Roxavan

DVT, pulmonary embolism (PE) & prevention of recurrent DVT & PE in adults. 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 recurrent VTE in childn & adolescents <18 yr & >50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Adult Prevention of stroke & systemic embolism 20 mg once daily. DVT & PE & prevention of recurrent DVT & PE Initially 15 mg bid for 1st 3 wk followed by 20 mg once daily for continued treatment & prevention of 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. Patient w/ high risk of recurrent DVT or PE 20 mg once daily. Treatment & prevention of VTE Childn & adolescent <18 yr weighing ≥50 kg 20 mg once daily, 30-50 kg 15 mg once daily. Both are initiated following at least 5 days of initial parenteral anticoagulation treatment & continue for at least 3 mth & may be extended up to 12 mth. Severe (CrCl 15-29 mL/min) or moderate (CrCl 30-49 mL/min) renal impairment Prevention of stroke & systemic embolism w/ non-valvular atrial fibrillation 15 mg once daily. DVT & PE & prevention of recurrent DVT & PE 15 mg bid for 1st 3 wk.

Should be taken with food: For patients unable to swallow whole, may be crushed & mixed w/ water/apple puree immediately prior to use. Crushed tab may be given via nasogastric or gastric feeding tube.

Hypersensitivity. Active clinically significant bleeding; lesion or condition at significant risk for major bleeding eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain/spinal/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 except under specific circumstances of switching anticoagulant therapy or when unfractionated heparin (UFH) is given at doses necessary to maintain an open central venous or arterial catheter. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk including cirrhotic patients w/ Child-Pugh B & C. Pregnancy & breast-feeding.

Discontinue use if severe haemorrhage occurs; at 1st appearance of severe skin rash (eg, spreading, intense &/or blistering), or any other sign of hypersensitivity w/ mucosal lesions. Stop treatment at least 24 hr prior to invasive procedure or surgical interventions. Not recommended in patients w/ prosthetic heart valves; history of thrombosis diagnosed w/ antiphospholipid syndrome. Not an alternative to UFH in PE patients who are haemodynamically unstable or receiving thrombolysis or pulmonary embolectomy. Clinical surveillance throughout the treatment period. Consider lab testing of Hb/haematocrit. Serious skin reactions eg, SJS/TEN & DRESS. Congenital or acquired bleeding disorders, uncontrolled severe arterial HTN; other GI disease w/o active ulceration potentially leading to bleeding complications eg, IBD, oesophagitis & GERD; vascular retinopathy; bronchiectasis or history of pulmonary bleeding. Patients w/ active cancer; spinal/epidural anesth or puncture; non-valvular atrial fibrillation undergoing percutaneous coronary intervention w/ stent placement; undergoing cardioversion. Not recommended in concomitant use w/ azole-antimycotics eg, ketoconazole, itraconazole, voriconazole & posaconazole or HIV PIs eg, ritonavir. Concomitant use w/ NSAIDs, ASA & platelet aggregation inhibitors or SSRIs, SNRIs. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Has minor influence on the ability to drive & use machines. Not recommended in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk including cirrhotic patients w/ Child Pugh B & CrCl <15 mL/min. Severe renal impairment. Women of childbearing potential should avoid pregnancy during treatment. Not recommended in childn <18 yr. Elderly.

Anaemia; dizziness, headache; eye haemorrhage including conjunctival haemorrhage; hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GIT haemorrhage including rectal haemorrhage; GI & abdominal pain, dyspepsia, nausea, constipation, diarrhoea, vomiting; increased intransaminases; pruritus including uncommon cases of generalized 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.

Increased AUC & bleeding risk w/ CYP3A4 & P-gp inhibitors (azole antimycotics eg, ketoconazole, itraconazole, voriconazole, posaconazole or HIV PIs. Increased bleeding risk w/ other anticoagulants; NSAIDs & platelet aggregation inhibitors; SSRIs/SNRIs. Reduced plasma conc w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort (Hypericum perforatum). Avoid co-administration w/ dronedarone. 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.

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