Rhea Rivaroxaban

Treatment of DVT & pulmonary embolism (PE), & prevention of recurrent DVT & PE. 10-mg tab: Prevention of VTE in adults undergoing elective hip or knee replacement surgery. 15- & 20-mg tab: Prevention of stroke & systemic embolism in patients w/ non-valvular atrial fibrillation (SPAF).

Treatment & prevention of recurrent DVT or PE Days 1-21: 15 mg bid. Total daily dose: 30 mg. Day 22 onwards: 20 mg once daily. Total daily dose: 20 mg. Prevention of recurrent DVT or PE Following completion of at least 6 mth treatment for DVT or PE: 10 mg or 20 mg once daily. Total daily dose: 10 mg or 20 mg. 10-mg tab VTE prevention in major orthopedic surgery 10 mg once daily, initially taken w/in 6-10 hr after surgery provided hemostasis has been established. Duration: 5 wk after major hip surgery or 2 wk after major knee surgery. 15- & 20-mg tab SPAF 20 mg once daily. Max daily dose: 20 mg. Patient w/ moderate renal impairment (CrCl 30-<50 mL/min) 15 mg once daily. Patient w/ non-valvular atrial fibrillation who undergoes percutaneous coronary intervention (PCI) w/ stent placement 15 mg once daily (or 10 mg once daily for patient w/ moderate renal impairment) in addition to P2Y12 inhibitor for max of 12 mth after PCI w/ stent placement.

Tab may be crushed & mixed w/ water or soft foods (eg, applesauce) immediately prior to use in patient unable to swallow whole tab. The crushed tab may also be administered in small amount of water via gastric tube then flushed w/ water. 10-mg tab: May be taken with or without food. 15- & 20-mg tab: Should be taken with food. After administration of crushed 15- or 20-mg tab, the dose should then be immediately followed by enteral feeding.

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

Not recommended for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement; in patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome & are persistently triple +ve (for lupus anticoagulant, anticardiolipin Abs & anti-β₂-glycoprotein I Abs); as alternative to unfractionated heparin in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Safety & efficacy have not been studied in patients w/ other prosthetic heart valves or other valve procedures. Caution in patients w/ 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. Risk for development of epidural or spinal hematoma when neuraxial (epidural/spinal) anesth or spinal puncture is performed in patients treated for prevention of thromboembolic complications. Discontinue use at least 24 hr prior to invasive procedure or surgical intervention. Not recommended in patients receiving concomitant systemic treatment w/ azole-antimycotics (eg, ketoconazole) or HIV PIs (eg, ritonavir). Concomitant use w/ drugs affecting hemostasis eg, NSAIDs, platelet aggregation inhibitors, other antithrombotics, or SSRI, & SNRIs. Not to be taken by patients w/ lactose or galactose intolerance eg, Lapp lactase deficiency or glucose-galactose malabsorption. Caution in patients w/ severe (15-<30 mL/min) renal impairment. Not recommended in patients w/ CrCl <15 mL/min. Do not drive or use machines if syncope & dizziness are experienced. Use only w/ effective contraception in women of childbearing potential. Safety & efficacy have not been established in childn & adolescents <18 yr. 10-mg tab: Has not been studied in patients undergoing hip fracture surgery. Caution in patients w/ moderate (CrCl 30-<50 mL/min) renal impairment receiving co-medications leading to increased rivaroxaban plasma conc. 15- & 20-mg tab: Limited data on efficacy in patients w/ non-valvular atrial fibrillation who undergo PCI w/ stent placement.

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); postprocedural hemorrhage (including post-op anemia & wound hemorrhage), contusion; increase in 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.

May lead to both reduced hepatic & renal clearance & thus significantly increased systemic exposure w/ strong CYP3A4 & P-gp inhibitors. Increased mean AUC & C_max w/ significant increases in pharmacodynamic effects w/ ketoconazole & ritonavir (strong CYP3A4 & P-gp inhibitor). Increased mean AUC & C_max w/ clarithromycin (strong CYP3A4 & moderate P-gp inhibitor); erythromycin (moderate CYP3A4 & P-gp inhibitor); fluconazole (moderate CYP3A4 inhibitor); other active substances that are either strong CYP3A4 or strong P-gp inhibitor. Decreased mean AUC w/ parallel decreases in pharmacodynamic effects w/ rifampicin (strong CYP3A4 & P-gp inducer). Plasma conc may be decreased w/ other strong CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort. Additive effect on anti-factor Xa activity w/ enoxaparin w/o any additional effects on clotting tests (PT, aPTT). Relevant increase in 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 rivaroxaban or vice versa. Increased risk of bleeding w/ SSRIs or SNRIs. May affect 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.

Rx