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1 NHS EAST LANCASHIRE CCG & NHS BLACKBURN WITH DARWEN CCG DVT Primary Care Prescribing Pathway Introduction Version 1.2/January 2013 Introduction Blackburn with Darwen and East Lancashire Clinical Commissioning Groups (CCGs), working with local hospital specialists, have designed a clinical pathway for the diagnosis and management of DVT in primary care, the detail of which is included in Local Enhanced Service specifications. This Prescribing pathway supports clinicians who will be managing patients under the LES, and provides advice which is in line with the relevant NICE guidance and good clinical practice. Background to DVT Venous thromboembolism (VTE) is a condition in which a blood clot (a thrombus) forms in a vein, most commonly in the deep veins of the legs or pelvis. This is known as deep vein thrombosis, or DVT. The thrombus can dislodge and travel in the blood, particularly to the pulmonary arteries. This is known as pulmonary embolism, or PE. Failure to diagnose and treat DVTs correctly can result in fatal PE. However, diagnosis of DVT is not always straightforward. Primary care management of DVT This primary care prescribing pathway guidance document should be read in conjunction with the relevant service specifications covering DVT assessment and management in primary care. The DVT Management locally enhanced service is to be delivered in conjunction with the LES for DVT Assessment (incorporating Wells Score and D-Dimer). The purpose of the DVT Management locally enhanced service is to provide a primary care based DVT Management service that is clinically safe and cost effective. To assist clinicians diagnosing and treating DVT this Prescribing pathway document reproduces some information from the LES specifications, notably the reference to the two-level Wells score, and the place of testing and ultrasound imaging. The Prescribing pathway specifically covers the treatment of adults with suspected or confirmed DVT who are suitable for treatment with oral rivaroxaban (Xarelto ). This Prescribing pathway does not cover children or young people aged under 18, or women who are pregnant or breastfeeding. The Prescribing pathway will assume that prescribers will use a drug's summary of product characteristics to inform decisions made with individual patients. The Prescribing pathway consists of a number of parts: DVT Patient Pathway DVT patient pathway informed by NICE guidance Rivaroxaban for DVT Treatment Prescribing information DVT Investigation & Treatment Proforma 1

2 DVT Patient Pathway (Reference NICE CG 144 (June 2012) Patient presents with signs and symptoms of DVT Examination to exclude other causes Two-level Wells score test DVT Likely Two-level DVT Wells 2 points DVT Unlikely Two-level DVT Wells 1 point or less result? result? Start oral anticoagulation* Start oral anticoagulation* DVT unlikely however test must be used in conjunction with the full clinical context of the patient. There is a known low level of possible false results. No clinical diagnosis should be based on the results of the alone. Follow up with a laboratory assessment if felt necessary based on clinical judgement. DVT Re-scan 6 8 DVT Not DVT days later DVT Not DVT STOP oral anticoagulation DVT Not DVT STOP oral anticoagulation *NOTE If scan can be performed within 4 hours, issue a prescription but advise patient only to have the prescription dispensed and commence treatment if the scan result is If wait for the scan is > 4 hours, initiate treatment Notes - All patients presenting with VTE should have a full clinical history and examination undertaken with the aim of detecting underlying conditions contributing to the development of thrombosis and assessing suitability for antithrombotic therapy - Unselective screening for cancer in patients with DVT is not recommended - Patients who have a or inadequate initial scan but who have a persisting clinical suspicion of DVT or whose symptoms do not settle should have a repeat ultrasound scan 2 - After deep vein thrombosis affecting a lower limb, the use of well fitted below-knee graduated elastic compression stockings for two years should be encouraged to reduce the risk of post-phlebitic syndrome

