This information is intended for healthcare professionals based in Ireland.

ELIQUIS® in VTE Treatment and Prevention of Recurrent DVT and PE

ELIQUIS® is indicated for the treatment of DVT and PE, and the prevention of recurrent DVT and PE, in adults.1

The marketing authorization for ELIQUIS® follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP), and is supported by two pivotal Phase 3 clinical trials, AMPLIFYand AMPLIFY-EXT.

AMPLIFY (ELIQUIS® for the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis as First-line Therapy) was designed to demonstrate the efficacy and safety of ELIQUIS® for the treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) versus standard of care (initial enoxaparin for at least five days overlapped by warfarin therapy [target International Normalized Ratio (INR) range 2.0-3.0] orally for six months).2

AMPLIFY-EXT (ELIQUIS® After the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-line Therapy-Extended Treatment) was designed to demonstrate the efficacy and safety of ELIQUIS® compared to placebo for the prevention of recurrent DVT and PE following six to 12 months of anticoagulant treatment for DVT and/or PE.3

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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. Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. New Engl J Med 2013;369:799-808.
  3. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. New Engl J Med 2013;368:699-708.