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    Rivaroxaban (Xarelto ) - Reminder That 15 MG and 20 MG Tablets Should Be Taken With Food - GOV - UK

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    Moisés Ponce
    The MHRA has received reports of lack of efficacy of the drug Rivaroxaban in patients taking the 15 mg or 20 mg tablets without food. The document reminds healthcare professionals to advise patients to take the 15 mg or 20 mg Rivaroxaban tablets with food to help ensure proper absorption of the drug. Clinical trials showed food intake did not affect absorption of lower dose tablets but the 15 mg and 20 mg tablets should be taken with a meal for optimal absorption. The patient information leaflet for these higher doses has been revised to emphasize taking Rivaroxaban with food.

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    Rivaroxaban (Xarelto ) - Reminder That 15 MG and 20 MG Tablets Should Be Taken With Food - GOV - UK

    Uploaded by

    Moisés Ponce
    57 views2 pages
    The MHRA has received reports of lack of efficacy of the drug Rivaroxaban in patients taking the 15 mg or 20 mg tablets without food. The document reminds healthcare professionals to advise patients to take the 15 mg or 20 mg Rivaroxaban tablets with food to help ensure proper absorption of the drug. Clinical trials showed food intake did not affect absorption of lower dose tablets but the 15 mg and 20 mg tablets should be taken with a meal for optimal absorption. The patient information leaflet for these higher doses has been revised to emphasize taking Rivaroxaban with food.

    Original Description:

    Xarelto

    Original Title

    Rivaroxaban (Xarelto▼)_ reminder that 15 mg and 20 mg tablets should be taken with food - GOV.UK

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    The MHRA has received reports of lack of efficacy of the drug Rivaroxaban in patients taking the 15 mg or 20 mg tablets without food. The document reminds healthcare professionals to advise patients to take the 15 mg or 20 mg Rivaroxaban tablets with food to help ensure proper absorption of the drug. Clinical trials showed food intake did not affect absorption of lower dose tablets but the 15 mg and 20 mg tablets should be taken with a meal for optimal absorption. The patient information leaflet for these higher doses has been revised to emphasize taking Rivaroxaban with food.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    57 views2 pages

    Rivaroxaban (Xarelto ) - Reminder That 15 MG and 20 MG Tablets Should Be Taken With Food - GOV - UK

    Uploaded by

    Moisés Ponce
    The MHRA has received reports of lack of efficacy of the drug Rivaroxaban in patients taking the 15 mg or 20 mg tablets without food. The document reminds healthcare professionals to advise patients to take the 15 mg or 20 mg Rivaroxaban tablets with food to help ensure proper absorption of the drug. Clinical trials showed food intake did not affect absorption of lower dose tablets but the 15 mg and 20 mg tablets should be taken with a meal for optimal absorption. The patient information leaflet for these higher doses has been revised to emphasize taking Rivaroxaban with food.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    18/7/2019 Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food - GOV.

    UK

    GOV.UK
    1. Home (https://www.gov.uk/)
    2. Drug Safety Update (https://www.gov.uk/drug-safety-update)

    Rivaroxaban (Xarelto▼): reminder that 15 mg and 20


    mg tablets should be taken with food
    MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients
    taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban
    tablets with food.

    Published 17 July 2019

    From:
    Medicines and Healthcare products Regulatory Agency (https://www.gov.uk/government/organisations/medicines-
    and-healthcare-products-regulatory-agency)

    Therapeutic area:
    Cardiovascular disease and lipidology (https://www.gov.uk/drug-safety-update?
    therapeutic_area%5B%5D=cardiovascular-disease-lipidology), Haematology (https://www.gov.uk/drug-safety-update?
    therapeutic_area%5B%5D=haematology)

    Contents
    Importance of taking rivaroxaban 15 mg and 20 mg tablets with food
    Further information about rivaroxaban

    Advice for healthcare professionals:


    remind patients to take rivaroxaban 15 mg or 20 mg tablets with food
    for patients who have difficulty swallowing, tablets can be crushed and mixed with water or apple puree
    immediately before taking; this mixture should be immediately followed by food
    rivaroxaban 2.5 mg and 10 mg tablets can be taken with or without food
    report suspected adverse drug reactions, including any suspected events associated with lack of
    efficacy to rivaroxaban, on a Yellow Card (https://yellowcard.mhra.gov.uk/)

    Importance of taking rivaroxaban 15 mg and 20 mg tablets with food


    Clinical trials of rivaroxaban showed that food intake does not affect absorption of 2.5 mg or 10 mg tablets, while
    absorption of 20 mg tablets was optimal when taken with high-fat, high-calorie meal. For this reason, rivaroxaban
    15 mg and 20 mg tablets are to be taken with food.

    https://www.gov.uk/drug-safety-update/rivaroxaban-xarelto-reminder-that-15-mg-and-20-mg-tablets-should-be-taken-with-food 1/2
    18/7/2019 Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food - GOV.UK

    MHRA has received a small number of reports of patients taking rivaroxaban 15 mg or 20 mg who experienced a
    thromboembolic event, which the reporter suspected was due to the patient taking the tablets on an empty
    stomach.

    The section of the Patient Information Leaflet for rivaroxaban 15 mg and 20 mg tablets that advises patients how
    to take their medicine has been revised to emphasise patients must take rivaroxaban with a meal and the tablets
    should be swallowed preferably with water.

    Further information about rivaroxaban


    Xarelto (https://www.medicines.org.uk/emc/product/2793/smpc) (rivaroxaban) is a direct inhibitor of coagulation factor
    Xa with the following indications:

    Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for
    prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with
    elevated cardiac biomarkers (2.5 mg dose)
    Co-administered with ASA, for the prevention of atherothrombotic events in adult patients with coronary
    artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events (2.5
    mg)
    Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement
    surgery (10 mg)
    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 of 75 years and older, diabetes
    mellitus, prior stroke or transient ischaemic attack (15 mg and 20 mg)
    Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT
    and PE in adults (10 mg, 15 mg, and 20 mg).

    Article citation: Drug Safety Update volume 12, issue 12: July 2019: 3.

    Published 17 July 2019

    Explore the topic


    Alerts and recalls (https://www.gov.uk/health-and-social-care/medicines-medical-devices-blood-vigilance-safety-alerts-
    alerts-and-recalls)

    https://www.gov.uk/drug-safety-update/rivaroxaban-xarelto-reminder-that-15-mg-and-20-mg-tablets-should-be-taken-with-food 2/2

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