Xarelto® fi the rst oral
DVTtreatment Xarelto®
single-drug approach for
Actual size : Oral anticoagulation for the treatment
of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults
For further information on this NICE guidance please visit:
http://guidance.nice.org.uk/TA261/Guidance/pdf/English 1. National Institute for Health and Clinical Excellence. Technology appraisal guidance 261. July 2012.
Xarelto® 15 and 20mg fi lm-coated tablets (rivaroxaban) Prescribing Information (Refer to
full Summary of Product Characteristics (SmPC) before prescribing) Presentation: 15mg/20mg rivaroxaban tablet. Indication(s): Treatment of deep vein thrombosis (DVT) & prevention of recurrent DVT & pulmonary embolism (PE) following an acute DVT in adults. Posology & method of administration: Dosage – 15mg b.i.d. for 3 weeks followed by 20mg o.d. for continued treatment & prevention of recurrent DVT & PE; take with food. Refer to SmPC for information on duration of therapy & converting to/from Vitamin K antagonists (VKA) or parenteral anticoagulants. Renal impairment: mild (creatinine clearance 50-80 ml/min) – no dose adjustment necessary; moderate (creatinine clearance 30-49 ml/min) & severe (creatinine clearance 15-29 ml/min: limited data indicates rivaroxaban plasma concentrations are signifi cantly increased, use with caution) – 15mg b.i.d for 3 weeks, reduce maintenance dose to 15mg o.d; patients with creatinine clearance <15 ml/min – use not recommended. Hepatic impairment: Do not use in patients with hepatic disease associated with coagulopathy & clinically relevant bleeding risk including cirrhotic patients with Child-Pugh B & C. Paediatrics: Not recommended. Contraindications: Hypersensitivity to active substance or any excipient; clinically signifi cant active bleeding; hepatic disease associated with coagulopathy & clinically relevant bleeding risk including cirrhotic patients with Child-Pugh B & C; pregnancy & breastfeeding. Warnings & precautions: Clinical surveillance in line with anticoagulant practice is recommended throughout the treatment period. There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine. If clinically indicated, rivaroxaban levels can be measured by calibrated quantitative anti-Factor Xa tests. In studies, mucosal bleedings & anaemia were seen more frequently during long term rivaroxaban treatment compared with VKA treatment – haemoglobin/haematocrit testing may be of value in detecting occult bleeding. The following sub-groups of patients are at increased risk of bleeding & should be carefully monitored after treatment initiation: Use with caution in patients with severe renal impairment or with renal impairment concomitantly receiving potent inhibitors of CYP3A4 (PK models show increased rivaroxaban concentrations); in patients treated concomitantly with medicines affecting haemostasis; in patients with an increased bleeding risk such as congenital or acquired bleeding disorders, uncontrolled severe arterial hypertension, active ulcerative gastrointestinal disease (consider appropriate prophylactic treatment for at-risk patients), recent gastrointestinal ulcerations, vascular retinopathy, recent intracranial or intracerebral haemorrhage, intraspinal or intracerebral vascular abnormalities, recent brain/spinal /ophthalmological surgery, bronchiectasis or history of pulmonary bleeding. Use is not recommended in patients: with creatinine clearance <15 ml/min; receiving concomitant systemic treatment with azole-antimycotics or HIV protease inhibitors; with prosthetic heart valves; for treatment of acute pulmonary embolism. If invasive procedures or surgical intervention are required, stop Xarelto®
use at least 24 hours
UK.PH.GM.XAR.2012.546 August 2012
beforehand. Restart use as soon as possible provided adequate haemostasis has been established. See SmPC for full details. Xarelto®
contains lactose. Interactions: Concomitant use with strong
inhibitors of both CYP3A4 & P-gp not recommended as increased rivaroxaban plasma concentrations to a clinically relevant degree are observed. Avoid co-administration with dronedarone. Use with caution in patients concomitantly receiving other anticoagulants, NSAIDs or platelet aggregation inhibitors due to the increased bleeding risk. Use with caution in patients concomitantly receiving CYP3A4 inducers as they may reduce rivaroxaban plasma concentrations. Pregnancy & breastfeeding: Contraindicated. Effects on ability to drive and use machines: Adverse reactions like syncope & dizziness are common. Patients experiencing these effects should not drive or use machines. Undesirable effects: Very common: urogenital tract haemorrhage (in women <55 years in DVT-t trials). Common: anaemia, dizziness, headache, syncope, eye haemorrhage, tachycardia, hypotension, haematoma, epistaxis, GI tract haemorrhage, GI & abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, pruritus, rash, ecchymosis, pain in extremities, urogenital tract haemorrhage, fever, peripheral oedema, decreased general strength & energy, increase in transaminases, post- procedural haemorrhage, contusion, wound secretion. Serious: cf. CI/Warnings and Precautions – in addition: thrombocythaemia, allergic reactions, occult bleeding/haemorrhage from any tissue (e.g. cerebral & intracranial, cutaneous & subcutaneous, muscle), haemoptysis, haemarthrosis which may lead to complications (incl. compartment syndrome, renal failure, fatal outcome), abnormal hepatic function, renal impairment, hyperbilirubinaemia, jaundice, pseudoaneurysm formation following percutaneous intervention. Prescribers should consult SmPC in relation to full side-effect information. Overdose: No specifi c antidote is available. Legal Category: POM. Package Quantities and Basic NHS Costs: 15mg – 28 tablets: £58.80, 42 tablets: £88.20, 100 tablets: £210.00; 20mg – 28 tablets: £58.80, 100 tablets £210.00 MA Number(s): EU/1/08/472/011-21 Further information available from: Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, U.K. Telephone: 01635 563000. Date of preparation: June 2012.
Xarelto® is a trademark of the Bayer Group.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Bayer plc. Tel.: 01635 563500, Fax.: 01635 563703, Email:
phdsguk@bayer.co.uk
© Bayer Healthcare BHP
Simple, proven, predictable anticoagulation
NOW
RECOMMENDED BY NICE1
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