Floriva

DVT & pulmonary embolism (PE). Prevention of recurrent DVT & PE in adults. 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, ≥75 yr, DM, prior stroke or transient ischaemic attack. VTE & prevention of VTE recurrence in childn & adolescents <18 yr weighing 30-50 kg (for 15 mg) or >50 kg (for 20 mg) after at least 5 days of initial parenteral anticoagulation treatment.

Prevention of VTE in adults undergoing elective hip or knee replacement surgery 10 mg once daily. Initial dose taken 6-10 hr post-op once haemostasis has been established. Treatment duration: 5 wk in patients undergoing major hip surgery, 2 wk in patients undergoing major knee surgery. Prevention of stroke & systemic embolism Adult Recommended & max dose: 20 mg once daily. Moderate (CrCl 30-49 mL/min) or severe (CrCl 15-29 mL/min) renal impairment 15 mg once daily. DVT, PE & prevention of recurrent DVT & PE Adult Initially 15 mg bid for 1st 3 wk, followed by 20 mg once daily. Treatment duration: At least 3 mth in patients w/ DVT or PE provoked by major transient risk factors (eg, recent major surgery or trauma), longer duration in patients w/ provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or history of recurrent DVT or PE. Moderate (CrCl 30-49 mL/min) or severe (CrCl 15-29 mL/min) renal impairment 15 mg bid for 1st 3 wk, then 15 mg once daily if patient's risk for bleeding outweighs risk for recurrent DVT & PE. Extended prevention of recurrent DVT & PE (following completion of at least 6 mth therapy) 10 mg once daily. Patients in whom risk of recurrent DVT or PE is considered high 20 mg once daily. VTE & prevention of VTE recurrence Childn & adolescent <18 yr weighing ≥50 kg Recommended & max dose: 20 mg once daily initiated following at least 5 days of initial parenteral anticoagulant, 30-50 kg Recommended & max dose: 15 mg once daily initiated following at least 5 days of initial parenteral anticoagulant. Treatment duration: 3-12 mth. Converting from vit K antagonists (VKA) to rivaroxaban Stop VKA & initiate rivaroxaban therapy when INR is ≤3 in prevention of stroke & systemic embolism, or ≤2.5 in DVT, PE & prevention of recurrence in adults & VTE & prevention of recurrence in paed. Converting from rivaroxaban to VKA Give VKA concurrently until INR is ≥2. Childn Continue rivaroxaban for 48 hr after 1st dose of VKA until INR is ≥2. Converting from parenteral anticoagulant to rivaroxaban Discontinue parenteral anticoagulant & start rivaroxaban 0-2 hr before the next scheduled administration of parenteral medicinal product is due or discontinued. Converting from rivaroxaban to parenteral anticoagulant Give 1st dose of parenteral anticoagulant at the next rivaroxaban dose. Transesophageal echocardiogram guided cardioversion in patients not previously treated w/ anticoagulants Start treatment at least 4 hr before cardioversion.

May crush & dissolve tab & administer orally or via gastric tubes. 10 mg: May be taken with or without food: 15 mg & 20 mg: Should be taken with food: Immediately follow w/ food.

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/ other anticoagulants eg, unfractionated heparin, LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran etexilate, apixaban) except when 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.

Serious skin reactions including SJS/TEN & DRESS. Discontinue treatment at 1st appearance of severe skin rash (spreading, intense &/or blistering) or any other sign of hypersensitivity in conjunction w/ mucosal lesions; if severe haemorrhage occurs; at least 24 hr before invasive procedure or surgical intervention & restart as soon as possible after the procedure. Not to be used for thromboprophylaxis in patients who recently undergone transcatheter aortic valve replacement; as alternative to unfractionated heparin in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. 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 who are diagnosed w/ antiphospholipid syndrome; history of stroke/transient ischaemic attack; CrCl <15 mL/min. Mucosal bleedings (eg, epistaxis, gingival, GI, genitourinary including abnormal vag or increased menstrual bleeding) & anaemia. Risk of developing epidural or spinal haematoma when neuraxial anaesth (spinal/epidural anaesth) or spinal/epidural puncture is employed. Perform clinical surveillance throughout treatment period; lab testing of Hb/haematocrit. Patients w/ active cancer; undergoing hip fracture surgery; w/ CrCl 15-29 mL/min. Observe patients for signs of bleeding. Search for bleeding site if patient experiences any unexplained fall in Hb or BP. Measure rivaroxaban levels w/ calibrated quantitative anti-factor Xa assay during treatment. Monitor for signs & symptoms of neurological impairment eg, numbness or weakness of legs, bowel or bladder dysfunction. Avoid co-administration w/ dronedarone. Not recommended to take concomitantly w/ systemic azole-antimycotics eg, ketoconazole, itraconazole, voriconazole & posaconazole; HIV PIs eg, ritonavir. Concomitant use w/ medicinal products affecting homeostasis eg, NSAIDs, ASA, platelet aggregation inhibitors or SSRIs, SNRIs. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on ability to drive & use machines. Not recommended in childn & adolescents w/ moderate or severe renal impairment (GFR <50 mL/min/1.73 m²). Increased plasma levels in adults w/ severe renal impairment (CrCl <30 mL/min). Women of child bearing potential should avoid becoming pregnant during treatment. Not recommended in childn <18 yr in DVT, PE & prevention of stroke & systemic embolism. Childn w/ cerebral vein & sinus thrombosis who have CNS infection; evaluate risk of bleeding before & during therapy. Increased haemorrhagic risk in the elderly.

Anaemia; dizziness, headache; eye haemorrhage including conjunctival haemorrhage; hypotension, haematoma, epistaxis, haemoptysis; gingival bleeding, GIT (including rectal) haemorrhage, GI & abdominal pain, dyspepsia, nausea, constipation, diarrhoea, vomiting; increased transaminases; pruritus (including generalised 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; postprocedural haemorrhage (including post-op anaemia & wound haemorrhage), contusion, wound secretion. SJS/TEN, DRESS.

Increased mean AUC & C_max w/ ketoconazole; clarithromycin; erythromycin; fluconazole. Additive effect on anti-factor Xa activity w/ enoxaparin. Increased bleeding time w/ clopidogrel. Increased bleeding risk w/ NSAIDs, platelet aggregation inhibitors; SSRIs, SNRIs. Increased prothrombin time, additive effects on aPTT, inhibition of factor Xa activity & endogenous thrombin potential. Decreased mean AUC w/ rifampicin. Reduced plasma conc w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort (Hypericum perforatum). Affected 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.

D