Xarelto Film Coated Tablet 2.5mg

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Dosage and method of administration** **4.2.1 Method of administration** Oral use **4.2.2 Recommended usual dose** ACS The recommended vascular protection regimen is one tablet of 2.5 mg Xarelto twice daily. Patients should also take a daily dose of 75–100 mg ASA or a daily dose 75–100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine. CAD or PAD The recommended vascular protection regimen for patients with CAD or PAD is one tablet of 2.5 mg Xarelto twice daily in combination with a daily dose of 75–100 mg ASA. **4.2.3 Duration of treatment** Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks. In patients with ACS, extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited (see section ‘Pharmacodynamic properties’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients with an acute thrombotic event or vascular procedure and a need for dual antiplatelet therapy, the continuation of Xarelto 2.5 mg twice daily should be evaluated depending on type of event or procedure and antiplatelet regimen. Safety and efficacy of Xarelto 2.5 mg twice daily in combination with ASA plus clopidogrel/ticlopidine has only been studied in patients with recent ACS. Dual antiplatelet therapy has not been studied in combination with Xarelto 2.5 mg twice daily in patients with CAD or PAD ( _see section ‘Pharmacodynamic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.4 Method and frequency of administration** Treatment with Xarelto should be started as soon as possible after stabilization of the ACS event (including revascularization procedures); at the earliest 24 hours after admission to hospital and at the time when parenteral anticoagulation therapy would normally be discontinued. In patients diagnosed with CAD or PAD, treatment with Xarelto 2.5 mg twice daily in combination with ASA 75–100 mg once daily can be started at any time. One 2.5 mg tablet of Xarelto should be taken twice daily. Xarelto 2.5 mg tablets may be taken with or without food. For patients who are unable to swallow whole tablets, Xarelto tablet may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally. The crushed Xarelto tablet may be given through gastric tubes. Gastric placement of the tube should be confirmed before administering Xarelto. The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water. (see section ‘Pharmacokinetic properties’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) **4.2.5 Missed Dose** If a dose is missed the patient should continue with the regular 2.5 mg Xarelto dose as recommended at the next scheduled time. The dose should not be doubled to make up for a missed dose. **4.2.6 Additional information on special populations** **4.2.6.1 Patients with hepatic impairment** Xarelto is contraindicated in patients with hepatic disease which is associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C ( _see section ‘Contraindications’ and ‘Pharmokinetic properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No dose adjustment is necessary in patients with other hepatic diseases ( _see section ‘Pharmacokinetic Properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.6.2 Patients with renal impairment** No dose adjustment is required if Xarelto is administered in patients with mild (Creatinine clearance (CrC): 80–50 mL/min) or moderate (CrC: <50–30 mL/min) renal impairment ( _see section ‘Pharmacokinetic Properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Limited clinical data for patients with severe renal impairment (CrC: <30–15 mL/min) indicate that rivaroxaban plasma levels are significantly increased in this patient population. Therefore Xarelto must be used with caution in these patients (see section ‘Special Warnings and Precautions for Use’, ‘Pharmacokinetic Properties’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Use of Xarelto is not recommended in patients with CrC: <15 mL/min. ( _see section ‘Special Warnings and Precautions for Use’, ‘Pharmacokinetic Properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.6.3 Converting from Vitamin K Antagonists (VKA) to Xarelto** When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto. The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used ( _see section ‘Interaction with other medicinal products and other forms of interaction’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.6.4 Converting from Xarelto to Vitamin K antagonists (VKA)** There is a potential for inadequate anticoagulation during the transition from Xarelto to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Xarelto can contribute to an elevated INR. In patients converting from Xarelto to VKA, VKA should be given concurrently until the INR is ≥2.0. For the first two days of the conversion period, standard initial VKA dosing should be used followed by VKA dosing guided by INR testing. While patients are on both Xarelto and VKA, the INR should not be tested earlier than 24hours (after the previous dose but prior to the next dose of Xarelto. Once Xarelto is discontinued INR testing may be done reliably 24hours after the last dose ( _see section ‘Interaction with other medicinal products and other forms of interaction’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.6.5 Converting from parenteral anti-coagulants to Xarelto** For patients currently receiving a parenteral anticoagulant, Xarelto should be started 0 to 2 hours before the time of the next scheduled administration of the parenteral medicinal drug (e.g. low molecular weight heparins) or at the time of discontinuation of a continuously administered parenteral drug (e.g. intravenous unfractionated heparin). **4.2.6.6 Converting from Xarelto to parenteral anti-coagulants** Give the first dose of parenteral anticoagulant at the time that the next Xarelto dose would be taken. **4.2.6.7 Paediatric population** The safety and efficacy of Xarelto in children aged 0 to 18 years have not been established. No data are available. Therefore, Xarelto is not recommended for use in children below 18 years of age. **4.2.6.8 Geriatric patients** No dose adjustment is required based on age. The risk of bleeding increases with increasing age ( _see section ‘Pharmacokinetic Properties’ and ‘Special warnings and precautions for use’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.6.9 Gender** No dose adjustment is required based on gender ( _see section ‘Pharmacokinetic Properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.6.10 Body weight** No dose adjustment is required based on body weight ( _see section ‘Pharmacokinetic Properties’ and ‘Special warnings and precautions for use’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **4.2.6.11 Ethnic differences** No dose adjustment is required based on ethnic differences ( _see section ‘Pharmacokinetic Properties’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).