Labeling Update for Xarelto

Labeling Update for Xarelto
Labeling Update for Xarelto

The Food and Drug Administration (FDA) announced that it has approved an update to the prescribing information for Xarelto (rivaroxaban; Janssen).

The new prescribing information states that the 10mg tablets may also be crushed immediately prior to use and administered via applesauce or nasogastric (NG) or gastric feeding tube, similar to the 15mg and 20mg tablets. The 10mg tablet does not need to be followed with food or enteral feeding, although this is still required for the 15mg and 20mg tablets.

RELATED: Xarelto Shows Consistent Results in Post-Marketing Studies

Xarelto is an oral Factor Xa inhibitor approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; to treat deep vein thrombosis (DVT), pulmonary embolism (PE); to reduce the risk of recurrence of DVT, PE following 6 months treatment for DVT, PE; and for prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.

For more information visit FDA.gov.

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