Betrixaban is indicated for the prevention of venous thromboembolism (VTE) in adult patients who are hospitalized due to an acute medical condition and are at increased risk of thromboembolic events because of moderate or severe immobility and other contributing risk factors.

Betrixaban is a selective factor Xa inhibitor that directly blocks the active site of factor Xa without the need for a cofactor such as antithrombin III. It inhibits both free factor Xa and the prothrombinase complex, thereby reducing thrombin generation. Betrixaban does not have a direct effect on platelet aggregation.

The recommended dose of Betrixaban is an initial single dose of 160 mg, followed by 80 mg once daily. Daily oral doses should be given at the same time of day with food. The recommended duration of treatment is 35 to 42 days.

• P-gp inhibitors: May increase plasma levels of betrixaban.
• P-gp inducers: May reduce plasma levels of betrixaban.
• Anticoagulants, antiplatelets, and thrombolytics: May increase the risk of bleeding when used concomitantly.

Betrixaban is contraindicated in patients with active pathological bleeding and in those with known hypersensitivity to betrixaban.

The most commonly reported adverse effect is bleeding. Epidural or spinal hematoma may occur in patients undergoing spinal or epidural procedures.

Pregnancy: Limited data are available on the use of betrixaban in pregnant women; however, it may increase the risk of hemorrhage during pregnancy and delivery.
Lactation: No data are available regarding excretion of betrixaban in human milk or its effects on the breastfed infant or milk production.

Risk of bleeding: Monitor patients for any signs of bleeding and assess promptly if symptoms occur.
Spinal/Epidural anesthesia or puncture: Patients receiving anticoagulants are at risk of epidural or spinal hematoma, which may result in long-term or permanent paralysis. Administer the next dose no earlier than 5 hours after catheter removal; if traumatic puncture occurs, delay administration for 72 hours.
Severe renal impairment: Associated with an increased risk of bleeding.
Concomitant P-gp inhibitors: May further increase bleeding risk.

Patients with severe renal impairment: No dose adjustment is required for mild to moderate impairment (CrCl >30 mL/min). For severe impairment (CrCl 15–30 mL/min), initiate with 80 mg followed by 40 mg once daily.
Patients with hepatic impairment: No adjustment is required in mild hepatic impairment; however, use is not recommended in moderate to severe hepatic impairment.

Antiplatelet agents

Store below 30°C, protected from light and moisture. Keep the medicine out of the reach of children.