Rivaroxaban

Chemical formula: C₁₉H₁₈ClN₃O₅S Molecular mass: 435.881 g/mol PubChem compound: 9875401

Therapeutic indications

Rivaroxaban is indicated for:

Primary prevention of venous thromboembolic events in total hip replacement surgery or total knee replacement surgery

Population group: only adults (18 years old or older)

Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

10 mg once daily

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF)

Population group: only adults (18 - 65 years old)

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

20 mg once daily

Deep vein thrombosis (DVT), pulmonary embolism (PE)

Population group: only adults (18 years old or older)

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)

For this indication, competent medicine agencies globally authorize below treatments (click for details):

30 mg in 2 divided doses daily for the first three weeks followed by 20 mg once daily

Prevention of atherothrombotic events after an acute coronary syndrome (ACS)

Population group: only adults (18 years old or older)

Rivaroxaban, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

5 mg in 2 divided doses daily

Prevention of atherothrombotic events in coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD)

Population group: only adults (18 years old or older)

Rivaroxaban, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

5 mg in 2 divided doses daily

Contraindications

Rivaroxaban is contraindicated in the following cases:

Pregnancy

Pregnancy

Lactation

Lactation

Active clinically significant bleeding

Bleeding

Hepatic impairment (Child Pugh B and C)

at least one of

Child-Pugh score class B
Child-Pugh score class C

Previous haemorrhagic or lacunar stroke, or any stroke within a month and ASA administration

CVA - Cerebrovascular accident and additionally Acetylsalicylic acid

Prior stroke or a transient ischaemic attack (TIA) with antiplatelet therapy

Platelet aggregation inhibitors excl. heparin and additionally at least one of

CVA - Cerebrovascular accident
Temporary cerebral vascular dysfunction

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