Vebroz

DVT & pulmonary embolism (PE). Prevention of recurrent DVT & PE in adults. 10 mg: Prevention of VTE in patients undergoing major orthopedic lower limb surgery. 15 & 20 mg: Prevention of recurrent DVT & PE following acute DVT in adults; stroke & systemic embolism in patients w/ non-valvular atrial fibrillation (SPAF).

Treatment & prevention of recurrent DVT & PE Recommended dose: Initially 15 mg bid for the 1st 3 wk (day 1-21) followed by 20 mg once daily on day 22 onwards. 10 mg: Treatment duration: Continue as long as VTE risk persists. 15 mg & 20 mg: Max daily dose: 30 mg during 1st 3 wk, 20 mg in the following treatment phase. Prevention of recurrent DVT & PE Following treatment completion of at least 6 mth, 10 mg or 20 mg once daily. Conversion from rivaroxaban to vit K antagonists (VKA) Give VKA concurrently until INR is ≥2. Use standard VKA dosing for the 1st 2 days of conversion period followed by VKA dosing guided by INR testing. Conversion from parenteral anti-coagulants to rivaroxaban Start rivaroxaban 0-2 hr before next scheduled administration of parenteral drug or at time of discontinuation of continuously administered parenteral drug. 10 mg VTE prevention Recommended dose: 1 tab once daily w/ initial dose taken 6-10 hr after surgery. Treatment duration: 5 wk after major hip surgery; 2 wk after major knee surgery. 15 mg & 20 mg SPAF Recommended & max dose: 20 mg once daily. Moderate renal impairment (CrCl <50-30 mL/min) 15 mg once daily. Transesophageal echocardiogram guided cardioversion in patients not previously treated w/ anticoagulants Start rivaroxaban treatment at least 4 hr before cardioversion. Patient who undergoes percutaneous coronary intervention (PCI) w/ stent placement 15 mg once daily or 10 mg once daily for patients w/ moderate renal impairment (CrCl <50-30 mL/min) + P2Y12 inhibitor for max of 12 mth after PCI stent placement. Increase rivaroxaban dose to standard dose after completion of anti-platelet therapy.

10 mg: May be taken with or without food.; 15 mg & 20 mg: Should be taken with food: May crush & dissolve tab, & administer mixt orally or via gastric tubes. Take immediately.

Hypersensitivity. Active clinically significant bleeding. Lesion or condition considered to be significant risk for major bleeding eg, 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 (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran etexilate, apixaban) except under switching anticoagulant therapy or when UFH is given at doses necessary to maintain 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.

Discontinue treatment at 1st appearance of severe skin rash (eg, spreading, intense &/or blistering) or any sign of hypersensitivity in conjunction w/ mucosal lesions; if severe haemorrhage occurs; at least 24 hr before intervention if invasive procedure or surgical intervention is required. Not to be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement. 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 (eg, inflammatory bowel disease, oesophagitis, gastritis & GERD), vascular retinopathy, bronchiectasis or history of pulmonary bleeding; prosthetic heart valves; history of thrombosis diagnosed w/ antiphospholipid syndrome, particularly those that are triple +ve for lupus anticoagulant, anticardiolipin & anti-β2-glycoprotein I Ab; as alternative to unfractionated heparin in those w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Delay treatment for 24 hr if traumatic puncture occurs. SJS, TEN & DRESS. Unexplained fall in Hb or BP. Mucosal bleedings (eg, epistaxis, gingival, GI, genitourinary including abnormal vag or increased menstrual bleeding) & anaemia during long term treatment. Higher risk of bleeding & thrombosis in patients w/ malignant disease. Risk of developing epidural or spinal haematoma when spinal/epidural anaesth or puncture is employed. Patients w/ active cancer. Perform lab testing of Hb/haematocrit to detect occult bleeding & quantify relevance of overt bleeding. Monitor patients for signs & symptoms of bleeding complications & anaemia after treatment initiation; neurological impairment (eg, numbness or weakness of legs, bowel or bladder dysfunction). Closely observe surgical wound drainage & periodically measure Hb in patients receiving treatment for VTE prevention following elective hip or knee replacement surgery. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ medicinal products which can increase rivaroxaban plasma conc in patients w/ moderate renal impairment (CrCl 30-49 mL/min); NSAIDs, ASA & platelet aggregation inhibitors or SSRIs & SNRIs. Not recommended to use concomitantly w/ azole antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole) or HIV PIs (eg, ritonavir). Minor influence on ability to drive & use machines. Not recommended in patients w/ CrCl <15 mL/min. Severe renal impairment (CrCl 15-29 mL/min). Moderate or severe hepatic impairment. Women of childbearing potential should avoid becoming pregnant during treatment. Childn & adolescents <18 yr. Elderly. 10 mg: Patients undergoing hip fracture surgery. 15 & 20 mg: Patients w/ non-valvular atrial fibrillation who undergo PCI w/ stent placement & history of stroke/transient ischaemic attack. Discontinue treatment in childn on neuraxial catheter. Childn w/ cerebral vein & sinus thrombosis who have CNS infection; receiving concomitant systemic treatment w/ strong CYP3A4 & P-gp inhibitors. Not recommended in childn & adolescents w/ moderate or severe renal impairment (GFR <50 mL min/1.72 m²).

Anaemia; dizziness, headache; eye haemorrhage including conjunctival haemorrhage; hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GI tract 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. SJS/TEN, DRESS.

Increased AUC & C_max w/ CYP3A4 and P-gp inhibitors eg, azole antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole); HIV PIs; clarythromycin; erythromycin; fluconazole. Avoid concomitant use w/ dronedarone. Additive effects on anti-factor Xa activity w/ enoxaparin. Increased bleeding time w/ clopidogrel. Increased risk of bleeding w/ NSAIDs including ASA & platelet aggregation inhibitors; SSRIs or SNRIs. Increased prothrombin time/INR w/ warfarin. Decreased AUC w/ strong CYP3A4 inducer rifampicin. Decreased plasma conc w/ CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb, St. John's wort (Hypericum perforatum). May affect clotting parameters (eg, PT, aPTT, HepTest).

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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