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FDA Approves Edoxaban (Savaysa®)

Darrell Hulisz, RPh, PhamD
Kirsten Donnan

February 2, 2015

Edoxaban (Savaysa®) is a highly specific inhibitor of factor Xa in the clotting cascade. It was approved by the FDA on January 8th, 2015 for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for treatment of deep vein thrombosis and pulmonary embolism. Edoxaban was first introduced in Japan as Lixiana® to prevent venous thromboembolism in patients receiving hip and knee replacements as well as hip fracture surgeries. Savaysa® falls into the same class of drugs as rivaroxaban (Xarelto®), apixaban (Eliquis®), and fondaparinux (Arixtra® ).

The FDA approval includes three different doses of Savaysa® 60, 30, and 15 mg doses based on kidney function. All three strengths will be available as oral film-coated tablets.The dose for patients with a creatinine clearance between 50 and 95 ml/min is 60 mg once daily and 30 mg once daily in patients with moderate to severe renal impairment with a creatinine clearance of 15-50 ml/min. The FDA also included a black box warning for use in patients with normal renal function (CrCl greater than 95 ml/min) due to a decrease in efficacy of the drug. Additional black box warnings include the increased risk of ischemic events when edoxaban is discontinued early and spinal hematomas following epidurals.

The most common side effects of edoxaban are bleeding and anemia. Life threatening bleeding is the biggest risk and there is no proven way to reverse the effects of edoxaban. Like many anticoagulants, Edoxaban is contraindicated in patients with active bleeding. Major drug interactions include strong P-glycoprotein substrates such as verapamil, quinidine, and dronedarone. These drugs will increase the total exposure to edoxaban and increase the risk of bleeding.

In clinical trials edoxaban has been shown to be equivalent, or more specifically non-inferior to warfarin, but with a lower overall risk of bleeding. It is unclear at this time what advantages this drug has over existing oral Factor Xa inhibitors.

1. FDA News Release. FDA approves anti-clotting drug Savaysa. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm Accessed on January 22, 2014.

2. Hughes GJ and Hilas O. Edoxaban: an investigational factor Xa inhibitor. P&T 2014;39(10):686-715.

3. Lexi-Comp, Lexi-Drugs Online® . Retrieved from http://online.lexi.com Hudson, OH: Lexi-Comp, Inc. Accessed on January 22, 2014.

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