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
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.
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 (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.