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  • Xarelto 20 mg
    / Bayer


    Active Ingredient
    Rivaroxaban 20 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    28 X 20 mg

    partial basket chart 34118 24071

    Related information


    Dosage

    Prevention of stroke and systemic embolism: The recommended dose is 20 mg once daily, which is also the recommended maximum dose.
    Therapy with Xarelto should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding. If a dose is missed the patient should take 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.
    Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE: The recommended dose for the initial treatment of acute DVT or PE is 15 mg twice daily for the first three weeks followed by 20 mg once daily for the continued treatment and prevention of recurrent DVT and PE, as indicated below:
    Day 1 – 21: 15 mg twice daily, Maximum daily dose: 30 mg
    Day 22 and onwards: 20 mg once daily, Maximum daily dose: 20 mg
    The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4). Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE. If a dose is missed during the 15 mg twice daily treatment phase (day 1 – 21), the patient should take Xarelto immediately to ensure intake of 30 mg Xarelto per day. In this case two 15 mg tablets may be taken at once. The patient should continue with the regular 15 mg twice daily intake as recommended on the following day. If a dose is missed during the once daily treatment phase (day 22 and onwards), the patient should take 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.
    Converting from Vitamin K Antagonists (VKA) to Xarelto: For patients treated for prevention of stroke and systemic embolism, VKA treatment should be stopped and Xarelto therapy should be initiated when the International Normalized Ratio (INR) is ≤ 3.0. For patients treated for DVT , PE and prevention of recurrence, VKA treatment should be stopped and Xarelto therapy should be initiated once the INR is ≤ 2.5.
    When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto. The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used.
    Converting from Xarelto to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from Xarelto to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Xarelto can contribute to an elevated INR. In patients converting from Xarelto to VKA, VKA should be given concurrently until the INR is ≥ 2.0. For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing as guided by INR testing. While patients are on both Xarelto and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of Xarelto. Once Xarelto is discontinued INR testing may be done reliably at least 24 hours after the last dose.
    Converting from parenteral anticoagulants to Xarelto
    For patients currently receiving a parenteral anticoagulant, discontinue the parenteral anticoagulant and start Xarelto 0 to 2 hours before the time that the next scheduled administration of the parenteral medicinal product (e.g. low molecular weight heparins) would be due or at the time of discontinuation of a continuously administered parenteral medicinal product (e.g. intravenous unfractionated heparin).
    Converting from Xarelto to parenteral anticoagulants: Give the first dose of parenteral anticoagulant at the time the next Xarelto dose would be taken.
    Special populations
    Renal impairment: Limited clinical data for patients with severe renal impairment (creatinine clearance 15 – 29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased. Therefore, Xarelto is to be used with caution in these patients. Use is not recommended in patients with creatinine clearance < 15 ml/min. In patients with moderate (creatinine clearance 30 – 49 ml/min) or severe (creatinine clearance 15 – 29 ml/min) renal impairment the following dosage recommendations apply: For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, the recommended dose is 15 mg once daily. For the treatment of DVT , treatment of PE and prevention of recurrent DVT and PE: Patients should be treated with 15 mg twice daily for the first 3 weeks. Thereafter, the recommended dose is 20 mg once daily. A reduction of the dose from 20 mg once daily to 15 mg once daily should be considered if the patient’s assessed risk for bleeding outweighs the risk for recurrent DVT and PE. The recommendation for the use of 15 mg is based on PK modelling and has not been studied in this clinical setting. No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 – 80 ml/min).
    Hepatic impairment: 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.
    Elderly population: No dose adjustment.
    Body weight: No dose adjustment.
    Gender: No dose adjustment.
    Paediatric population: The safety and efficacy of Xarelto in children aged 0 to 18 years have not been established. No data are available. Therefore, Xarelto is not recommended for use in children below 18 years of age.
    Method of administration: For oral use. The tablets are to be taken with food. For patients who are unable to swallow whole tablets, Xarelto tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally. After the administration of crushed Xarelto 15 mg or 20 mg film-coated tablets, the dose should be immediately followed by food. The crushed Xarelto tablet may also be given through gastric tubes after confirmation of the correct gastric placement of the tube. The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water. After the administration of crushed Xarelto 15 mg or 20 mg film-coated tablets, the dose should then be immediately followed by enteral feeding.


    Indications

    Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age equal to or above 75 years, diabetes mellitus, prior stroke or transient ischemic attack. Treatment of Deep Vein Thrombosis (DVT), and prevention of recurrent DVT and Pulmonary Embolism (PE) following an acute DVT in adults.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Active clinically significant bleeding. Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C. Pregnancy and breast feeding.