3 NHS EAST LANCASHIRE CCG & NHS BLACKBURN WITH DARWEN CCG DVT Primary Care Prescribing Pathway Rivaroxaban (Xarelto ) for DVT Treatment Prescribing information Version 1.2/January 2013 This guide is to be used to support the appropriate use of rivaroxaban (Xarelto ) for the treatment of deep vein thrombosis (DVT) by GPs commissioned to provide the Local Enhanced Service for DVT management in primary care. It includes the following information: Indications Counselling checklist Dosing recommendations Initiation whilst awaiting a scan Review Populations potentially at higher risk of bleeding Perioperative management Pregnancy breastfeeding Overdose How to manage bleeding complications INDICATIONS for Rivaroxaban covered by this document Treatment of DVT and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. Rivaroxaban (Xarelto ) patient alert card and patient information The prescriber must provide a patient alert card to each patient prescribed rivaroxaban (Xarelto ) 15mg or 20mg (contained within the patient booklet A Patient s Guide to Deep Vein Thrombosis Treatment available from the manufacturer or CCG). The patient alert card will inform treating physicians and dentists about the patient s anticoagulation treatment and will contain emergency contact information. Please instruct patients to carry the patient alert card with them at all times and present it to every health care provider. Counselling checklist 1. Patient alert card go through each point, keep at hand dose & duration of treatment possible side effects and what to do impact on dental treatment advice on planning pregnancy or become pregnant affect on sports and travel when and how to seek medical help 2. Importance of compliance 3. Non-reversibility of rivaroxaban & bleeding risk 4. Missed dose advice 5. Avoid OTC aspirin/ibuprofen where possible 6. Take with food 7. Need to request GP to arrange further supply 8. Expect dose change from 15mg twice daily to 20mg once a day after 3 weeks DVT DOSING RECOMMENDATIONS WEEK 1 TO 3 - Initially treat with 15mg twice daily with food for the first three weeks. WEEK 4 ONWARDS - The initial treatment is followed by 20mg once daily with food for another 3 months (3 x 28 tablets of 20mg). (See separate dose adjustment advice for renal impairment on page5) Duration of treatment 3 months treatment - Confirmed proximal DVT continue the maintenance dose of rivaroxaban for 3 months. Short-term treatment (3 months) is recommended for those with transient risk factors such as recent surgery and trauma. After 3 months treatment at maintenance dose, assess the risks and benefits of continuing treatment. Unprovoked proximal DVT - Consider extending beyond 3 months if their risk of VTE recurrence is high and there is no additional risk of major bleeding. Discuss with the patient the benefits and risks of extending their treatment. Longer duration of treatment - Consider longer treatment for permanent risk factors or idiopathic (unprovoked) deep vein thrombosis if their risk of VTE recurrence is high and there is no additional risk of major bleeding. Discuss with the patient the benefits and risks of extending their treatment. Seek advice from haematology if unsure. Experience with rivaroxaban in this indication for more than 12 months is limited. 3

4 General risk factors for VTE recurrence Thrombophilia History/family history of VTE Pregnancy/recent childbirth Bedridden > 3days Age > 60 years Recent surgery in last 4 wks IV drug user Smoker Obesity Travel >4hrs in last 5 wks HRT or oral contraception Cancer Acute medical illness Patients with renal impairment: Normal or mild renal impairment egfr >50 Day 22 and onwards then 20 mg once daily for 3 months (3 x 28 days) Moderate to severe renal impairment egfr Day 22 and onwards then 20 mg once daily for 3 months (3 x 28 days). A reduction of dose to 15mg once daily should be considered if assessed risk of bleeding outweighs risk of recurrent DVT and PE. Renal impairment egfr <15 Not recommended Patients with renal impairment are at a higher risk of haemorrhage. Rivaroxaban (Xarelto ) should also be used with caution in patients with renal impairment taking concomitant potent inhibitors of CYP3A4 (e.g. systemic azoleantimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir), or dronaderone. INITIATION OF RIVAROXABAN WHILST AWAITING A SCAN DVT is likely - For those patients in whom the diagnosis of a DVT is likely based on the two-level Wells score, and for whom a proximal leg vein ultrasound scan is not available within 4 hours, 1 week (14 x 15mg tablets) treatment with rivaroxaban should be initiated (as well as performing a test). For those patients in whom the diagnosis of a DVT is likely based on the two-level Wells score, and for whom a proximal leg vein ultrasound scan is available within 4 hours, a prescription for 1 week (14 x 15mg tablets) treatment with Rivaroxaban should be issued with instructions only to have dispensed and start treatment if the scan is. GP communication with the patient must be within the same day. Check renal function. Remember to stop treatment if the diagnosis of DVT is disproved. DVT is unlikely - For those patients in whom the diagnosis of a DVT is unlikely based on the two-level Wells score, and for whom a proximal leg vein ultrasound scan is not available within 4 hours, but a test is, 1 week (14 x15mg tablets) treatment with rivaroxaban should be initiated. For those patients in whom the diagnosis of a DVT is unlikely based on the two-level Wells score, and for whom a proximal leg vein ultrasound scan is available within 4 hours, but a test is, a prescription for 1 week (14 x15mg tablets) treatment with Rivaroxaban should be issued with instructions only to have dispensed and start treatment if the scan is. GP communication with the patient must be within the same day. Check renal function. Remember to stop treatment if the diagnosis of DVT is disproved. Missed dose: Twice daily treatment period (15mg twice a day for the first three weeks): If a dose is missed, the patient should take rivaroxaban (Xarelto) immediately to ensure intake of 30mg rivaroxaban (Xarelto ) per day. Continue with the regular 15mg twice daily intake on the following day. Once daily treatment period (beyond three weeks): If a dose is missed, the patient should take rivaroxaban (Xarelto ) immediately and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose. REVIEW OF PATIENTS Once a diagnosis of DVT is confirmed patients should be reviewed near the end of their 3 month treatment duration. For those patients who continue onto longer durations of treatment, they should be reviewed at least every 3-6 months, depending on the individual clinical circumstances. 4

