FDA approves anti-clotting drug EDOXABAN(SAVAYSA)

  • Approval Date: January 8, 2015
  • EDOXABAN  is a factor Xa inhibitor.
  • It is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation.
  •  SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant.
  • Edoxaban, a factor Xa inhibitor, is supplied as edoxaban tosylate monohydrate. The chemical name is N-(5-Chloropyridin-2-yl)-N-[(1S,2R,4S)-4-(N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzenesulfonate) monohydrate. Edoxaban tosylate monohydrate has the empirical formula C24H30ClN7O4S•C7H8O3S•H2O representing a molecular weight of 738.27. The chemical structure of edoxaban tosylate monohydrate is:

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———————————–Mechanism of Action ————————————–

  • Edoxaban is a selective inhibitor of FXa. It does not require antithrombin III for antithrombotic activity.
  • Edoxaban inhibits free FXa, and prothrombinase activity and inhibits thrombin-induced platelet aggregation.
  • Inhibition of FXa in the coagulation cascade reduces thrombin generation and reduces thrombus formation.

—————————-DOSAGE AND ADMINISTRATION———————————–

  • Treatment of NVAF:
    • Assess CrCL before initiating therapy
    • The recommended dose is 60 mg once daily in patients with CrCL >50 to ≤ 95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min
    • Reduce dose to 30 mg once daily in patients with creatinine clearance 15 to 50 mL/min
  • Treatment of DVT and PE:
    • The recommended dose is 60 mg once daily.
    • The recommended dose is 30 mg once daily for patients with CrCL 15 to 50 mL/min or body weight less than or equal to 60 kg or who use certain P-gp inhibitors.

—————————- DOSAGE FORMS AND STRENGTHS ——————————–

  • Tablets: 60 mg, 30 mg, and 15 mg.

—————————————CONTRAINDICATIONS ————————————

  • Active pathological bleeding.

——————————–WARNINGS AND PRECAUTIONS ——————————-

  • Bleeding: Serious and potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss.
  • Mechanical heart valves or moderate to severe mitral stenosis: Use is not recommended.

————————————ADVERSE REACTIONS —————————————-

  • Treatment of NVAF: The most common adverse reactions (≥ 5%) are bleeding and anemia.
  • Treatment of DVT and PE: The most common adverse reactions (≥ 1%) are bleeding, rash, abnormal liver function tests and anemia.

 

————————————– DRUG INTERACTIONS————————————–

  • Anticoagulants: Avoid concomitant use.
  • Rifampin: Avoid concomitant use.

————————————–USE IN SPECIFIC POPULATIONS ————————-

  • Nursing mothers: Discontinue drug or discontinue nursing.
  • Impaired renal function (CrCL 15 to 50 mL/min): Reduce dose.
  • Moderate or severe hepatic impairment: Not recommended.

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