US FDA approved new drug Bevyxxa that contains betrixaban (factor Xa inhibitor) for the prophylactic treatment of venous thromboembolism in those adults who are hospitalized due to acute illness and have risk of thromboembolic phenomenon. FDA also indicated that this drug must not used in patients who are getting epidural anesthesia because it may increase the risk of epidural hematoma during spinal puncture.
venous thromboembolism is very common in bedridden patient especially those who are diabetics. When blood clots dislocate from its primary place and attached to lungs then it is termed as pulmonary embolism. Dislocated clots are very dangerous as they travel inside venous system and can cause blockage of blood circulation towards brain, heart or lungs.
Some risk factors that increase the chances of venous thromboembolism are orthopedic surgeries, older age, pregnancy, trauma, lack of activity for a long time and oral contraceptives. Genetic predisposition and blood disorders are also important in the pathophysiology of venous thromboembolism.
Betrixaban is basically an anticoagulant that inhibits factor Xa directly by binding with it. It has great affinity for factor Xa that's why it has shown promising results in clinical trials. It has also been observed that this drug is very useful for prevention of stroke and atrial fibrillation.
Bevyxxa/betrixaban Side effects
According to health authorities drug exhibit following side effects during clinical trials.
- Increase tendency of bleeding
- Internal hemorrhage
- Hypersensitivity reaction
- Gastrointestinal discomfort
- Vomit like feeling
- Abdominal distension
Bevyxxa/betrixaban Uses/Patient Information
US FDA approved this drug for prophylaxis or prevention of venous thromboembolism (VTE) in hospitalized patient due to acute illness because they have higher risk of venous thromboembolism as compared to those who are not bedridden. US FDA also warns that this drug must not be used in those patients who are undergoing for epidural anesthesia due to chances of spinal hematoma.
Bevyxxa/betrixaban Cost and Dosage
Bevyxxa is formulated in the form of oral dosage form (capsules) with potency of 40mg or 80mg per capsule. However, standard dosage frequency of Bevyxxa/betrixaban is 160mg orally for the first dose and 80mg orally for subsequent doses for the prophylaxis of Venous Thromboembolism. Dose titration should be considered in case of renal or hepatic impairment or Concomitant administartion of P-gp inhibitors.