5 POPULATIONS POTENTIALLY AT HIGHER RISK OF BLEEDING Any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site. Several subgroups of patients are at increased risk of bleeding and should be carefully monitored for signs and symptoms of bleeding complications: Patients with hepatic impairment: Rivaroxaban (Xarelto ) is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients with Child Pugh B and C. Patients concomitantly receiving other medicinal products: - Use of rivaroxaban (Xarelto ) is not recommended with systemic azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir), or dronaderone. Take care with drugs affecting haemostasis such as NSAIDs, acetylsalicylic acid, platelet aggregation inhibitors or other antithrombotic agents. Consider GI prophylaxis with a daily proton pump inhibitor (PPI), especially in those on drugs affecting haemostasis, older persons and/or those with additional risk factors. Patients with other haemorrhagic risk factors such as: - uncontrolled severe arterial hypertension (locally defined as systolic BP >180 or diastolic BP >115) - active ulcerative gastrointestinal disease - recent gastrointestinal ulcerations - vascular retinopathy - recent intracranial/intracerebral or genitourinary haemorrhage - intraspinal or intracerebral vascular abnormalities - recent brain, spinal or ophthalmological surgery - bronchiectasis or history of pulmonary bleeding - congenital or acquired bleeding disorders. PREGNANCY/BREASTFEEDING Rivaroxaban (Xarelto ) is contraindicated during pregnancy and breastfeeding. Women of child-bearing potential should avoid becoming pregnant during treatment with Rivaroxaban (Xarelto ). PERIOPERATIVE MANAGEMENT If an invasive procedure or surgical intervention is required, rivaroxaban (Xarelto ) should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician. If the procedure cannot be delayed the increased risk of bleeding due to rivaroxaban (Xarelto ) should be assessed against the urgency of the intervention. Rivaroxaban (Xarelto ) should be restarted as soon as possible after the invasive procedure or surgical intervention provided the clinical situation allows and adequate haemostasis has been established. OVERDOSE Due to limited absorption a ceiling effect with no further increase in average plasma exposure is expected at supratherapeutic doses of 50mg rivaroxaban (Xarelto ) and above. The use of activated charcoal to reduce absorption in case of overdose may be considered. HOW TO MANAGE BLEEDING COMPLICATIONS There is currently very limited clinical experience with the use of products in individuals to reverse the effects of rivaroxaban (Xarelto ). Should bleeding complications arise in a patient receiving rivaroxaban (Xarelto ), the next rivaroxaban (Xarelto ) administration should be delayed or treatment discontinued as appropriate. Individualised bleeding management may include: Symptomatic treatment, such as mechanical compression, surgical intervention, fluid replacement Haemodynamic support; blood product or component transfusion For life-threatening bleeding that cannot be controlled with the above measures, administration of a specific procoagulant reversal agent should be considered, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (r-fviia). Due to the high plasma protein binding rivaroxaban (Xarelto ) is not expected to be dialysable. REPORTING SUSPECTED ADVERSE REACTIONS Rivaroxaban (Xarelto ) is a black triangle drug and all suspected reactions (including those not considered to be serious) should be reported through the Yellow Card Scheme. 5

