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ELIQUIS (apixaban) in VTE

A single oral treatment from the start

ELIQUIS (apixaban) is a single oral treatment that can be prescribed from the start in your patients with VTE and unlike dabigatran and edoxaban, doesn’t require initial treatment with LMWH.1–3

View the following video for an overview of how to prescribe ELIQUIS in your patients with VTE, for both treatment and secondary prevention of VTE.

ELIQUIS is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.



In summary, as shown, the dosing regimen requires high-dose treatment (ELIQUIS 10 mg BD) for only the first 7 days, with simple sequential dose reduction between treatment phases.*

ELIQUIS

ELIQUIS should be used with caution in patients with severe renal impairment (CrCl 15–29 ml/min) for the treatment of DVT / PE and prevention of recurrent DVT / PE. ELIQUIS is not recommended in patients with CrCl <15 ml/min, or in patients undergoing dialysis.

Not all patients who start on ELIQUIS for acute DVT / PE will stay on ELIQUIS; some acute DVT / PE patients who receive treatment do not require treatment for the prevention of recurrent DVT / PE. Other patients may be prescribed ELIQUIS for the prevention of recurrent VTE after initial treatment for acute DVT / PE with another anticoagulant. This is a decision for the prescribing clinician together with patient involvement in the decision-making.

[Reference for image: 1. Apixaban Summary of Product Characteristics. Accessed August 2019. Available at: www.medicines.org.uk/emc/product/2878/smpc.]

* As per medical guidelines, a short duration of treatment (at least 3 months) should be based on transient risk factors (e.g., recent surgery, trauma, or immobilisation).1 The duration of overall therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding.

To support you with initiating ELIQUIS in your patients with VTE you can use our DVT / PE Prescriber Checklist, available here.

Twice-daily dosing

ELIQUIS is taken twice-daily throughout treatment stages, providing your patients with VTE with a consistent dosing frequency whether they’re starting on ELIQUIS, or require extended therapy for prevention of recurrence. With a half-life of 12 hours, ELIQUIS twice-daily dosing gives your patients stable coverage throughout the day.4–6

Mean plasma concentration following multiple ELIQUIS doses4
Multiple ELIQUIS

A twice-daily regimen may reduce the pharmacokinetic impact of missing a dose. Data from another disease area show that, for agents with the same pharmacokinetic profile missing only one OD dose had the same impact on drug concentrations as missing two or three consecutive BD doses.7 However patients were only half as likely to miss two or three BD doses as one OD dose.7

PK / PD study design: the double-blind, randomised, placebo-controlled, parallel group, multiple-dose escalation study was conducted in six sequential dose panels – ELIQUIS 2.5, 5, 10 and 25 mg BD and 10 and 25 mg OD. Subjects were randomised to ELIQUIS or placebo for 7 days. Blood samples were taken to measure ELIQUIS plasma concentration and for coagulation tests.4

* 10 mg OD is not a licensed dose of ELIQUIS for treatment of DVT / PE or for prevention of recurrent DVT / PE, and is used only for illustrative purposes as it was the comparative dose in this dose-finding PK study.4

ELIQUIS licensed doses are: Treatment of DVT or PE 10 mg BD for the first 7 days, followed by 5 mg BD; and for the prevention of recurrent DVT and / or PE 2.5 mg BD, following 6 months of treatment.1

[Reference for image: 4. Frost C et al. Br J Clin Pharmacol 2013; 76: 776–786.]

Along with this simple twice-daily dosing, ELIQUIS can be taken with or without food.1

No dose adjustments

ELIQUIS can be used in a broad range of patients with VTE8,9 with no dose adjustments regardless of age, weight, or renal function.1*

* ELIQUIS should be used with caution in patients with severe renal impairment (CrCl 15–29 ml/min) for both the treatment of DVT / PE and prevention of recurrent DVT / PE.1 ELIQUIS is not recommended in patients with CrCl <15 ml/min, or in patients undergoing dialysis.1

NOAC dosing considerations

* Initial treatment phase: high NOAC dosage or initial parenteral anticoagulation as per the individual NOAC treatment regimen. Please refer to individual SmPCs for further information.
† The recommendation for the use of rivaroxaban 15 mg OD is based on PK modelling and has not been studied in the clinical setting. Patients should still be treated with 15 mg BD for the first 3 weeks.10
‡ For DVT / PE, this dosing recommendation is based on PK and PD analyses and has not been studied in this clinical setting.2

[References for image: 1. Apixaban Summary of Product Characteristics. Accessed August 2019. Available at: : www.medicines.org.uk/emc/product/2878/smpcSmPC. 2. Dabigatran Summary of Product Characteristics. Accessed August 2019. Available at: www.medicines.org.uk/emc/product/4703/smpc. 3. Edoxaban Summary of Product Characteristics. Accessed August 2019. Available at: www.medicines.org.uk/emc/product/6906/smpc. 10. Rivaroxaban Summary of Product Characteristics. Accessed August 2019. Available at: www.medicines.org.uk/emc/product/2793/smpc.]

Start and stay with ELIQUIS

Start and stay with ELIQUIS for the treatment and prevention of VTE.* As demonstrated in the AMPLIFY and AMPLIFY-EXT randomised controlled trials:

  • ELIQUIS demonstrated significant reductions in both the risk of major bleeding, and major or clinically relevant non-major bleeding, vs. enoxaparin / warfarin for the treatment of DVT / PE,8 and comparable major bleeding to placebo in the prevention of recurrent DVT / PE vs. placebo
  • ELIQUIS is comparable to enoxaparin / warfarin for the treatment of DVT / PE, and significantly more effective than placebo in the prevention of recurrent DVT / PE.8,11

* Not all patients who start on ELIQUIS for acute DVT / PE will stay on ELIQUIS; some acute DVT / PE patients who receive treatment do not require treatment for the prevention of recurrent DVT / PE. Other patients may be prescribed ELIQUIS for the prevention of recurrent VTE after initial treatment for acute DVT / PE with another anticoagulant.1 This is a decision for the prescribing clinician together with patient involvement in the decision-making.




Click here to view ELIQUIS (apixaban) prescribing and adverse event reporting information.

Abbreviations

AF = Atrial Fibrillation BD = Twice Daily DVT = Deep Vein Thrombosis LMWH = Low Molecular Weight Heparin NOAC = Non-vitamin K antagonist Oral Anticoagulant OD = Once Daily PE = Pulmonary Embolism VTE = Venous Thromboembolism

References
  1. Apixaban Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/2878/smpc. Accessed August 2019.
  2. Dabigatran Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/4703/smpc. Accessed August 2019.
  3. Edoxaban Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/6906/smpc. Accessed August 2019.
  4. Frost C et al. Br J Clin Pharmacol 2013; 76: 776–786.
  5. Lassen MR et al. J Thromb Haemost 2007; 5: 2368–2375.
  6. Leil TA et al. Clin Pharmacol Ther 2010; 88: 375–382.
  7. Comte L et al. J Pharmacokinet Pharmacodyn 2007; 34: 549–558.
  8. Agnelli G et al. N Eng J Med 2013; 369: 799–808.
  9. Agnelli G et al. N Eng J Med 2013; 369: 799–808. Supplementary appendix.
  10. Rivaroxaban Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/2793/smpc. Accessed August 2019.
  11. Agnelli G et al. N Eng J Med 2013; 368: 699–708.

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Job code: 432UK1900506-01
Date of preparation: September 2019

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