto dosing. It is essential to consult the most recent and highest quality study 1 for specific guidance on adjusting Xarelto dosing in various clinical scenarios.

From the FDA Drug Label

One approach is to discontinue XARELTO and begin both a parenteral anticoagulant and warfarin at the time the next dose of XARELTO would have been taken. For adult and pediatric patients currently taking XARELTO and transitioning to an anticoagulant with rapid onset, discontinue XARELTO and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next XARELTO dose would have been taken XARELTO should be stopped at least 24 hours before the procedure to reduce the risk of bleeding XARELTO should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established

XARELTO dose adjustments are needed in the following situations:

• Transitioning to or from other anticoagulants: XARELTO should be discontinued or started based on the timing of the next dose of the other anticoagulant.
• Surgery or other interventions: XARELTO should be stopped at least 24 hours before the procedure and restarted after the procedure when adequate hemostasis has been established.
• Missed doses: The patient should take the missed dose as soon as possible, but not double the dose within the same day.
• Administration options: XARELTO tablets may be crushed and mixed with applesauce or water for administration via NG tube or gastric feeding tube, but the dose should be immediately followed by food or enteral feeding for certain strengths. 2

From the Research

Xarelto Adjustments

Xarelto, also known as rivaroxaban, is a factor Xa inhibitor oral anticoagulant that requires adjustments in certain patient populations. The following are some of the factors that Xarelto needs to be adjusted for:

• Renal impairment: Patients with chronic kidney disease are at an increased risk of venous thromboembolism (VTE) and may require adjusted dosing of Xarelto 3, 4.
• Creatinine clearance: Patients with creatinine clearance (CrCl) < 30 mL/min may require adjusted dosing of Xarelto, although some studies suggest that the approved dosages can be used in patients with severe renal impairment 3, 5.
• Concomitant medications: The use of certain medications, such as verapamil, may increase the risk of bleeding in patients taking Xarelto and require adjusted dosing 6.
• Age and gender: Older adults and females may be at increased risk of bleeding when taking Xarelto and may require adjusted dosing 5.
• Heart failure: Patients with heart failure may be at increased risk of bleeding when taking Xarelto and may require adjusted dosing 5.

Patient Populations

Xarelto may need to be adjusted in the following patient populations:

• Patients with non-valvular atrial fibrillation: Xarelto may need to be adjusted in patients with non-valvular atrial fibrillation, particularly those with renal impairment or concomitant medications 4, 5.
• Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE): Xarelto may need to be adjusted in patients with DVT or PE, particularly those with renal impairment or concomitant medications 3, 4.
• Patients with chronic coronary artery disease or peripheral artery disease: Xarelto may need to be adjusted in patients with chronic coronary artery disease or peripheral artery disease, particularly those with renal impairment or concomitant medications 4.