Anticoagulants, antiplatelets, NSAIDs and SSRIs/SNRIs. Edoxaban should be used in patients with NVAF and high CrCl only after a careful evaluation of the individual thromboembolic and bleeding risk. In the ENGAGE AF-TIMI 48 study there was a significant improvement in net clinical outcome (first stroke, SEE, major bleed, or all-cause mortality; mITT population, overall study period) in favour of edoxaban, HR (95% CI): 0.89 (0.83, 0.96); p = 0.0024, when edoxaban 60 mg treatment group was compared to warfarin. Therefore, use of edoxaban is not recommended in these patients. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. It's the first and only antidote to reverse bleeding in people taking apixaban (Eliquis), rivaroxaban (Xarelto), or edoxaban (Savaysa). Concomitant use of medicines affecting haemostasis may increase the risk of bleeding. Edoxaban is not recommended as an alternative to UFH in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of edoxaban have not been established in these clinical situations. Vaginal bleeds were reported commonly in women under the age of 50 years, while it was uncommon in women over the age of 50 years. The t½ for oral administration is 10 - 14 hours. Eliquis (apixaban) is a drug used for blood clots, such as in deep vein thrombosis (DVT) or atrial fibrillation (AFib). Complication rates, that is, how often complications occur, vary across the United Kingdom. Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that edoxaban passes the placenta, Lixiana is contraindicated during pregnancy (see section 4.3). If you've had a blood clot (DVT or pulmonary embolism) you'll normally take edoxaban for at least 3 months. Edoxaban 15 mg is not indicated as monotherapy, as it may result in decreased efficacy. Due to the high plasma protein binding edoxaban is not expected to be dialysable. In the warfarin group, the median TTR (INR 2.0 to 3.0) was 65.6%. Edoxaban had no effect on the Cmax and AUC of quinidine. Brand Name Marevan Pradaxa Xarelto Eliquis Lixiana Class of drug All five are anticoagulants: medicines made to stop blood from clotting rapidly. Table 1: Summary of posology in NVAF and VTE (DVT and PE). Steady state concentrations are achieved within 3 days. Exposure to the other metabolites is less than 5%. HDPE bottles with a PP screw cap containing 90 film-coated tablets. Co-administration of proton-pump inhibitors had no relevant impact on edoxaban exposure. You could ask your pharmacist for advice on other ways to remember your medicines. A specific antidote antagonising the pharmacodynamic effect of edoxaban is not available. In animal reproduction studies, rabbits showed increased incidence of gallbladder variations at a dosage of 200 mg/kg which is approximately 65 times the maximum recommended human dose (MRHD) of 60 mg/day based on total body surface area in mg/m2. The anticoagulant effect of edoxaban cannot be reliably monitored with standard laboratory testing. Rivaroxaban. b Primary safety endpoint: clinically relevant bleeding (composite of major and clinically relevant non-major bleeding). If you often forget doses, it may help to set an alarm to remind you. Population PK modeling indicates that exposure approximately doubles in patients with severe renal impairment (CrCl 15 – 29 mL/min) relative to patients with normal renal function. Direct acting oral anticoagulants (DOACs) including edoxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome. Talk to your doctor or pharmacist to find out why you've been recommended a particular medicine. low molecular weight heparin (LMWH), fondaparinux): Discontinue subcutaneous anticoagulant and start edoxaban at the time of the next scheduled subcutaneous anticoagulant dose. CI = confidence interval, CRNM = clinically relevant non-major, n = number of subjects with events, N = number of subjects in safety population, yr = year. If you have atrial fibrillation you might need to take edoxaban long term or even for the rest of your life. Once a stable INR of ≥ 2.0 is achieved, the parenteral anticoagulant should be discontinued and the VKA continued. Unlike warfarin, DOACs do not require regular international normalized ratio (INR) monitoring. The safety profile of edoxaban is based on two Phase 3 studies (21,105 patients with NVAF and 8,292 patients with VTE (DVT and PE)), and from post-authorisation experience. • Dronedarone: Dronedarone 400 mg twice daily for 7 days with a single concomitant dose of edoxaban 60 mg on day 5 increased edoxaban AUC and Cmax by 85% and 46%, respectively. In a population pharmacokinetic analysis of the ENGAGE AF-TIMI 48 study, peak and total exposure in Asian patients and non-Asian patients were comparable. Edoxaban should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4). There is a linear correlation between edoxaban plasma concentration and anti-FXa activity regardless of renal function. Close menu. Given the predictable, dose-proportional pharmacokinetic profile of edoxaban, the bioavailability results from this study are likely applicable to lower edoxaban doses. Table 12 below shows the edoxaban anti-FXa activity by CrCl category for each indication. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of edoxaban. This can be useful for them to know in case of a medical emergency. Try to take it at the same time every day. