Rivaroxaban: Amber Drug Guidance for the prevention of stroke and systemic embolism in patients with non-valvular AF

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1 Leeds Rivaroxaban: Amber Drug Guidance for the prevention of stroke and systemic embolism in patients with non-valvular AF Amber Drug Level 3 (amber drug with monitoring requirements) We have started your patient on rivaroxaban. When the patient (and their condition) is stable on the medication, you will be asked to take over prescribing and monitoring responsibilities under this amber drug protocol. This drug requires monitoring. This guideline outlines the specific responsibilities of the Specialist, GP, and patient when rivaroxaban is prescribed. The general responsibilities for prescribing and monitoring amber drugs can be found here (link provided) Prescribing Information Indication for therapy (including licensing information): In Leeds Rivaroxaban will be: Offered to people with non-valvular atrial fibrillation and a CHA 2 DS 2 -VASc score of 2 or above (taking bleeding risk into account) Considered for men with non-valvular atrial fibrillation and a CHA 2 DS 2 -VASc score of 1 for the prevention of stroke and systemic embolism, following an informed discussion with the patient about the anticoagulation options and basing the choice of treatment on their clinical features and preferences. Rivaroxaban is licensed for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and one or more of the risk factors: Previous stroke, transient ischemic attack, or systemic embolism (SEE) Left ventricular ejection fraction < 40 % Symptomatic heart failure, Class 2 Age 75 years New York Heart Association (NYHA) Age 65 years associated with one of the following: diabetes mellitus, coronary artery disease, or hypertension Rivaroxaban is not licensed in pregnancy and lactation. Rivaroxaban is not licensed for use in anyone less than 18 years of age. (Also note contraindications below) Classification: Amber Level 3 Monitoring: Required 1

2 Prescribing Information (continued) Baseline Tests: All patients should have their renal function (U&Es), full blood count (FBC) and liver function (LFTs) tested. Rivaroxaban is contraindicated in hepatic disease and not recommended if CrCl <30ml/min. Baseline prothrombin time (PT) should be done if the patient is not on warfarin. If patients are switching from warfarin an international normalised ratio (INR) must be taken. Routine Tests/Monitoring: Monitor urea and electrolytes (U&E s), to ensure renal function is still adequate. See appendix 1 Monitor patients for signs of bleeding. FBC tests to monitor haemoglobin can be of assistance in monitoring for bleeding. Patients should be reviewed in terms of side effects, adherence to therapy, bleeding risk, safety of therapy and drug interactions See appendix 1. Rivaroxaban has a shorter half life than warfarin so the anticoagulant effect will reduce more rapidly on stopping treatment. o Half life 5-9 hours with egfr > 50ml/min o Half life hours if egfr < 50ml/min monitor LFTs as these can be affected by rivaroxaban (see appendix 1). Adherence should be monitored. The prothrombin time (PT) is raised in patients taking rivaroxaban but has limited sensitivity and cannot give precise quantification of anticoagulant effect. It may be useful in patients who are bleeding to assist in determining whether significant anticoagulant activity is present. The following is a summary of prescribing information only. Consult the current BNF and SPC for full prescribing information. Dose: The recommended dose of Rivaroxaban for prevention of stroke is 20mg daily, taken as a single dose with food. This dose should be reduced to 15mg daily if CrClis 30-49ml/min. Treatment should be continued long-term. See clinic referral letter for recommended dose and other clinical information for particular patient. Formulation: Rivaroxaban is available as 10mg, 15mg and 20mg tablets. NB. Do not use 10mg tablets for a 20mg dose. This will double the cost. Adverse drug reactions: See current BNF and SPC for full list. 2

3 Prescribing Information (cont) The most common side effects (with a frequency of <1 in 10 to >1 in 100) are: anaemia, dizziness, headache, hypotension, haematoma, epistaxis, haemoptysis, GI haemorrhage, diarrhoea, abdominal pain, dyspepsia, nausea, abnormal LFTs (transaminases), genitourinary haemorrhage, pruritus, renal impairment, fever, peripheral oedema etc Contra-indications: Hypersensitivity to the active substance or to any of the excipients Clinically significant bleeding Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C Pregnancy and breast-feeding CrCl <15 ml/min Patients on concomitant azole-antimycotics such as ketoconazole, itraconazole, voriconazole and posaconazole, dronedarone or HIV protease inhibitors. These are strong CYP and P-glycoproein (Pgp) inhibitors and can increase the levels of rivaroxaban. Cautions: Care should be taken to manage treatment for patients undergoing surgery or dental treatment and in cases of overdose or underdose. See LHP for advice in these circumstances or contact Medicines Information. Rivaroxaban should be used with caution in patients with; i. Haemorrhagic risk - Any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site. ii. Renal impairment - Rivaroxaban is to be used with caution in patients with CrCl ml/min. patients with ClCr< 30ml/min will be managed by the acute trust. iii. Congenital or acquired bleeding disorders iv. Uncontrolled severe arterial hypertension v. Active ulcerative gastrointestinal disease vi. Recent gastrointestinal ulcerations vii. Vascular retinopathy viii. Recent intracranial or intracerebral haemorrhage ix. Intraspinal or intracerebral vascular abnormalities x. Recent brain, spinal or ophthalmological surgery xi. Bronchiectasis or history of pulmonary bleeding. Interactions: The prescriber will ensure that any changes to concurrent medication and prescribing of new drugs do not have implications for interacting with rivaroxaban, noting particular caution with; ketoconazole, itraconazole, ritonavir avoid; increased risk of bleeding. rifampicin, carbamazepine, phenytoin, St John's Wort - decreased rivaroxaban concentrations. clarithromycin and erythromycin - potentially increased rivaroxaban concentrations. Care is to be taken if patients are treated concomitantly with NSAIDs 3

