Difference between revisions of "Edoxaban (Savaysa)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
*2015-01-08: Approved for the treatment of [[Venous thromboembolism|deep vein thrombosis (DVT) and pulmonary embolism (PE)]] following 5-10 days of initial therapy with a parenteral anticoagulant. ''(Based on Hokusai VTE and Hokusai VTE Cancer)''
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*2015-01-08: Approved for the treatment of [[Venous thromboembolism|deep vein thrombosis (DVT) and pulmonary embolism (PE)]] following 5-10 days of initial therapy with a parenteral anticoagulant. ''(Based on Hokusai-VTE and Hokusai VTE Cancer)''
 
*2015-01-08: Approved to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). ''(Non-hematologic indication)''
 
*2015-01-08: Approved to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). ''(Non-hematologic indication)''
 
==History of changes in PMDA indication==
 
==History of changes in PMDA indication==

Revision as of 14:02, 23 July 2023

General information

Class/mechanism: Factor Xa inhibitor, acts at the active site of factor Xa to inhibit its actions in the coagulation cascade.[1][2][3]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Patient drug information

History of changes in FDA indication

  • 2015-01-08: Approved for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant. (Based on Hokusai-VTE and Hokusai VTE Cancer)
  • 2015-01-08: Approved to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). (Non-hematologic indication)

History of changes in PMDA indication

  • 2014-09-26: New additional indications and new dosages, and a drug with a newly-added dosage form indicated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation, or for the treatment and prevention of the recurrence of venous thromboembolism (deep vein thrombosis and pulmonary thromboembolism).

Also known as

  • Code name: DU-176b
  • Brand name: Lixiana, Roteas, Savaysa

References