Four Star
Concise Prescribing Info
2.5-mg tab: Prevention of atherothrombotic events in adult patients w/ CAD or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events, co-administered w/ acetylsalicylic acid (ASA). 10-mg tab: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. 15- & 20-mg tab: Prevention of stroke & systemic embolism in adult patients w/ non-valvular atrial fibrillation w/ ≥1 risk factors eg, CHF, HTN, age ≥75 yr, DM, prior stroke or transient ischaemic attack. 10-, 15-, 20-mg tab: Treatment of DVT & pulmonary embolism (PE), & prevention of recurrent DVT & PE in adults.
Dosage/Direction for Use
2.5-mg tab CAD/PAD 2.5 mg bd, co-administered w/ daily dose of 75-100 mg ASA. 10-mg tab Prevention of VTE Initially 10 mg once daily taken 6-10 hr after surgery, provided that haemostasis has been established. Duration: 5 wk in patients w/ major hip surgery; 2 wk in patients w/ major knee surgery. 15- & 20-mg tab Prevention of stroke & systemic embolism Recommended & max dose: 20 mg once daily. 10-, 15-, 20-mg tab Treatment of DVT & PE, & prevention of recurrent DVT & PE Days 1-21: 15 mg bd. Total daily dose: 30 mg. Days 22 onwards: 20 mg once daily. Total daily dose: 20 mg. Prevention of recurrent DVT & PE Following completion of at least 6 mth therapy: 10 or 20 mg once daily. Total daily dose: 10 or 20 mg.
2.5 & 10-mg tab: May be taken with or without food. 15 & 20-mg tab: Should be taken with food: For patients w/ swallowing difficulty, may crush/mix tab w/ water/apple puree. For patients w/ gastric tube, crush tab w/ small amount of water & flush gastric tube w/ water after. Immediately follow 15 & 20-mg doses w/ food/enteral feeding.
Hypersensitivity. Active clinically significant bleeding. Lesion or condition w/ significant risk for major bleeding (eg, current or recent GI ulceration; presence of malignant neoplasms; recent brain or spinal injury; recent brain, spinal or ophth surgery; recent intracranial haemorrhage; known or suspected oesophageal varices; arteriovenous malformations; vascular aneurysms or major intraspinal or intracerebral vascular abnormalities). Concomitant use w/ other anticoagulants eg, unfractionated heparin (UFH), LMWH (eg, enoxaparin, dalteparin), heparin derivatives (eg, fondaparinux), oral anticoagulants (eg, warfarin, dabigatran etexilate, apixaban) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk including cirrhotic Child-Pugh B & C patients. Pregnancy & lactation. 2.5-mg tab: Concomitant treatment of CAD/PAD w/ ASA in patients w/ previous haemorrhagic or lacunar stroke, or any stroke w/in a mth.
Special Precautions
Haemorrhagic risk. Discontinue if severe haemorrhage occurs. Not recommended in patients w/ congenital or acquired bleeding disorders; uncontrolled severe arterial HTN; other GI disease w/o active ulceration that can potentially lead to bleeding complications; vascular retinopathy; bronchiectasis or history of pulmonary bleeding. Not recommended in patients w/ prosthetic heart valves. Not recommended in patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Risk of developing epidural or spinal hematoma w/ spinal or epidural anaesth or puncture. Reports of serious skin reactions. Discontinue at the 1st appearance of a severe skin rash, or any other sign of hypersensitivity in conjunction w/ mucosal lesions. Affected clotting parameters (eg, PT, aPTT, HepTest). Not recommended in patients receiving concomitant treatment w/ strong CYP3A4 & P-gp inhibitors (eg, azole-antimycotics or HIV PIs). Use w/ caution in patients treated concomitantly w/ medicinal products affecting haemostasis eg, NSAIDs, ASA, platelet aggregation inhibitors, SSRIs, & SNRIs. In patients at risk of ulcerative GI disease, prophylactic treatment may be considered. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive or operate machinery. Not recommended in patients w/ CrCl <15 mL/min. Use w/ caution in patients w/ severe renal impairment (CrCl 15-29 mL/min) or moderate renal impairment (CrCl 30-49 mL/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma conc. Elderly. Not recommended in childn <18 yr. 2.5-mg tab: Not indicated in combination w/ dual antiplatelet therapy. Use w/ caution in CAD/PAD patients ≥75 yr; lower body wt (<60 kg); severe symptomatic heart failure. Previous haemorrhagic or lacunar stroke, or ischaemic, non-lacunar stroke w/in the previous mth. Discontinue at least 12 hr before an invasive procedure or surgical intervention; restart as soon as possible after. 10-mg tab: Hip fracture surgery. 15- & 20-mg tab: Patients w/ non-valvular atrial fibrillation who undergo percutaneous coronary intervention (PCI) w/ stent placement. 10-, 15-, 20-mg tab: Not recommended as an alternative to UFH in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Discontinue at least 24 hr before an invasive procedure or surgical intervention (10-mg tab: invasive procedure or surgical intervention other than elective hip or knee replacement therapy); restart as soon as possible after.
Adverse Reactions
Anemia; dizziness, headache; eye haemorrhage (including conjuctival haemorrhage); hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GI tract haemorrhage (including rectal haemorrhage), GI & abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting; increase in transaminases; pruritus, rash, ecchymosis, cutaneous & subcutaneous haemorrhage; pain in extremity; urogenital tract haemorrhage (including haematuria & menorrhagia), renal impairment (including increased blood creatinine, blood urea); fever, peripheral oedema, fatigue & asthenia; post-procedural haemorrhage (including post-op anaemia, & wound haemorrhage), contusion, wound secretion.
Drug Interactions
Increased risk of bleeding w/ strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole) or HIV PIs (eg, ritonavir); other anticoagulants; NSAIDs (eg, acetylsalicylic acid), platelet aggregation inhibitors; SSRIs/SNRIs. Avoid co-administration w/ dronedarone. Potential increased plasma conc w/ CYP3A4 or P-gp inhibitors, or moderate CYP3A4 & P-gp inhibitors especially in high-risk patients. Reduced plasma conc w/ strong CYP3A4 inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's Wort [Hypericum perforatum]).
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AF01 - rivaroxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
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