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products). After taking renal function and body weight into account, age had no additional clinically significant effect on edoxaban pharmacokinetics in a population pharmacokinetic analysis of the pivotal Phase 3 study in NVAF (ENGAGE AF-TIMI 48). Lixiana is indicated in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Lixiana as prescribed. Appendix 1. avoid playing contact sports or other activities that can cause an injury - such as football, rugby, hockey and horse riding, wear gloves when you use sharp objects like scissors, knives and gardening tools, stop wet shaving or removing hair with wax - use an electric razor or hair-removing cream instead, take dentures (false teeth) or retainers out for a few hours a day, if you wear them, to give your gums a rest - don't wear dentures or retainers that don't fit properly, tell your doctor, dentist or nurse that you take edoxaban before you have any medical or dental procedures or surgery - this includes vaccinations and routine appointments with the dental hygienist, you get bruises that happen for no reason, or bruises that are larger than you'd expect or that keep growing in size, you get nosebleeds that last longer than 10 minutes, you have blood in your vomit or you're coughing up blood, you have any bleeding from a cut or injury that won't stop or slow down, tiredness and lack of energy, shortness of breath, noticeable heartbeats (heart palpitations) and pale skin - these can be signs of, feeling or being sick (nausea or vomiting), you get a skin rash that may include itchy, red, swollen, blistered or peeling skin, your mouth, face, lips, tongue or throat start swelling, any other anticoagulant, such as warfarin or enoxaparin. The primary efficacy endpoint was the recurrence of symptomatic VTE, defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE in subjects during the 12-month study period. The alcohol can increase edoxaban's effect and make you more likely to bleed. a A subject can be represented in multiple rows. PT, INR, aPTT and anti-FXa correlate linearly with edoxaban concentrations. How long you need to take edoxaban will depend on why you are taking it. There's no firm evidence to suggest that taking edoxaban will reduce fertility in either men or women. UFH, LMWH (enoxaparin, dalteparin, etc. These include ASA, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and chronic nonsteroidal anti-inflammatory drugs (NSAIDs) (see section 4.5). This medicinal product does not require any special storage conditions. The current manuscript is the second update of the original Practical Guide, published in 2013 [Heidbuchel et al. The plasma area under the curve (AUC) for subjects with mild (CrCl > 50 - 80 mL/min), moderate (CrCl 30 - 50 mL/min) and severe (CrCl < 30 mL/min but not undergoing dialysis) renal impairment was increased by 32%, 74%, and 72%, respectively, relative to subjects with normal renal function (see section 4.2 for dose reduction). In vitro plasma protein binding is approximately 55%. For transoesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Lixiana treatment should be started at least 2 hours before cardioversion to ensure adequate anticoagulation (see sections 5.1 and 5.2). It tells healthcare professionals that you're taking an anticoagulant. This is because these types of sports could lead to an injury, which would further increase the risk of bleeding. Intravenous unfractionated heparin (UFH): Discontinue the infusion and start edoxaban 4 hours later. It makes your blood clot more slowly. You can continue to take part in non contact sports such as running, athletics, cycling, tennis and badminton. Apixaban is a pyrazolopyridine that is 7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide substituted at position 1 by a 4-methoxyphenyl group and at position 6 by a 4-(2-oxopiperidin-1-yl)phenyl group. However, there is limited clinical experience with the use of this product in individuals receiving edoxaban. Edoxaban is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. Within this population 1,826 had a CrCl > 100 ml/min and received edoxaban 60 mg in accordance with dosing criteria outlined in the SmPC. The median study follow-up for both the edoxaban 60 mg and 30 mg treatment groups was 2.8 years. If it happens, keep taking the edoxaban, but tell your doctor if the bleeding bothers you or doesn't stop. Edoxaban works by stopping a clotting factor called factor Xa from working. for severe epistaxis), surgical haemostasis with bleeding control procedures, fluid replacement and haemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anaemia or coagulopathy) or platelets. A pint of lager or beer is usually 2 to 3 units of alcohol. There are three intravenous antidotes currently under development for the reversal of direct oral anticoagulants. Toxicity. There don't seem to be any lasting harmful effects from taking it for many months and years. Pediatrics: Edoxaban is not recommended for use in children until ongoing studies establish its pharmacokinetics, pharmacodynamics, safety, and efficacy in these patients. However, the European Heart Rhythm Association (EHRA) recommends that all direct-acting oral anticoagulants (DOACs) can be started when the INR is 2 or less [ Steffel, 2018 ]. Visit Yellow Card for further information. The concomitant chronic use of high dose ASA (325 mg) with edoxaban is not recommended. However, if taking edoxaban makes you feel dizzy or