Rivaroxaban: Prescribing Guidance for the treatment of provoked venous thromboembolism (VTE)

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1 Rivaroxaban: Prescribing Guidance for the treatment of provoked venous thromboembolism (VTE) Amber Drug Level 2 Leeds We have started your patient on rivaroxaban for the treatment of provoked VTE (deep vein thrombosis, DVT or pulmonary embolism, PE). We will continue to see the patient and prescribe rivaroxaban until the patient (and their condition) is stable, (a minimum of 7 weeks). After this period the GP will be asked to take over prescribing responsibilities under this amber drug protocol. This guideline outlines the specific responsibilities of the Specialist, GP, and patient when rivaroxaban is prescribed. The link to rivaroxaban on the Leeds formulary can be found here. Prescribing Information Drug: rivaroxaban Indication: In Leeds rivaroxaban will be offered to patients with a provoked DVT and PE as part of the VTE ambulatory pathway. NICE guidance recommends that rivaroxaban should be considered as an option for the treatment of DVT and PE. Rivaroxaban is licensed for the treatment of DVT and PE and prevention of recurrent DVT and PE in adults. Treatment of provoked DVT is usually for 3 months. Treatment of provoked PE is usually for 6 months. Rivaroxaban is not licensed in pregnancy and lactation. Rivaroxaban is not licensed for use in anyone less than 18 years of age. Classification: Amber Level 2 Monitoring: Routine disease monitoring should continue. (see appendix 1). No additional monitoring specific to the drug to be undertaken by the GP. Should the patient remain on rivaroxaban longer than the standard treatment length they will then be cared for under the long term secondary prevention of VTE amber level 3 guidance. Baseline Tests: All patients should have the following tests prior to initiation by secondary care: Renal function (U&Es) Full blood count (FBC) Liver Function Test (LFT) Prothrombin time (PT) Rivaroxaban is contraindicated in hepatic disease. Rivaroxaban should be used with caution in patients with a creatinine clearance of < 50ml/min. Rivaroxaban is not recommended if creatinine clearance is <15ml/min. 1

2 Prescribing Information (cont) Creatinine clearance, (CrCL) should be calculated for: o elderly patients over 65 years 60kg or less, or o patients 60kg or less with raised creatinine. Creatinine clearance can be calculated using an appropriate renal calculator e.g. SystmOne or as follows: Estimated creatinine clearance in ml/minute = n (140-age) weight serum creatinine Weight in kilograms, use ideal body weight, (IBW) if actual weight is greater than 120% IBW IBW (kg) = (number of inches over 5ft x 2.3) + 50 (male) or 45.5 (female) Serum creatinine in micromol/litre n = 1.04 (females), 1.23 (males) Routine Tests/Monitoring: The following will be completed by secondary care at 7-14 days and 3 months: Patients should be monitored for signs of bleeding. Patients should be reviewed in terms of side effects, adherence to therapy, bleeding risk, safety of therapy. Abnormal LFTs or U&Es reported during routine blood tests not taken specifically due to rivaroxaban: If ALT increases to greater than 2 times the upper limit of normal discuss urgently with haematology. If increased creatinine reported calculate creatinine clearance (as above) If creatinine clearance is between 30-49mls/minute reduce dose to 15mg daily If creatinine clearance is between 15-30mls/minute reduce dose to 15mg daily and contact haematology If creatinine clearance is less than 15 ml/min stop treatment and contact haematology The following is a summary of prescribing information only. Consult the BNF and SPC for full and current prescribing information. The following has been added only if it differs from the BNF and SPC: Dose: Treatment duration should be guided by cause of DVT or PE, size of PE, first or recurrent event and risk factors for bleeding. See clinic referral letter for recommended dose and other clinical information for individual patient. Formulation: Rivaroxaban is available as 10mg, 15mg and 20mg tablets. Do not use 10mg tablets for a 20mg dose this will double the cost. Communication Contact Names and Details Anticoagulant office number: / / Anticoagulant office fax number:

