Oral Prophylaxis of postoperative venous thromboembolism
Adult: 10 mg once daily. Dose is started 6-10 hours after surgery. Treatment duration: 2 weeks (major knee surgery); 5 weeks (major hip surgery).
Oral Prophylaxis of stroke in non-valvular atrial fibrillation, Prophylaxis of systemic embolism in non-valvular atrial fibrillation
Adult: 20 mg once daily with evening meal.
Oral Deep vein thrombosis, Pulmonary embolism
Adult: Treatment: Initially, 15 mg bid for 3 weeks. Maintenance: 20 mg once daily. Prevention of recurrence: 10 mg once daily, following completion of at least 6 months of anticoagulant therapy. May consider 20 mg daily in patients at high risk of recurrence.
Oral Prevention of atherothrombotic events
Adult: In cases following an acute coronary syndrome: 2.5 mg bid in combination with aspirin alone, or aspirin plus clopidogrel or ticlopidine.
What are the brands available for Rivaroxaban in Malaysia?
15 mg bid for 3 weeks. If the usual adult dose is 20 mg once daily, reduce dose to 15 mg once daily.
Prophylaxis of postoperative venous thromboembolism:
CrCl (mL/min)
Dosage
<15
Not recommended.
Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation:
CrCl (mL/min)
Dosage
<15
Not recommended.
15-49
15 mg once daily.
Prevention of atherothrombotic events following an acute coronary syndrome:
CrCl (mL/min)
Dosage
<15
Not recommended.
15-49
15 mg once daily with evening meal.
Hepatic Impairment
Moderate to severe hepatic impairment (Child-Pugh class B and C): Contraindicated.
Administration
Rivaroxaban 10-mg tab: May be taken with or without food. Rivaroxaban 15- & 20-mg tab: Should be taken with food.
Contraindications
Active pathologic bleeding; lesion or condition at risk for major bleeding (e.g. current or previous gastrointestinal ulceration, recent brain or spinal injury or surgery, recent ophthalmic surgery, presence of malignant neoplasms, known or suspected oesophageal varices), major intraspinal or intracerebral vascular abnormalities, arteriovenous malformations, vascular aneurysms. Hepatic disease associated with coagulopathy or those with moderate to severe hepatic impairment (Child-Pugh class B and C). Pregnancy and lactation. Concomitant use with strong CYP3A4 and P-glycoprotein (P-gp) inhibitors (e.g. cobicistat, ketoconazole, itraconazole, posaconazole, ritonavir); LMWH (e.g. enoxaparin, dalteparin); heparin derivatives (e.g. fondaparinux); other anticoagulants (e.g. unfractionated heparin), oral anticoagulants (e.g. warfarin, dabigatran, apixaban).
Special Precautions
Patient with conditions at increased risk of bleeding (e.g. uncontrolled severe hypertension, congenital or acquired bleeding disorders, vascular retinopathy, bronchiectasis, or history of pulmonary bleeding). Not recommended for use in patients with history of thrombosis who are diagnosed with antiphospholipid syndrome, particularly those who are triple-positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies) due to increased risk of recurrent thrombotic events compared with vitamin K antagonists. Renal impairment. Children and elderly.
Adverse Reactions
Significant: Mucosal bleeding (e.g. epistaxis, gastrointestinal, gingival, genitourinary including increased menstrual bleeding), anaemia (long term use); headache, fever, dizziness, paleness, unexplained swelling, increased risk of recurrent thrombotic events (particularly in patients with antiphospholipid syndrome and history of thrombosis). Cardiac disorders: Tachycardia, syncope. Eye disorders: Conjunctival haemorrhage. Gastrointestinal disorders: Nausea, abdominal pain, vomiting, dyspepsia. General disorders and administration site conditions: Fatigue, asthenia. Immune system disorders: Hypersensitivity reactions (e.g. anaphylactic shock, angioedema, pruritus, rash). Injury, poisoning and procedural complications: Wound haemorrhage, contusion. Investigations: Increase in serum transaminases. Musculoskeletal and connective tissue disorders: Pain in extremity. Renal and urinary disorders: Renal impairment. Vascular disorders: Hypotension, haematoma. Potentially Fatal: Major haemorrhage, haemorrhagic anaemia.
Patient Counseling Information
This drug may cause dizziness, somnolence, or vertigo, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor CBC, LFTs, and kidney function before initiation of treatment, when clinically indicated, and annually thereafter. Monitor for signs and symptoms of bleeding. Monitor signs and symptoms of neurologic impairment during neuraxial anaesthesia.
Overdosage
Symptoms: Haemorrhagic complications.
Management: Symptomatic and supportive treatment. May administer activated charcoal to decrease rivaroxaban absorption.
Drug Interactions
Increased risk of bleeding with NSAIDs (e.g. aspirin), antiplatelets (e.g. clopidogrel), SSRIs, and SNRIs. Decreased serum concentration with strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital). Potentially Fatal: Increased serum concentration and increased risk of bleeding with strong CYP3A4 and P-glycoprotein (P-gp) inhibitors (e.g. cobicistat, ketoconazole, itraconazole, posaconazole, ritonavir); LMWH (e.g. enoxaparin, dalteparin); heparin derivatives (e.g. fondaparinux); other anticoagulants (e.g. unfractionated heparin), oral anticoagulants (e.g. warfarin, dabigatran, apixaban).
Food Interaction
Decreased serum concentration with St. John’s wort.
Lab Interference
May prolong aPTT, HepTest, and Rusell viper venom time.
Action
Description: Mechanism of Action: Rivaroxaban is an anticoagulant which directly and selectively inhibits factor Xa, both intrinsic and extrinsic pathway of the blood coagulation cascade, thereby inhibiting the conversion of prothrombin to thrombin and development of thrombi. Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: Approx 80-100% (2.5 mg and 10 mg dose); approx 66% (20 mg dose). Time to peak plasma concentration: 2-4 hours. Distribution: Crosses placenta, enter breastmilk. Plasma protein binding: Approx 92-95%. Metabolism: Metabolised in the liver by CYP3A4/5 and CYP2J2 enzymes. Excretion: Via urine (66%; approx 36% as unchanged drug, 30% as inactive metabolites); faeces (28%; 7% as unchanged drug, 21% as inactive metabolites). Terminal elimination half-life: 7-11 hours.
Chemical Structure
Rivaroxaban Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9875401, Rivaroxaban. https://pubchem.ncbi.nlm.nih.gov/compound/Rivaroxaban. Accessed Feb. 22, 2024.
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