lightheaded, then don't drive or ride until it goes away. Edoxaban was excreted in the breast milk of lactating rats. Crushed Lixiana tablets are stable in water and apple puree for up to 4 hours. Abbreviations: N = number of subjects in mITT population overall study period; mITT = modified intent to treat; n = number of patients in subgroup; HR = hazard ratio versus warfarin; CI = confidence interval. The number of subjects experiencing the adjudicated composite endpoint of stroke/transient ischaemic attack (TIA)/systemic embolic event (SEE) efficacy events was limited and included 2 stroke events in the edoxaban 60 mg group (0.7%; 95% CI: 0.1% to 2.4%) and 3 stroke events in the edoxaban 75 mg group (1%; 95% CI: 0.2% to 2.9%). Edoxaban decreased the Cmax and AUC of concomitantly administered verapamil by 14% and 16%, respectively. A 4 hour haemodialysis session reduced total edoxaban exposures by less than 9%. Overdose with edoxaban may lead to haemorrhage. Do not take aspirin or ibuprofen while you're taking edoxaban unless a doctor has said it's OK to. The primary safety endpoint was clinically relevant bleeding (major or clinically relevant non-major). In the Hokusai-VTE study the net clinical outcome (recurrent VTE, major bleed, or all-cause mortality; mITT population, overall study period) HR (95% CI) was 1.00 (0.85, 1.18) when edoxaban was compared to warfarin. It can increase your risk of side effects. When suggestions are available use up and down arrows to review and ENTER to select. Compared with warfarin it has fewer drug interactions.. Never take more than 1 dose in a single day. Take your tablet as soon as you remember. Therapy with edoxaban in NVAF patients should be continued long term. Pregnancy and breast-feeding (see section 4.6). In the comparator arm, subjects received initial heparin therapy concurrently with warfarin, titrated to a target INR of 2.0 to 3.0, followed by warfarin alone. In clinical pharmacology studies, healthy subjects received rivaroxaban 20 mg once daily, dabigatran 150 mg twice daily, or apixaban 5 mg twice daily, followed by a single dose of edoxaban 60 mg on day 4. Apixaban, Edoxaban and Rivaroxaban: Management of haemorrhage, surgery, or other invasive procedures Dabigatran - management of haemorrhage, surgery and other invasive procedures. There was a significant risk reduction in the edoxaban 60 mg treatment group compared with the warfarin group in major bleeding (2.75%, and 3.43% per year, respectively) [HR (95% CI): 0.80 (0.71, 0.91); p = 0.0009], ICH (0.39%, and 0.85% per year, respectively) [HR (95% CI): 0.47 (0.34, 0.63); p < 0.0001], and other types of bleeding (Table 6). They are usually mild and don't last long, but talk to your pharmacist or doctor if these side effects bother you or don't go away: In rare cases, edoxaban can cause a serious allergic reaction (anaphylaxis). The efficacy results for pre-specified major subgroups (with dose reduction as required), including age, body weight, gender and status of renal function were consistent with the primary efficacy results for the overall population studied in the trial. Concomitant treatment with any other anticoagulants e.g. Take your next dose at the usual time, and then carry on as normal. To bookmark a medicine you must sign up and log in. For patients with body weight ≤ 60 kg, the recommended dose is 30 mg edoxaban once daily (see section 5.2). You can have vaccinations while taking edoxaban. The use of Lixiana with other P-gp inhibitors including HIV protease inhibitors has not been studied. Table 5: Number of ischaemic strokes/SEE by CrCl category in the ENGAGE AF-TIMI 48, mITT analysis set overall study. Depending on what caused the blood clot, you might need to take it for longer. This can lead to serious side effects. It's usual to bleed more easily than normal while you're taking edoxaban. Edoxaban is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 4.3). You can drink alcohol while taking edoxaban, so long as you stick to the national guidelines of no more than 14 units a week for men and women. Selected from data included with permission and copyrighted by First Databank, Inc. The adverse reactions are classified according to the MedDRA system organ class (SOC) and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). Edoxaban is not normally recommended during pregnancy or while breastfeeding. Unchanged edoxaban is the predominant form in plasma. Fortunately, emergency physicians and surgeons now have an antidote called andexanet alfa (Andexxa). Continue typing to refine. After accounting for body weight, gender had no additional clinically significant effect on edoxaban pharmacokinetics in a population pharmacokinetic analysis of the Phase 3 study in NVAF (ENGAGE AF-TIMI 48). warning (a) reduced efficacy in nonvalvular atrial fibrillation patients with creatinine clearance (crcl) > 95 ml/min (b) premature discontinuation of savaysa increases the risk of ischemic events (c) spinal/epidural hematoma Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Secondary efficacy endpoints included: composite of stroke, SEE, and cardiovascular (CV) mortality; major adverse cardiovascular event (MACE), which is the composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal SEE, and death due to CV cause or bleeding; composite of stroke, SEE, and all-cause mortality.
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