Rivacryst

Treatment of 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, age ≥75 yr, DM, prior stroke or transient ischaemic attack.

Treatment of DVT & PE, & prevention of recurrent DVT & PE 15 mg bd on days 1-21 for initial treatment of acute DVT or PE, followed by 20 mg once daily on day 22 onwards for continued treatment & prevention of recurrent DVT & PE. Patient w/ moderate (CrCl 30-49 mL/min) or severe (CrCl 15-29 mL/min) renal impairment 15 mg bd for the 1st 3 wk. Thereafter, when the recommended dose is 20 mg once daily, consider dose reduction from 20 mg to 15 mg once daily if patient's assessed risk for bleeding outweighs risk for recurrent DVT & PE. Extended prevention of recurrent DVT & PE 10 mg once daily following completion of at least 6 mth therapy for DVT or PE. Consider 20 mg once daily in patients w/ high risk of recurrent DVT or PE eg, complicated comorbidities or developed recurrent DVT or PE on extended prevention w/ 10 mg once daily. Prevention of VTE in elective hip or knee replacement surgery 10 mg once daily. Take initial dose 6-10 hr after surgery, provided that haemostasis has been established. Duration of treatment: 5 wk for major hip surgery; 2 wk for major knee surgery. Prevention of stroke & systemic embolism Recommended & max dose: 20 mg once daily. Patient w/ moderate (CrCl 30-49 mL/min) or severe (CrCl 15-29 mL/min) renal impairment 15 mg once daily.

May be crushed & mixed w/ water or apple puree immediately prior to use if unable to swallow whole tab. May also administer crushed tab through gastric tubes. 10 mg: May be taken with or without food. 15 mg & 20 mg: Should be taken with food: Administration of crushed tab should be immediately followed by 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/ any other anticoagulants eg, unfractionated heparin (UFH), LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran etexilate, apixaban) except under specific circumstances of 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.

Carefully observe for signs of bleeding. Discontinue administration if severe haemorrhage occurs. Patients w/ cancer whose tumours are located in the GIT or GUT have been associated w/ increased risk of bleeding during rivaroxaban therapy. Risk of developing epidural or spinal haematoma when spinal/epidural anaesth or puncture is employed in patients treated w/ antithrombotic agents. Stop dosing at least 24 hr before & restart as soon as possible after an invasive procedure or surgical intervention. Increasing age may increase haemorrhagic risk. Post-marketing reports of serious skin reactions, including SJS/TEN & DRESS. Discontinue treatment at the 1st appearance of severe skin rash (eg, spreading, intense &/or blistering), or any other sign of hypersensitivity in conjunction w/ mucosal lesions. Do not use for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement. Associated w/ increased rates of recurrent thrombotic events in patients who are triple +ve (for lupus anticoagulant, anticardiolipin Abs, & anti-β₂-glycoprotein I Abs). Not recommended in patients w/ prosthetic heart valves; history of thrombosis who are diagnosed w/ antiphospholipid syndrome; 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. Not recommended as alternative to UFH in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Not recommended if receiving concomitant systemic treatment w/ azole antimycotics (eg, ketoconazole, itraconazole, voriconazole, posaconazole) or HIV PIs (eg, ritonavir). Caution if concomitantly treated w/ medicinal products affecting haemostasis eg, NSAIDs, ASA, platelet aggregation inhibitors, SSRIs, SNRIs. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Caution in patients w/ renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma conc. Caution in patients w/ CrCl 15-29 mL/min. Not recommended in patients w/ CrCl <15 mL/min. Women of childbearing potential should avoid becoming pregnant during treatment. 10 mg: Has not been studied in interventional clinical studies in patients undergoing hip fracture surgery to evaluate efficacy & safety. Not recommended in childn <18 yr. 15 mg & 20 mg: Start treatment at least 4 hr before transesophageal echocardiogram guided cardioversion to ensure adequate anticoagulation in patients not previously treated w/ anticoagulants. Limited experience of a reduced dose of 15 mg once daily (or 10 mg once daily for patients w/ moderate renal impairment) in addition to a P2Y12 inhibitor for a max of 12 mth in patients w/ non-valvular atrial fibrillation who require oral anticoagulation & undergo percutaneous coronary intervention w/ stent placement.

Anaemia; dizziness, headache; eye haemorrhage; hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GIT haemorrhage, GI & abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting; increased transaminases; pruritus, rash, ecchymosis, cutaneous & SC haemorrhage; pain in extremity; urogenital tract haemorrhage, renal impairment; fever, peripheral oedema, decreased general strength & energy; postprocedural haemorrhage, contusion, wound secretion.

Increased plasma conc w/ strong inhibitors of CYP3A4 & P-gp eg, azole antimycotics (eg, ketoconazole, itraconazole, voriconazole, posaconazole) or HIV PIs (eg, ritonavir); clarithromycin (strong CYP3A4 inhibitor & moderate P-gp inhibitor); erythromycin (moderate inhibitor of CYP3A4 & P-gp); fluconazole (moderate CYP3A4 inhibitor). Avoid co-administration w/ dronedarone. Additive effect on anti-factor Xa activity w/ enoxaparin. Increased bleeding risk w/ other anticoagulants; NSAIDs (including ASA) & platelet aggregation inhibitors; SSRIs or SNRIs. Converting from warfarin to rivaroxaban or from rivaroxaban to warfarin increased prothrombin time/INR more than additively, whereas effects on aPTT, inhibition of factor Xa activity & endogenous thrombin potential were additive. Reduced plasma conc w/ strong CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort. Clotting parameters are affected as expected by the mode of action of rivaroxaban.

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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