Safety | Eliquis

In AMPLIFY, a study of initial and long-term Venous Thromboembolism treatment, The efficacy and safety of Eliquis® vs. Enoxaparin/warfarin was studied in 5,395 patients with DVT or PE (with or without DVT)³

*Enoxaparin followed by warfarin Adapted from Agnelli G, et al. N Engl J Med. 2013.

*There are no head-to-head randomised clinical trials comparing the NOACs. This analysis compared individual NOACs with warfarin. Comparisons cannot be made between individual NOACs based on these data.

Eliquis® compared to enoxaparin/warfarin, For the treatment of acute venous thromboembolism, the AMPLIFY study showed that a fixed-dose regimen of oral apixaban alone was as effective as conventional treatment consisting of enoxaparin followed by warfarin and was associated with a clinically relevant reduction of 69% in major bleeding.³

Eliquis® reduced the bleeding outcomes vs. enoxaparin/warfarin³

*Prespecified secondary safety endpoint.

AMPLIFY Trial: Major GI bleeding‡ outcomes³

*Not a defined endpoint per study protocol

AMPLIFY: Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy; BID: twice daily; CKD: chronic kidney disease;

CRNM: clinically relevant non-major bleeding; DVT: deep-vein thrombosis; GI: gastrointestinal; INR: International Normalized Ratio; PE: pulmonary embolism; SC: subcutaneous; RRR: relative risk reduction; VTE: venous thromboembolism.

References: 1. ELIQUIS® 2.5 mg/ 5 mg Egyptian Drug Authority approved leaflet 17/08/2022. Revision Date: February 2022. 2. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368(8:699-708. 3. Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(9:799-808.

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VTE treatment Dosing

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Click here for Eliquis® 2.5mg Prescribing Information Click here for Eliquis® 5mg Prescribing Information	HF0098OA455/122022 Invalidation Date : 21/08/2024

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SPAF Persistence and Adherence

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SPAF Aristophanes

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In AMPLIFY-EXT, a study of extended anticoagulant treatment beyond 6-12 months,
the efficacy and safety of eliquis® vs. Placebo was studied in 2,482 patients with DVT or PE (with or without DVT)²

This study showed that, as compared with placebo, both the 2.5-mg dose and the 5-mg dose of apixaban reduced the risk of recurrent venous thromboembolism (fatal or nonfatal). These benefits were observed with rates of major bleeding that were low and similar to those in the placebo group. Eliquis® was superior to placebo in protecting patients from Venous Thromboembolism recurrence, with a similar incidence of major bleeding.²

Eliquis® demonstrated similar incidences of bleeding (0.2% in the 2.5 mg apixaban and 0.1% in the 5mg apixaban group) vs. placebo (0.5%) across all protocol-defined bleeding endpoints (major bleeding and clinically relevant nonmajor bleeding).²

*Prespecified secondary safety endpoint.

AMPLIFY-EXT: Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism; BID: twice daily; CKD: chronic kidney disease; CRNM:
Clinically relevant non-major bleeding; DVT: deep-vein thrombosis; NS: nonsignificant; PE: pulmonary embolism; VTE: venous thromboembolism.

References: 1. ELIQUIS ® 2.5 mg/ 5 mg Egyptian Drug Authority approved leaflet 17/08/2022. Revision Date: February 2022. 2. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368(8:699-708.

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SPAF Aristophanes

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Click here for Eliquis® 2.5mg Prescribing Information Click here for Eliquis® 5mg Prescribing Information	HF0098OA455/122022 Invalidation Date : 21/08/2024

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SPAF Efficacy

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SPAF Dosing

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