    Special Precautions

    Clinical surveillance in line with anticoagulation practice is recommended throughout the treatment period.
    Hemorrhagic risk: In the clinical studies mucosal bleedings (i.e. epistaxis, gingival, gastrointestinal (GI), genito urinary) and anemia were seen more frequently during long term rivaroxaban treatment compared with VKA treatment. Thus, in addition to adequate clinical surveillance, laboratory testing of hemoglobin/hematocrit could be of value to detect occult bleeding, as judged to be appropriate. Several sub-groups of patients, as detailed below, are at increased risk of bleeding. These patients are to be carefully monitored for signs and symptoms of bleeding complications and anemia after initiation of treatment. See prescribing information for full details. Any unexplained fall in hemoglobin or blood pressure should lead to a search for a bleeding site.
    Renal impairment: In patients with severe renal impairment (creatinine clearance < 30 ml/min) rivaroxaban plasma levels may be significantly increased (1.6 fold on average) which may lead to an increased bleeding risk. Xarelto is to be used with caution in patients with creatinine clearance 15-29 ml/min. Use is not recommended in patients with creatinine clearance < 15 ml/min. See prescribing information for full details. Xarelto should be used with caution in patients with renal impairment concomitantly receiving other medicdbinal products that are potent inhibitors of CYP3A4 (e.g. clarithromycin, telithromycin) as PK modelling shows increased rivaroxaban concentrations in these patients.
    Other hemorrhagic risk factors: Rivaroxaban, like other antithrombotic agents, is to be used with caution in patients with an increased bleeding risk such as: Congenital or acquired bleeding disorders, uncontrolled severe arterial hypertension, other gastrointestinal disease without active ulceration that can potentially lead to bleeding complications (e.g. inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis or history of pulmonary bleeding.
    Patients with prosthetic valves: Safety and efficacy have not been studied in patients with prosthetic heart valves; therefore, there are no data to support that Xarelto 20 mg (15 mg in patients with moderate or severe renal impairment) provides adequate anticoagulation in this patient population. Treatment is not recommended for these patients.
    Patients with acute pulmonary embolism: Treatment is not recommended.
    Spinal/epidural anaesthesia or puncture: Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
    Dosing recommendations before and after invasive procedures and surgical intervention: If an invasive procedure or surgical intervention is required, treatment 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 should be assessed against the urgency of the intervention. Treatment should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate hemostasis has been established.
    Elderly population: Increasing age may increase haemorrhagic risk.
    Excipients: Xarelto contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicdbinal product.
    Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
    For full details see prescribing information.


    Side Effects

    (Common): Blood and lymphatic system disorders: Anaemia (incl. respective laboratory parameters). Nervous system disorders: Dizziness, headache. Eye disorders: Eye haemorrhage (incl. conjunctival haemorrhage). Vascular disorders: Hypotension, haematoma. Respiratory, thoracic and mediastinal disorders: Epistaxis, haemoptysis. Gastrointestinal disorders: Gingival bleeding, gastrointestinal tract haemorrhage (incl. rectal haemorrhage), gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting. Skin and subcutaneous tissue disorders: Pruritus (incl. uncommon cases of generalised pruritus), rash, ecchymosis, cutaneous and subcutaneous haemorrhage. Musculoskeletal and connective tissue disorders: Pain in extremity. Renal and urinary disorders: Urogenital tract haemorrhage (incl. haematuria and menorrhagia), renal impairment (incl. blood creatinine increased, blood urea increased). General disorders and administration site conditions: Fever, peripheral oedema, decreased general strength and energy (incl. fatigue and asthenia). Investigations: Increase in transaminases. Injury, poisoning and procedural complications: Postprocedural haemorrhage (incl. postoperative anaemia, and wound haemorrhage), contusion, wound secretion.
    For full details see prescribing information.


    Drug interactions

    The use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir). These active substances are strong inhibitors of both CYP3A4 and P-gp and therefore may increase rivaroxaban plasma concentrations to a clinically relevant degree (2.6 fold on average) which may lead to an increased bleeding risk. Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as non-steroidal anti-inflammatory medicinal products (NSAIDs), acetylsalicylic acid and platelet aggregation inhibitors. For patients at risk of ulcerative gastrointestinal disease an appropriate prophylactic treatment may be considered.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy Safety and efficacy of Xarelto have not been established in pregnant women. Studies in animals have shown reproductive toxicity. Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy, Women of child-bearing potential should avoid becoming pregnant during treatment with rivaroxaban.
    Breast feeding: Safety and efficacy of Xarelto have not been established in breast feeding women. Data from animals indicate that rivaroxaban is secreted into milk. Therefore Xarelto is contraindicated during breast feeding. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from therapy.
    For full details see prescribing information.


    Overdose

    Rare cases of overdose up to 600 mg have been reported without bleeding complications or other adverse reactions. Due to limited absorption a ceiling effect with no further increase in average plasma exposure is expected at supratherapeutic doses of 50 mg rivaroxaban or above. A specific antidote antagonising the pharmacodynamic effect of rivaroxaban is not available. The use of activated charcoal to reduce absorption in case of rivaroxaban overdose may be considered.
    For full details see prescribing information.


    Important notes

    Storage: Store at a tempreture lower than 30°C.


    Manufacturer
    Bayer Pharma AG
    Licence holder
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