This information is intended for healthcare professionals based in Ireland.

Dosing for ELIQUIS® for VTE prevention in orthopaedic surgery

ELIQUIS®: convenient oral dosing

ELIQUIS® is an oral anticoagulant that offers a 12–24 hour post-surgery initiation window and BD dosing.1

The ELIQUIS® (apixaban 2.5mg tablets BD*) dosing regimen was specifically selected to increase VTE prevention without increasing bleeding risk vs. the OD regimen in patients undergoing total hip replacement (THR) and total knee replacement (TKR).2,3

ELIQUIS® dosing indications

ELIQUIS® 2.5 mg BD in all indicated patients for1:

  • Total knee replacement, 10–14 days
  • Total hip replacement, 32–38 days

ELIQUIS® features dosing that delivers multiple benefits

The initial dose of ELIQUIS® should be taken 12–24 hours after surgery,1 which allows:

  • Initiation the morning after surgery
  • Time to observe the patient after surgery before initiating anticoagulation
  • Time for haemostasis to advance before initiating anticoagulation4
  • Initiation when post-operative nausea and vomiting is less likely5

Post surgery initiation of the non-vitamin K oral anticoagulants

post surgery initiation of the new oral anticoagulants image

*Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window.
ƗProvided haemostasis has been established.

Rationale for BD dosing regimen:

  1. The selection of the ELIQUIS® 2.5 mg BD regimen was driven by the findings of the Phase II APROPOS study.2
    • This was not designed to detect efficacy and bleeding differences between OD and BD; however, analysis suggested that ELIQUIS® 2.5 mg BD had an improved balance of efficacy and safety vs. 5 mg OD
  2. Pharmacokinetic modelling suggested that the peak-to-trough ratio for ELIQUIS® 2.5 mg BD was lower than that for ELIQUIS® 5 mg OD.3

No dose adjustment in indicated patients

ELIQUIS® 2.5 mg BD in all indicated patients including1

eliquis (apixaban) 2.5 mg bd in all indicated patients image

Adapted from reference 1
*There is limited clinical experience in elderly patients co-administered ELIQUIS® with acetylsalicylic acid. This combination should be used cautiously because of a potentially higher bleeding risk.
**ELIQUIS® alone or in combination with acetylsalicylic acid should be used with caution in patients with severe renal impairment (CrCl 15–29 ml/min) because of a potentially higher risk of bleeding. ELIQUIS® is not recommended for use in patients with CrCl <15 ml/min. or in patients undergoing dialysis

Risk Minimisation Materials

The Eliquis (apixaban) Prescriber Guide and Patient Alert Card are risk minimisation materials developed for all indications as an aid to prescribing, in particular they are aimed at increasing awareness about the potential risk of bleeding during treatment with apixaban and providing guidance on how to manage that risk. Printed copies of these educational materials may be obtained by contacting the Bristol-Myers Squibb Medical Information Department (telephone: 1800 749 749; e-mail: medical.information@bms.com). Alternatively, electronic copies can be accessed via the HPRA website at http://www.hpra.ie/homepage/medicines/medicines-information/find-a-medicine.

References:

  1. ELIQUIS® (apixaban) Summary of Product Characteristics.
  2. Lassen MR, Davidson BL, Gallus A, et al. The efficacy and safety of apixaban, an oral direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement. J Thromb Haemost 2007;5(12):2368-2375.
  3. Leil TA, Feng Y, Zhang I, et al. Quantification of apixaban's therapeutic utility in prevention of venous thromboembolism: Selection of Phase III trial dose. Clin Pharmacol Ther 2010;88:375-382.
  4. Rosencher N, Bonnet MP, Sessler DI. Selected new antithrombotic agents and neuraxial anaesthesia for major orthopaedic surgery: management strategies. Anaesthesia 2007;62:1154-1160.
  5. Fareed J, Hull R. Apixaban to prevent venous thromboembolism after knee replacement. Lancet 2010;375:779-780.
  6. Pradaxa (dabigatran) Summary of Product Characteristics.
  7. Xarelto (rivaroxaban) Summary of Product Characteristics.