其 他 安 全 警 示
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| The United Kingdom: Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that it 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. MHRA reminds patients to take 15 mg or 20 mg rivaroxaban 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.
Healthcare professionals are advised:
- 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/rivaroxaban-xarelto-reminder-that-15-mg-and-20-mg-tablets-should-be-taken-with-food
In Hong Kong, there are 6 registered pharmaceutical products containing rivaroxaban, namely Xarelto Tab 10mg (HK-57861), Xarelto Tab 20mg (HK-61395), Xarelto Tab 15mg (HK-61396), Xarelto Tablets 20mg (Italy) (HK-65785), Xarelto Tablets 10mg (Italy) (HK-65786) and Xarelto Tablets 15mg (Italy) (HK-65787). All products are registered by Bayer Healthcare Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 18 cases of adverse drug reaction related to rivaroxaban, but these cases are not related to lack of efficacy. The package insert of the 15mg and 20mg local products advise patients to take the tablets with food. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Thursday, Jul 18, 2019
Issued at HKT 17:00
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