THERAPEUTICS

Brands

• Savaysa

Generic?

• No

Class

• Anticoagulant

Commonly Prescribed for

(FDA approved in bold)

• To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF)

• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with a parenteral anticoagulant

• Prevention of DVT and PE

• Treatment of cerebral venous thrombosis

How the Drug Works

• Edoxaban is a selective inhibitor of the enzyme factor Xa (Stuart-Prower factor), which is the first member of the final common pathway of coagulation. It does not require antithrombin III for antithrombotic activity. It inhibits free factor Xa, and prothrombinase activity and inhibits thrombin-induced platelet aggregation. Inhibition of factor Xa in the coagulation cascade reduces thrombin generation and reduces thrombus formation

How Long Until It Works

• Peak effect in 1–2 hours

If It Works

• Monitor for signs of bleeding. Assess renal function periodically as clinically indicated

If It Doesn't Work

• Correct the underlying disorder. Use a higher dose or switch to different anticoagulant

Best Augmenting Combos for Partial Response or Treatment-Resistance

• Combining with antiplatelet agent may not always improve efficacy but definitely increases bleeding risk

Tests

• The degree of anticoagulation does not need to be assessed; PT, aPTT highly variable

• Assess renal function (CrCl) regularly

ADVERSE EFFECTS (AEs)

How the Drug Causes AEs

• Reduced coagulation due to inhibited thrombin formation

Notable AEs

• Bleeding, nausea/vomiting, constipation, abnormal liver function test, rash

Life-Threatening or Dangerous AEs

• From clinical trials, the yearly incidence of major bleeding is 3.1%, intracranial hemorrhage is 0.5%, GI bleeding 1.8%, and fatal bleeding (mostly intracranial hemorrhage) is 0.2%. Non-major bleeding 9.4%

Weight Gain

• Unusual

Sedation

• Unusual

What to Do About AEs

• Discontinue treatment, supportive care. Activated charcoal may reduce absorption

• Not effective: vitamin K, protamine sulfate, tranexamic acid, and hemodialysis