Xarelto

DVT & pulmonary embolism (PE). Prevention of VTE in patients undergoing major orthopaedic surgery of the lower limbs; stroke & systemic embolism in patients w/ non-valvular atrial fibrillation; recurrent DVT & PE following acute DVT in adults.

Continued treatment & prevention of recurrent DVT & PE Recommended dose: Initially 15 mg bid for 1st 3 wk (Day 1-21) followed by 20 mg once daily (day 22 onwards). Max daily dose: 30 mg during 1st 3 wk of treatment & 20 mg in the following treatment phase. Prevention of recurrent DVT or PE 10 mg or 20 mg once daily following completion of at least 6 mth treatment for DVT or PE. Prevention of VTE in patients undergoing major orthopaedic surgery of the lower limbs 10 mg once daily for 5 wk (major hip surgery) or 2 wk (major knee surgery). Initial dose to be taken 6-10 hr after surgery provided that hemostasis has been established. Prevention of stroke & systemic embolism in patients w/ non-valvular atrial fibrillation Recommended dose: 20 mg once daily. Max daily dose: 20 mg. Moderate renal impairment w/ CrCl <50-30 mL/min Recommended dose: 15 mg once daily.

10-mg tab: May be taken with or without food.; 15- & 20-mg tab: Should be taken with food. For patients w/ difficulty swallowing, tab may be crushed & mixed w/ water/soft foods (eg, applesauce) immediately prior to administration. Crushed tab may be given via gastric tubes then flushed w/ water.

Hypersensitivity. Clinically significant active bleeding eg, intracranial & GI bleeding. Hepatic disease associated w/ coagulopathy leading to clinically relevant bleeding risk. Pregnancy & lactation.

Discontinue treatment at least 24 hr before any invasive procedure or surgical intervention. Not recommended for thromboprophylaxis in patients who recently undergone transcatheter aortic valve replacement; w/ history of thrombosis diagnosed w/ antiphospholipid syndrome & persistently triple +ve for lupus anticoagulant, anticardiolipin & anti-β-2-glycoprotein I Abs; receiving concomitant systemic azole-antimycotics (eg, ketoconazole) or HIV PIs (eg, ritonavir); w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy, as alternative to unfractionated heparin. False elevation of INR values when converting patients from vit K antagonists to Xarelto. May unmask underlying malignancy when bleeding during antithrombotic treatment. Risk for development of epidural or spinal hematoma resulting in long-term paralysis when neuraxial (epidural/spinal) anesth or spinal puncture is performed. Patients w/ other prosthetic heart valves or other valve procedures; 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 hemorrhage, intraspinal or intracerebral vascular abnormalities, recent brain, spinal or ophth surgery, bronchiectasis or history of pulmonary bleeding; malignant disease; non-valvular atrial fibrillation who undergo percutaneous coronary intervention w/ stent placement. Unexplained fall in Hb & BP. Consider prophylactic treatment in patients at risk of ulcerative GI disease. Monitor for signs & symptoms of neurological impairment eg, numbness or weakness of legs, bowel or bladder dysfunction. Delay treatment for 24 hr if traumatic puncture occurs. Concomitant use w/ drugs affecting hemostasis (eg, NSAIDs), platelet aggregation inhibitors, other antithrombotics or SSRIs & SNRIs. May affect ability to drive & use machines. Moderate & severe hepatic impairment. Patients w/ moderate renal impairment receiving co-medications leading to increased rivaroxaban plasma conc; CrCl <30-15 mL/min. Not recommended in severe renal impairment (CrCl <15 mL/min). Women of childbearing potential should use effective contraception. Childn & adolescents <18 yr.

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

Increased systemic exposure, AUC & C_max w/ strong CYP 3A4 & P-gp inhibitors eg, ketoconazole, ritonavir. Decreased mean AUC w/ strong CYP 3A4 & P-gp inducer eg, rifampicin. Decreased plasma conc w/ strong CYP 3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort. Additive effect on anti-factor Xa activity w/ enoxaparin. Increased bleeding times w/ clopidogrel. Increased prothrombin time/INR more than additively & additive effects on aPTT, inhibition of factor Xa activity & endogenous thrombin potential when converting patients from warfarin to Xarelto & vice versa. Increased risk of bleeding w/ SSRIs or SNRIs. Affected clotting parameter tests 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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