Rivarox-20

DVT & pulmonary embolism (PE). Prevention of stroke & systemic embolism in patients w/ non-valvular atrial fibrillation; recurrent DVT & PE, & those following acute DVT in adults.

DVT & PE Initially 15 mg bid for 1st 3 wk (max: 30 mg daily) followed by 20 mg once daily (max: 20 mg daily) for continued treatment & prevention of recurrent DVT & PE. Stroke prevention in atrial fibrillation Recommended & max dose: 20 mg once daily. Moderate renal impairment 15 mg once daily. Transesophageal echocardiogram guided cardioversion in patients not previously treated w/ anticoagulants Start treatment at least 4 hr before cardioversion. Patient w/ non-valvular atrial fibrillation who undergo percutaneous coronary intervention (PCI) w/ stent placement Reduce dose to 15 mg once daily [or 10 mg once daily for patients w/ moderate renal impairment (CrCl <50-30 mL/min)] in addition to P2Y12 inhibitor. Max duration: 12 mth after PCI w/ stent placement. Conversion from parenteral anticoagulants to rivaroxaban Start treatment 0-2 hr before the time of next scheduled administration of parenteral drug (eg, LMWH) or at the time of discontinuation of continuously administered parenteral drug (eg, IV unfractionated heparin). Conversion from rivaroxaban to parenteral anticoagulants Give 1st dose of parenteral anticoagulant at the time the next rivaroxaban dose would be taken.

Should be taken with food.

Hypersensitivity. Patients w/ clinically significant active bleeding (eg, intracranial & GI bleeding); hepatic disease associated w/ coagulopathy leading to clinically relevant bleeding risk. Pregnancy & lactation.

Not recommended in patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome & are persistently triple +ve (for lupus anticoagulant, anticardiolipin Abs, & anti-β 2-glycoprotein I Abs); as alternative to unfractionated heparin in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Not to w/draw epidural catheter earlier than 18 hr in young adults & 26 hr in elderly patients after last administration. Stop treatment at least 24 hr before intervention if invasive procedure or surgical intervention is required. Risk for development of epidural or spinal hematoma resulting in long-term paralysis when neuraxial (epidural/spinal) anesth or spinal puncture is performed in patients treated w/ antithrombotic for prevention of thromboembolic complications; further risk by use of indwelling epidural catheters or concomitant use of drugs affecting haemostasis, & traumatic or repeated epidural or spinal puncture. Patients w/ prosthetic heart valves; increased bleeding risk eg, congenital or acquired bleeding disorders; uncontrolled severe arterial HTN; active ulcerative GI disease; recent GI ulcerations; vascular retinopathy; recent intracranial or intracerebral haemorrhage; intraspinal or intracerebral vascular abnormalities; recent brain, spinal or ophthalmological surgery; bronchiectasis or history of pulmonary bleeding. Any unexplained fall in Hb or BP should lead to search for bleeding site. Delay administration for 24 hr if traumatic puncture occurs. Carefully monitor for signs of bleeding complications after treatment initiation. Frequently monitor for signs & symptoms of neurological impairment (eg, numbness or weakness of legs, bowel or bladder dysfunction). Administer at earliest 6 hr after removal of catheter. Consider appropriate prophylactic treatment for patients at risk of ulcerative GI disease. Assess increased risk of bleeding against urgency of intervention if procedure cannot be delayed. Not recommended in patients receiving concomitant systemic treatment w/ strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole) or HIV PIs (eg, ritonavir). Concomitant treatment w/ drugs affecting haemostasis eg, NSAIDs, platelet aggregation inhibitors, or other antithrombotics, SSRIs, & SNRIs. May affect ability to drive or use machines due to syncope & dizziness. Moderate & severe hepatic impairment. Not recommended in severe renal impairment & CrCl <15 mL/min. Patients w/ moderate renal impairment receiving co-medications leading to increased rivaroxaban plasma conc; CrCl <30-15 mL/min. Women of childbearing potential should only use effective contraception. Childn & adolescents <18 yr.

Anemia (including respective lab parameters); eye haemorrhage (including conjunctival haemorrhage); gingival bleeding, GIT haemorrhage (including rectal haemorrhage), GI & abdominal pains, dyspepsia, nausea, constipation, diarrhea, vomiting; fever, peripheral edema, decreased general strength & energy (including fatigue & asthenia); post procedural haemorrhage (including post-op anemia & wound haemorrhage), contusion; increased transaminases; pain in extremity; dizziness, headache; urogenital tract haemorrhage (including haematuria & menorrhagia), renal impairment (including increased blood creatinine & urea); epistaxis, hemoptysis; pruritus (including uncommon cases of generalized pruritus), rash, ecchymosis, cutaneous & SC haemorrhage; hypotension, hematoma.

Reduced hepatic & renal clearance, & increased systemic exposure w/ strong CYP 3A4 & P-gp inhibitors. Increased mean steady state AUC & C_max w/ significant increase in pharmacodynamic effects w/ azole-antimycotic (ketoconazole); HIV PI (ritonavir). Decreased mean AUC w/ parallel decrease in pharmacodynamic effects w/ strong CYP 3A4 & P-gp inducer (rifampicin). Decreased plasma conc w/ other strong CYP 3A4 inducers (eg, phenytoin, carbamazepine, phenobarb or St. John's wort). Additive effect on anti-factor Xa activity w/ enoxaparin. Increased bleeding time w/ clopidogrel. Increased risk of bleeding w/ SSRIs or SNRIs. Additive effects on aPTT, factor Xa activity inhibition & endogenous thrombin potential & increased prothrombin time/INR w/ conversion from warfarin to rivaroxaban or vice versa. Concomitant use w/ clotting parameter tests (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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