Xarelto

2.5 mg: Co-administered w/ ASA for the prevention of atherothrombotic events in adults w/ CAD or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. 10 mg: Prevention of VTE in adults undergoing elective hip or knee replacement surgery. 15 mg/20 mg: Prevention of stroke & systemic embolism in adults w/ non-valvular atrial fibrillation w/ ≥1 risk factors eg, CHF, HTN, age ≥75 yr, DM, prior stroke or transient ischaemic attack. Treatment of VTE & prevention of VTE recurrence in childn & adolescents <18 yr (15 mg: weighing 30-50 kg; 20 mg: weighing >50 kg) after at least 5 days of initial parenteral anticoagulation treatment. 10 mg/15 mg/20 mg: Treatment of DVT & pulmonary embolism (PE), & prevention of recurrent DVT & PE in adults.

Adult CAD/PAD 2.5 mg bd, co-administered w/ ASA 75-100 mg daily. Prevention of VTE in elective hip or knee replacement surgery 10 mg once daily. Take initial dose 6-10 hr after surgery, provided that haemostasis has been established. Duration of treatment: 5 wk (major hip surgery); 2 wk (major knee surgery). Treatment of DVT & PE, & prevention of recurrent DVT & PE 15 mg bd on days 1-21 for the initial treatment of acute DVT or PE, followed by 20 mg once daily on day 22 onwards for the continued treatment & prevention of recurrent DVT & PE. When extended prevention of recurrent DVT & PE is indicated, administer 10 mg or 20 mg once daily following completion of at least 6 mth therapy for DVT or PE. Prevention of stroke & systemic embolism Recommended & max dose: 20 mg once daily. Childn & adolescent <18 yr Treatment of VTE & prevention of VTE recurrence Initiate Xarelto treatment following at least 5 days of initial parenteral anticoagulation treatment. Recommended & max dose: 20 mg once daily (if weighing ≥50 kg); 15 mg once daily (if weighing 30-50 kg). Adult w/ moderate or severe renal impairment Treatment of DVT & PE, & prevention of recurrent DVT & PE 15 mg bd for the 1st 3 wk. Prevention of stroke & systemic embolism 15 mg once daily.

Crush & mix w/ water or apple puree immediately prior to use for patients who are unable to swallow whole tab. Crushed tab may be given through gastric tubes. 2.5 mg/10 mg: May be taken with or without food. 15 mg/20 mg: Should be taken with food: Administration of crushed tab should be immediately followed by food. In childn & adolescents, tab must not be split in an attempt to provide a fraction of a tab dose.

Hypersensitivity. Active clinically significant bleeding. Lesion or condition, if considered to be a significant risk for major bleeding, including current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, 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 treatment w/ any 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 patients w/ Child-Pugh B & C. Pregnancy & lactation. 2.5 mg: Concomitant treatment w/ ASA in CAD/PAD patients w/ previous haemorrhagic or lacunar stroke, or any stroke w/in a mth.

Haemorrhagic risk. Discontinue if severe haemorrhage occurs. Not recommended in patients w/ increased bleeding risk (eg, 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); patients w/ prosthetic heart valves; patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Weigh individual benefit of antithrombotic treatment against risk for bleeding in patients w/ active cancer dependent on tumour location, antineoplastic therapy & stage of disease. Should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement. Risk of spinal/epidural haematoma when spinal/epidural anaesth or puncture is employed in patients treated w/ antithrombotic agents for prevention of thromboembolic complications. Post-marketing reports of serious skin reactions, including SJS/TEN & DRESS. Discontinue at the 1st appearance of severe skin rash or any other sign of hypersensitivity in conjunction w/ mucosal lesions. Not recommended in patients receiving concomitant systemic treatment w/ strong CYP3A4 & P-gp inhibitors (eg, azole-antimycotics, HIV PIs). Caution in patients treated concomitantly w/ medicinal products affecting haemostasis (eg, NSAIDs, ASA, platelet aggregation inhibitors, SSRIs, SNRIs). Consider appropriate prophylactic treatment for patients at risk of ulcerative GI disease. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Not recommended in adults w/ CrCl <15 mL/min. Caution in adults w/ severe renal impairment (CrCl 15-29 mL/min); moderate renal impairment (CrCl 30-49 mL/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma conc. Not recommended in childn <18 yr. Increasing age may increase haemorrhagic risk. 2.5 mg: Avoid long-term dual antiplatelet therapy w/ ASA & clopidogrel in patients after recent revascularisation procedure of the lower limb due to symptomatic PAD. Treatment in combination w/ other antiplatelet agents (eg, prasugrel or ticagrelor) is not recommended. Caution in CAD/PAD patients ≥75 yr or w/ lower body wt (<60 kg) if co-administered w/ ASA alone or w/ ASA plus clopidogrel; CAD patients w/ severe symptomatic heart failure. Discontinue at least 12 hr before an invasive procedure or surgical intervention, then restart as soon as possible after if clinical situation allows & adequate haemostasis has been established. 10 mg: Has not been studied to evaluate efficacy & safety in patients undergoing hip fracture surgery. 15 mg/20 mg: Limited data in childn w/ cerebral vein & sinus thrombosis who have CNS infection, therefore carefully evaluate risk of bleeding before & during therapy w/ rivaroxaban. Not recommended in childn & adolescents w/ moderate or severe renal impairment (GFR <50 mL/min/1.73 m²). Limited data on efficacy in patients w/ non-valvular atrial fibrillation who undergo percutaneous coronary intervention w/ stent placement. 10 mg/15 mg/20 mg: Not recommended as 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: other than elective hip or knee replacement surgery), then restart as soon as possible after if clinical situation allows & adequate haemostasis has been established.

Anaemia; dizziness, headache; eye haemorrhage (including conjunctival haemorrhage); hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GIT haemorrhage (including rectal haemorrhage), GI & abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting; increased transaminases; pruritus, rash, ecchymosis, cutaneous & SC haemorrhage; pain in extremity; urogenital tract haemorrhage (including haematuria & menorrhagia), renal impairment (including increased blood creatinine & urea); fever, peripheral oedema, decreased general strength & energy (including fatigue & asthenia); post-procedural haemorrhage (including post-op anaemia, & wound haemorrhage), contusion, wound secretion.

Increased bleeding risk w/ strong CYP3A4 & P-gp inhibitors (eg, ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir); other anticoagulants; NSAIDs (including ASA), platelet aggregation inhibitors; SSRIs, SNRIs. Potentially significant interaction in high-risk patients w/ clarithromycin (strong CYP3A4 inhibitor & moderate P-gp inhibitor); erythromycin (moderate CYP3A4 & P-gp inhibitor); fluconazole (moderate CYP3A4 inhibitor). Avoid co-administration w/ dronedarone. Reduced plasma conc w/ strong CYP3A4 inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). Clotting parameters are affected as expected by the mode of action of rivaroxaban.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AF01 - rivaroxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.

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