6 NHS EAST LANCASHIRE CCG & NHS BLACKBURN WITH DARWEN CCG DVT Primary Care Prescribing Pathway DVT Investigation & Treatment Proforma Version 1.1/January 2013 A. Patient information Name Address GP DOB NHS No. Tel B. Pre-test probability of DVT Two level DVT Wells Score D. Suitable for primary care management with rivaroxaban? Clinical feature Points Clinical feature Tick Active cancer in last 6/12 1 YES proceed to consider treatment Paralysis, paresis or recent leg plaster Recently bedridden for 3/7 or more, or major surgery within 4/ NO - due to one or more of the following reasons (or another reason) REFER TO SECONDARY CARE IMMEDIATELY Pregnancy or breastfeeding/post-partum Tenderness along the distribution of the deep venous system 1 Age <18 years Entire leg (calf and thigh) swollen 1 Currently on warfarin or low molecular weight heparin (LMWH e.g. tinzaparin) Calf swelling 3 cm larger than asymptomatic side 1 Symptoms of PE Pitting oedema confined to/worse in the symptomatic leg Collateral superficial veins (nonvaricose) 1 1 Potential bleeding lesions e.g. GI ulcers, GU, pulmonary, intracranial/spinal or GI bleed <4/52 ago, varices, CNS vascular abnormalities, aneurysm, trauma/surgery, vascular retinopathy, bronchiectasis (not exclusive list) Previously documented DVT 1 Hepatic disease associated with coagulopathy An alternative diagnosis is at least as likely as DVT 2 Congenital or acquired bleeding disorders Total score Systolic BP >180 or diastolic BP >115 Clinical probability simplified score Points Active cancer within 6 months (refer for LMWH consideration e.g. tinzaparin) DVT likely DVT unlikely 2 points or more 1 point or less Anticipated compliance problems even with support (e.g. mental illness or alcohol/drug misuse) C. D-Dimer test result Undertaken in practice Y / N Severe renal impairment (CKD stage 5) egfr <15 ml/min/1.73 m 2 Azole antifungals (e.g. fluconazole, itraconazole etc.) or HIV protease inhibitor or dronaderone Positive Negative No result Not app 6

7 E. Treating venous thromboembolism (VTE) Rivaroxaban dosing: Renal function Day Dosing schedule Normal or mild renal impairment egfr >50 Day 22 and onwards then 20 mg once daily for 3 months (3 x 28 days) Moderate to severe renal impairment egfr Day 22 and onwards then 20 mg once daily for 3 months (3 x 28 days). A reduction of dose to 15mg once daily should be considered if assessed risk of bleeding outweighs risk of recurrent DVT and PE. Renal impairment egfr <15 Not recommended Advice: Missed dose during day 1 21, two 15 mg tablets may be taken at once (max 30mg/day) F. Duration of treatment 3 months treatment - Confirmed proximal DVT continue the maintenance dose of rivaroxaban for 3 months. Short-term treatment (3 months) is recommended for those with transient risk factors such as recent surgery and trauma. After 3 months treatment at maintenance dose, assess the risks and benefits of continuing treatment. Longer duration of treatment - Consider longer treatment for permanent risk factors or idiopathic (unprovoked) deep vein thrombosis if their risk of VTE recurrence is high and there is no additional risk of major bleeding. Discuss with the patient the benefits and risks of extending their treatment. Seek advice from haematology if unsure. Experience with rivaroxaban in this indication for more than 12 months is limited. Duration.. General risk factors for VTE recurrence for reference Thrombophilia History/family history of VTE Recent surgery in last 4 Age > 60 years wks Obesity Travel >4hrs in last 5 wks Smoker Oral contraception IV drug user Bedridden > 3 days Pregnancy / recent childbirth HRT Acute medical illness Cancer G. Mechanical prophylaxis Proximal deep vein thrombosis Offer below-knee graduated compression stockings with an ankle pressure greater than 23 mmhg (Class 3 stockings, or class 2 stockings if these are poorly tolerated) to patients with proximal DVT a week after diagnosis or when swelling is reduced sufficiently and if there are no contraindications and: advise patients to continue wearing the stockings for at least 2 years ensure that the stockings are replaced two or three times per year or according to the manufacturer's instructions advise patients that the stockings need to be worn only on the affected leg or legs. H. Results & Observations Results Date Result Date of first scan No DVT Confirmed DVT Date of repeat scan (if applicable) No DVT Confirmed DVT 7

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