4 Prescribing Information (cont) (including acetylsalicylic acid) and platelet aggregation inhibitors because these medicinal products typically increase the bleeding risk Note: This list is not exhaustive and the current BNF/SPC should be referred to for more information. Pregnancy/breast-feeding: Rivaroxaban is contraindicated in patients who are pregnant or breast-feeding. Patients who are women of child-bearing age must be informed that they should use adequate contraception whilst on rivaroxaban. Communication Hospital Specialist to GP The hospital specialist will inform the GP when they have initiated rivaroxaban and refer the GP to the amber drug guidance on LHP The hospital specialist will request that the GP accepts the patient after the first review see appendix 1.The patient will have at least 14 days supply of medication following the first review letter. Hospital care specialist will ensure that arrangements are in place for GPs to obtain advice and support where needed. The hospital specialist will provide the GP with details of the prescription and any decisions regarding interacting medication/cautions, length of course if not lifelong, and will ask the GP to provide further care and ongoing prescription. GP to Hospital Specialist If the GP has concerns over the prescribing of rivaroxaban, they will contact the NOAC clinic or initiating hospital specialist as soon as possible. Patients who develop a contraindication or CrCl <30ml/min/ to rivaoxaban will have the drug stopped and a fast track referral made back to the specialist clinic (See also NICE CKD Guidelines). Responsibilities of Specialist Assess the suitability of the patient for treatment in line with NICE CG 180 o Assess bleeding risk with respect to reversibility of rivaroxaban o Assess Hepatic function (rivaroxaban contra-indicated in hepatic disease with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C) o Assess renal function (not recommended if CrCl <15ml/min) Confirm absence of any contra indication to rivaroxaban. Consider cautions to rivaroxaban use including risk of bleeding and ClCr 15-29ml/min Confirm absence of any drug interaction with any of the patient s concurrent medication or put in place measures to reduce toxicity from the combination if essential (See SPC) Baseline tests (U&E, LFT) prior to initiation and communication of results to the GP. Inform GP of initiation 4

5 Responsibilities of Specialist (continued) Responsibilities of GP Responsibilities of GP (continued) Assess patient at 3-6 weeks see appendix 1. If patient stable request GP take over responsibility for prescribing and monitoring. The patient will have at least 14 days supply of medication following the 3-6 week assessment Inform patient of side effects of rivaroxaban, the need for long term monitoring, 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. Record that this information has been discussed. Inform patients to seek urgent medical advice if they fall or have a head injury Give patient a Rivaroxaban patient alert card and patient information leaflet and advise them to carry it with them and show it to any healthcare provider. Inform women of child-bearing age that they must use adequate contraception while on rivaroxaban Inform the Leeds anticoagulant clinic that the patient has been switched and add patient to the rivaroxaban database. When switching from warfarin ensure INR<3 before initiating rivaroxaban. Inform patient that they are responsible for attending their GP practice when requested, for blood samples and assessment. Only accept patients who meet the criteria in NICE CG 180 Prescribe rivaroxaban as recommended by the specialist Report adverse effects to the specialist and where appropriate the Commission on Human Medicines/MHRA (Yellow card scheme). Refer to specialist clinic or initiating consultant if it is suspected that the patient is getting serious side effects (including significant dyspepsia, falling Hb, occurrence of thrombotic event, deteriorating LFTs) requiring investigation or termination of rivaroxaban. Ensure that if coagulation tests are requested rivaroxaban is noted on the extra information section. Alcohol doesn t interact with rivaroxaban but will increase the risk of bleeding so patients should be advised to stick to safe limits and this should be re-enforced at review. Participate in audit when requested GP practice must have systems to ensure reviews are undertaken as per appendix 1 GP practice must have systems to ensure reviews are undertaken as per appendix 1 Review the patient in terms of side effects, adherence to therapy, bleeding risk, safety of therapy and drug interactions See appendix 1 5

6 Monitor for adverse effects of rivaroxaban - including blood tests (U&E and FBC, LFTs ). See appendix 1. NB Renal function should be checked as per appendix 1, unless patient is at risk of deteriorating renal function (ie. hypovolaemia or dehydration acute illness eg sepsis, new heart failure, introduction of drugs which may impair renal function etc) when it should be checked more frequently. Responsibilities of Patient/Carer Contact Details To take responsibility for taking rivaroxaban as prescribed. To adhere to their treatment. o Patients should be advised to take the tablet(s) at the same time every day to help them to remember to take it. o If the patient forgets to take their Rivaroxaban dose, they should take it as soon as they remember. o All patients should be advised to contact their doctor immediately if they have taken too many Rivaroxaban tablets, as this increases the risk of bleeding. o Patients should not take more than one tablet in a single day to make up for a forgotten dose. They should take the next tablet on the following day and then carry on taking one tablet once a day. o Patients should be advised not to stop taking Rivaroxaban without talking to their doctor first. To attend their GP practice when requested, for blood samples to monitor their treatment Immediately report any symptoms, side effects or bleeding to their GP or A&E depending on severity. To carry their Xarelto alert card and inform any healthcare providers that they are on rivaroxaban. To check with community pharmacist that there are no interactions with rivaroxaban, when buying any over the counter medicines or herbal/homoeopathic products. To contact the GP, Specialist, community pharmacist or Medicines Information patient helpline if further information or advice is needed about rivaroxaban. Contact Details NOAC clinic number; Appendix 1 Medicines Information phone number; Medicines Information ; Medicines Information Patient Helpline phone number; Prepared by: Razvana Akbar Advanced Clinical Pharmacist Katherine Stirling Consultant Pharmacist Approved by: Shared Management of Medicines Group APPENDIX 1 6

7 7

8 Appendix 1 8

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