Betrixaban

DEA Class; Rx

Common Brand Names; Bevyxxa

• Factor Xa Inhibitors

Active pathological bleeding

Severe hypersensitivity

Clinically relevant nonmajor bleeding (2.45%)

Epistaxis (2%)

Hematuria (2%)

Bleeding

• Major bleeding (0.67%)
• GI bleeding (0.51%)
• Intracranial hemorrhage (0.05%)
• Fatal bleeding (0.03%)

Increased risk of thrombosis in patients with triple-positive antiphospholipid syndrome

Increases bleeding risk and can cause serious and potentially fatal bleeding; promptly evaluate any signs or symptoms of blood loss; there is no established way to reverse betrixaban’s anticoagulant effect, which can persist for at least 72 hr after the last dose; protamine, vitamin K, and tranexamic acid are not expected to reverse betrixaban anticoagulant activity

Not recommended for use in patients with triple-positive 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 with direct-acting oral anticoagulants has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy

Risk of paralysis with neuraxial anesthesia (see Black Box Warnings)

Increased bleeding risk with severe renal impairment (see Dosage Modifications)

No data exist with use in pregnant women, but treatment is likely to increase risk of hemorrhage during pregnancy and delivery

Use during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition