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  • Xarelto 10 mg
    / Bayer


    Active Ingredient
    Rivaroxaban 10 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 X 10 mg

    partial basket chart 83857 24055

    Related information


    Dosage

    The recommended dose is 10 mg taken orally 1 x daily, with or without food. The initial dose should be taken 6 to 10 hours after surgery, provided that hemostasis has been established. The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopedic surgery. For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended. For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.
    If a dose is missed the patient should take Xarelto immediately and then continue the following day with once daily intake as before.
    Converting from Vitamin K Antagonists (VKA) to Xarelto: When converting patients from VKAs to Xarelto, International Normalized Ratio ( 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 (see sections 4.5 and 5.2).
    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. No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 – 80 ml/min) or moderate renal impairment (creatinine clearance 30- 49 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. Xarelto can be taken with or without 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.
    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.


    Indications

    Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.


    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

    Hemorrhagic risk: 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 anaemia after initiation of treatment. Any unexplained fall in haemoglobin 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. In patients with moderate renal impairment (creatinine clearance 30 – 49 ml/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations Xarelto is to be used with caution.
    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.
    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
    Patients with acute pulmonary embolism: Treatment is not recommended.
    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.
    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.
    Elderly population: Increasing age may increase haemorrhagic risk.
    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.
    See prescribing information for full details.


    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

    CYP3A4 and P-gp inhibitors: 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.
    Anticoagulants: Due to the increased bleeding risk care is to be taken if patients are treated concomitantly with any other anticoagulants.
    NSAIDs/platelet aggregation inhibitors: Care is to be taken if patients are treated concomitantly with medicdbinal products affecting hemostasis such as NSAIDs, acetylsalicylic acid, platelet aggregation inhibitors or other antithrombotic agents.
    CYP3A4 inducers: Concomitant administration of strong CYP3A4 inducers should be avoided unless the patient is closely observed for signs and symptoms of thrombosis.
    See prescribing information for full details.


    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 breastfeeding. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.
    See prescribing information for full details.


    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.
    See prescribing information for full details.


    Important notes

    Storage: Store below 30°C.


    Manufacturer
    Bayer Pharma AG
    Licence holder
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