BetriXa – 40 mg Capsule/pcs

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 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.

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

Severe Renal Impairment: Increase risk of bleeding events.

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

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 Betrixaban 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.

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