Xarelto

Xarelto

rivaroxaban

Manufacturer:

Bayer

Distributor:

DKSH
Concise Prescribing Info
Contents
Rivaroxaban
Indications/Uses
DVT & pulmonary embolism (PE) & prevention of recurrent DVT & PE in adults. Prevention of stroke & systemic embolism in adult patients w/ non-valvular atrial fibrillation.
Dosage/Direction for Use
Treatment of DVT, PE & prevention of recurrent DVT & PE Days 1-21: 15 mg bd, max: 30 mg. Day 22 & onwards: 20 mg once daily, max: 20 mg. Moderate renal impairment (CrCl 30-50 mL) Initially, 15 mg bd for the 1st 3 wk; thereafter, 20 mg once daily. Reduce dose to 15 mg once daily if risk of bleeding outweighs risk for recurrent DVT & PE. Prevention of stroke & systemic embolism Recommended & max dose: 20 mg once daily. Moderate renal impairment (CrCl 30-50 mL/min) 15 mg once daily in patients w/ non-valvular atrial fibrillation.
Administration
Should be taken with food: For oral use. Take tab w/ food. For patients w/ difficulty swallowing, tab may be crushed & mixed w/ water or apple puree. Drink immediately. The dose should be immediately followed by food.
Contraindications
Hypersensitivity. Clinically significant active bleeding. Lesion or condition, if considered to be a 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), low molecular wt heparins (eg, enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (eg, warfarin, dabigatran etexilate, apixaban) except under specific circumstances of switching anticoagulant therapy or when 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 & lactation.
Special Precautions
Carefully observe for signs & symptoms of bleeding; discontinue use if severe haemorrhage occurs. May cause mucosal bleedings & anaemia in long term use. Perform clinical surveillance, lab testing of Hb hematocrit to detect occult bleeding. Monitor signs of bleeding complications & anaemia after initiation of treatment in patients at increased risk of bleeding. Not recommended in concomitant use w/ systemic azole antimycotics eg, ketoconazole, itraconazole, voriconazole & posaconazole or HIV protease inhibitors eg, ritonavir. Concomitant treatment w/ drugs affecting haemostasis eg, NSAIDs, acetylsalicylic acid, platelet aggregation inhibitors or other antithrombotic agents. Consider appropriate prophylaxis for patients at risk of ulcerative GI disease. Patients w/ increased bleeding risk eg, congenital or acquired bleeding disorders, uncontrolled or severe arterial HTN, other GI disease w/o active ulceration that can lead to bleeding complications eg, inflammatory bowel disease, oesophagitis, gastritis & GERD, vascular retinopathy, bronchiectasis or history of pulmonary bleeding. Not recommended in patients w/ prosthetic heart valves. Discontinue use 24 hr prior to an invasive procedure or surgical intervention & restart as soon as adequate haemostasis has been established. Increased risk of epidural or spinal haematoma resulting to long-term or permanent paralysis when neuraxial (epidural/spinal) anaesth or spinal/epidural puncture is performed especially w/ use of indwelling epidural catheters or concomitant use of drugs affecting haemostasis & traumatic or repeated epidural or spinal puncture; monitor for signs & symptoms of neurological impairment eg, leg numbness or weakness, bowel or bladder dysfunction. Do not w/draw epidural catheter <18 hr after last administration; administer next dose ≥6 hr after removal of catheter; delay treatment for 24 hr if traumatic puncture occurs. Do not use in patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended as an alternative to unfractionated heparin in patients w/ pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. May impair ability to drive & operate machinery. Increased bleeding risk in severe renal impairment (CrCl <30 mL/min); caution in use in CrCl 15-30 mL/min; not recommended in CrCl <15 mL/min. Not recommended for childn <18 yr. Increased haemorrhagic risk in the elderly.
Adverse Reactions
Anaemia including respective lab parameters; dizziness, headache; eye haemorrhage including conjunctival haemorrhage; hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GIT haemorrhage including rectal haemorrhage, GI & abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting; pruritus, rash, ecchymosis, cutaneous & SC haemorrhage; pain in extremity; urogenital tract heamorrhage including haematuria & menorrhagia, renal impairment including increased blood creatinine & urea; fever, peripheral oedema; decreased general strength & energy including fatigue & asthenia; increase in transaminases; postprocedural haemorrhage including post-op anaemia & wound haemorrhage, contusion, wound secretion; cerebral & intracranial haemorrhage.
Drug Interactions
Increased Cmax, AUC & bleeding risk w/ strong CYP3A4 & P-gp inhibitors; not recommended w/ systemic treatment w/ azole antimycotics eg, ketoconazole, itraconazole, voriconazole & posaconazole, or HIV protease inhibitors. Additive effect on anti-Factor Xa activity w/ enoxaparin. Increased bleeding risk w/ concomitant use of NSAIDs including acetylsalicylic acid & platelet aggregation inhibitors. Increased prothrombin time/INR & additive effects on aPTT, inhibition of factor Xa activity & endogenous thrombin potential when converting warfarin to Xarelto or vice versa. Decreased mean AUC & pharmacodynamic effects w/ concomitant use of rifampicin; reduced plasma conc w/ other strong CYP3A4 inducers eg, phenytoin, carbamazepine, phenobarb or St. John's Wort.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AF01 - rivaroxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
Form
Xarelto FC tab 15 mg
Packing/Price
2 × 14's
Form
Xarelto FC tab 20 mg
Packing/Price
2 × 14's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in