Rivaroxaban

DEA Class; Rx

Common Brand Names; Xarelto

Hypersensitivity

Active pathological bleeding

Patients who have had transcatheter aortic valve replacement (Tavr)

Neuraxial anesthesia (see Black Box Warnings)

Risk for thrombotic events increased with premature discontinuation (see Black Box Warnings)

Safety and efficacy have not been studied in patients with other prosthetic heart valves or other valve procedures; use not recommended in patients with prosthetic heart valves

Increases risk of bleeding and can cause serious and fatal bleeding; reports of major hemorrhages, including epidural hematomas, adrenal bleeding, and intracranial, gastrointestinal, and retinal hemorrhages; promptly evaluate S/S of blood loss and consider the need for blood replacement; discontinue with active pathological hemorrhage

Not for use with the following conditions at increased risk of bleeding in patients requiring primary VTE prophylaxis; history of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage, active cancer (i.e. undergoing acute, in-hospital cancer treatment), active gastroduodenal ulcer in the three months prior to treatment, history of bleeding in the three months prior to treatment, or dual antiplatelet therapy

Not recommended acutely as an alternative to unfractionated heparin in patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy

Do not remove an indwelling epidural or intrathecal catheter before at least 2 half-lives have elapsed (ie, 18 hr in patients aged 20-45 years and 26 hr in patients aged 60-76 years), after last administration; do not administer next dose earlier than 6 hr after removal of catheter; if traumatic puncture occurs, delay administration for 24 hr

Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly; consider dose adjustment or discontinuation of therapy in patients who develop acute renal failure while on therapy

Not recommended for use in patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome (APS); for patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies]), treatment has been associated with an increased rate of recurrent thrombotic events compared with vitamin K antagonist therapy

Use with caution in pregnant women and only if the potential benefit justifies the potential risk to the mother and fetus (see Pregnancy)

Limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes

Drug detected in human milk