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Dosing and Administration for DVT Prophylaxis After Knee or Hip Replacement Surgery

Convenient, oral dosing with no routine coagulation monitoring

XARELTO® offers convenient, oral, once-daily dosing and administration with no routine coagulation monitoring.1-4 XARELTO® provides a consistent approach to protecting against deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) after knee or hip replacement surgery, after discharge and during recovery.

XARELTO®offers 10-mg once-daily dosing for DVT prophylaxis after knee (12 days) or hip (35 days) replacement surgery

Renal dosing considerations

  • DVT prophylaxis after knee or hip replacement surgery: Avoid using XARELTO® in patients with CrCl <30 mL/min

 

Please see full Prescribing Information for additional dosing considerations.

Temporary discontinuation for surgery and other procedures

If XARELTO® must be discontinued for a procedure, follow these guidelines:

Before procedure:

  • Stop XARELTO® at least 24 hours before the procedure

  • In deciding whether a procedure should be delayed until 24 hours after the last dose of XARELTO®, the increased risk of bleeding should be weighed against the urgency of intervention

After procedure:

  • Restart XARELTO® as soon as adequate hemostasis is established, noting that the time to onset of therapeutic effect is short

  • If oral medication cannot be taken during or after surgical procedures, consider a parenteral anticoagulant

Note that the half-life of XARELTO® is 5 to 9 hours in healthy subjects aged 20 to 45 years and 11 to 13 hours in the elderly.

Other administration options

For patients who are unable to swallow whole tablets:

  • Crush and mix a 10-mg XARELTO® tablet with applesauce immediately prior to use and administer orally

For administration via NG tube or gastric feeding tube:

  • Confirm gastric placement of the tube, then crush a 10-mg XARELTO® tablet, suspend in 50 mL of water, and administer via an NG tube or gastric feeding tube

  • Avoid administering XARELTO® distal to the stomach, which can result in reduced absorption and, thereby, reduced drug exposure

CrCl = creatinine clearance.

 

Indications

 

IMPORTANT SAFETY INFORMATION

 

Indication and Important saftey Information

 

  • Reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). There are limited data on the relative effectiveness of XARELTO® (rivaroxaban) and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.
  • Treatment of deep vein thrombosis (DVT).
  • Treatment of pulmonary embolism (PE).
  • Reduction in the risk of recurrence of DVT and of PE following initial 6 months treatment for DVT and/or PE.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing knee replacement surgery.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing hip replacement surgery.

References:

  1. Mueck W, Eriksson BI, Bauer KA, et al. Population pharmacokinetics and pharmacodynamics of rivaroxaban – an oral, direct Factor Xa inhibitor – in patients undergoing major orthopaedic surgery. Clin Pharmacokinet. 2008;47(3):203-216.
  2. Lassen MR, Ageno W, Borris LC, et al; for the RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
  3. Eriksson BI, Borris LC, Friedman RJ, et al; for the RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  4. Kakkar AK, Brenner B, Dahl OE, et al; for the RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.