3 Communication (continued) On call haematology registrar: LGI via switchboard SJUH Medicines Information phone number: Medicines Information Medicines Information Patient Helpline phone number: Prepared by: Dr Morag Arundel, Consultant in Acute Medicine, LTHT Dr Elizabeth (Lishel) Horn, Consultant Haematologists LTHT Razvana Akbar, Advanced Clinical Pharmacist Anticoagulation, LTHT Katherine Stirling, Consultant Pharmacist, Anticoagulation and Thrombosis, LTHT of Specialist Diagnosis of condition and ensuring other treatment options have been fully explored Assess bleeding risk with respect to reversibility of rivaroxaban Inform patient of side effects of rivaroxaban, the lack of reversal agent, what to do if a dose is missed, and the importance of reporting any symptoms of bleeding, (or anaemia) to their GP or A&E if severe. Recording that this information has been discussed Informing patients to seek urgent medical advice if they fall or have a head injury Give patient a rivaroxaban patient alert card, an anticoagulant alert card and patient information leaflet and advising them to carry them with them and show it to any healthcare provider Informing women of child-bearing age that they must use adequate contraception while on rivaroxaban Informing patient that they are responsible for attending their GP practice when requested for review To initiate treatment Liaison with the General Practitioner (GP) to take over prescribing of the amber medicine using a written request Advising GP on dose to be prescribed and any titration schedule if appropriate Outlining to the GP when therapy may be reduced and stopped assuming no relapse in patient s condition. Review periods to be stated. Responding to issues raised by GP Checking for allergies, interactions and contra-indications when taking over prescribing and when changing any treatment Report adverse effects to the specialist and where appropriate the Commission on Human Medicines/MHRA (Yellow card scheme) Prescribing the amber medicine after receiving request from secondary care clinician Routine disease monitoring should continue.monitoring the patient s overall health and wellbeing, observing patient for evidence of ADRs and liaising with secondary care clinician if necessary. 3

4 (Continued) Ensuring advice is sought from the secondary care clinician if there is any significant change in the patient s physical health status that may affect prescribing or appropriateness of the amber medicine Reducing/stopping treatment in line with secondary care clinician s original request of Patient/Carer To be responsible for taking rivaroxaban as prescribed To be responsible for taking the tablet(s) at the same time every day to help them to remember to take it If they forget to take the tablet(s) to take it as soon as they remember. Patients should not take more than one dose in a single day to make up for a forgotten dose. They should take the next tablet(s) on the following day and then carry on taking the prescribed dose once a day Contacting their GP immediately if they have taken too many rivaroxaban tablets, as this increases the risk of bleeding To understand the potential for adverse events and report these to the GP or A&E depending on severity To be aware of possible side effects which may be a sign of bleeding, (long or excessive bleeding, exceptional weakness, tiredness, paleness, dizziness, headache, unexplained swelling, breathlessness, chest pain) To carry their rivaroxaban and anticoagulant alert cards and inform any healthcare providers that they are on rivaroxaban To check with the community pharmacist that there are no interactions with this medication, when buying any over the counter medicines or herbal/homoeopathic products To check with dentists or other specialists who may prescribe medicines that there are no interactions with this medication To contact the GP, Specialist or Medicines Information patient helpline if further information or advice is needed about this medication 4

5 Appendix 1 APPENDIX 1 Flow Chart for Patients with acute provoked DVT/PE started on rivaroxaban For patients presenting to specialist for medication review or acute presentation related to VTE or anticoagulation Check patient has no contraindications to anticoagulation Review whether any thrombotic events have occurred that may indicate treatment failure Review whether any haemorrhagic symptoms have occurred or any symptoms that could be consistent with concealed bleeding Review occurrence of any other adverse effects Review co morbidities that may influence risk benefit ratio Review medication for potential interactions Ensure women of child bearing age using NOACs are using adequate suitable contraception Refer women planning pregnancy for pre-pregnancy counselling and ensure suitable contraception is continued until advice received. Remember that patients with renal impairment are at increased risk of bleeding on anticoagulants and on NOAC in particular. Bleeding (including concealed bleeding) should be considered if the patient s health deteriorates without clear cause. Follow NICE guidance for monitoring renal function but consider the risks of NOAC in this context. Stop NOAC if creatinine clearance is < 15ml/minute. Seek advice about risks of NOAC if renal function is deteriorating 5

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