BetriXa 80mg

BetriXa 80mg

Generic: Betrixaban

Manufacturer

Square Pharmaceuticals PLC

Therapeutic Class

Anti-platelet drugs

Storage Conditions

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

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Description

Indications

BetriXa 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.

Pharmacology

Betrixaban 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. Betrixaban inhibits free factor Xa and prothrombinase activity. By directly inhibiting factor Xa, Betrixaban decreases thrombin generation (TG). Betrixaban has no direct effect on platelet aggregation.

Dosage & Administration

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.

Interaction

P-gp Inhibitors: Increase the blood level of BetriXa.
P-gp Inducers: Decrease the blood level of BetriXa.
Anticoagulants, Antiplatelets and Thrombolytics: May increase the risk of bleeding

Contraindications

Betrixaban is contraindicated in patients with active pathological bleeding. It is also contraindicated in patients with severe hypersensitivity reaction to Betrixaban

Side Effects

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

Pregnancy & Lactation

Use in Pregnancy: There are no data with the use of Betrixaban 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 Betrixaban or its metabolites in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

Precautions & Warnings

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. Do not administer the next BetriXa dose earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of BetriXa for 72 hours.

Severe Renal Impairment: Increase risk of bleeding events.

Concomitant P-gp Inhibitors: Increase risk of bleeding events.

Use in Special Populations

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 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.

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