BetriXa80 mg

BetriXa 80 mg is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness and at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

Anti-platelet drugs

BetriXa 80 mg is a factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. BetriXa 80 mg inhibits free factor Xa and prothrombinase activity. By directly inhibiting factor Xa, BetriXa 80 mg decreases thrombin generation (TG). BetriXa 80 mg has no direct effect on platelet aggregation.

The recommended dose of BetriXa 80 mg 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.

The recommended dose of BetriXa 80 mg 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: Increase the blood level of BetriXa 80 mg.P-gp Inducers: Decrease the blood level of BetriXa 80 mg.Anticoagulants, Antiplatelets and Thrombolytics: May increase the risk of bleeding

BetriXa 80 mg is contraindicated in patients with active pathological bleeding. It is also contraindicated in patients with severe hypersensitivity reaction to BetriXa 80 mg

Most common adverse reaction is bleeding, epidural or spinal hematoma may develop during spinal/epidural anesthesia or puncture.

Use in Pregnancy: There are no data with the use of BetriXa 80 mg in pregnant women, but treatment is likely to increase the risk of hemorrhage during pregnancy and delivery.Lactation: No data are available regarding the presence of BetriXa 80 mg or its metabolites in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

Risk of Bleeding: Can cause bleeding. Promptly evaluate any signs or symptoms of blood loss.Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. Do not remove an epidural catheter earlier than 72 hours after the last administration of BetriXa 80 mg. Do not administer the next BetriXa 80 mg dose earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of BetriXa 80 mg for 72 hours.Severe Renal Impairment: Increase risk of bleeding events. Concomitant P-gp Inhibitors: Increase risk of bleeding events.

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

Patients with Severe Renal Impairment: No dose adjustment is needed for mild or moderate renal impairment (CrCl>30 mL/min). For patients with severe renal impairment (CrCl≥15 to <30 mL/min) the recommended dose of BetriXa 80 mg is an initial single dose of 80 mg followed by 40 mg once daily.Patients with Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Avoid use in patients with moderate to severe hepatic impairment.

Anti-platelet drugs

BetriXa 80 mg is a factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. BetriXa 80 mg inhibits free factor Xa and prothrombinase activity. By directly inhibiting factor Xa, BetriXa 80 mg decreases thrombin generation (TG). BetriXa 80 mg has no direct effect on platelet aggregation.

Use in Pregnancy: There are no data with the use of BetriXa 80 mg in pregnant women, but treatment is likely to increase the risk of hemorrhage during pregnancy and delivery.Lactation: No data are available regarding the presence of BetriXa 80 mg or its metabolites in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

Patients with Severe Renal Impairment: No dose adjustment is needed for mild or moderate renal impairment (CrCl>30 mL/min). For patients with severe renal impairment (CrCl≥15 to <30 mL/min) the recommended dose of BetriXa 80 mg is an initial single dose of 80 mg followed by 40 mg once daily.Patients with Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Avoid use in patients with moderate to severe hepatic impairment.