Sponsored Links
Cardiovascular disease
Also called: heart diseaseHeart conditions that include diseased vessels, structural problems and blood clots.
Most common types
Coronary artery disease
Damage or disease in the heart's major blood vessels.
High blood pressure
A condition in which the force of the blood against the artery walls is too high.
Cardiac arrest
Sudden, unexpected loss of heart function, breathing and consciousness.
Congestive heart failure
A chronic condition in which the heart doesn't pump blood as well as it should.
Arrhythmia
Improper beating of the heart, whether irregular, too fast or too slow.
Peripheral artery disease
A circulatory condition in which narrowed blood vessels reduce blood flow to the limbs.
Stroke
Damage to the brain from interruption of its blood supply.
Congenital heart disease
An abnormality in the heart that develops before birth.
Consult a doctor for medical advice
Sponsored Links
Bevyxxa (betrixaban)
Company: Portola Pharmaceuticals
Approval Status: Approved June 2017
Specific Treatments: the prophylaxis of venous thromboembolism
Therapeutic Areas: Cardiology/Vascular Diseases
Sponsored Links
General Information
Bevyxxa (betrixaban) is a factor Xa (FXa) inhibitor.
Bevyxxa is specifically indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
Bevyxxa is supplied as a capsule for oral administration. The recommended dose is an initial single dose of 160 mg, followed by 80 mg once daily, taken at the same time each day with food. The recommended duration of treatment is 35 to 42 days. Reduce dose for patients with severe renal impairment. Reduce dose for patients on P-glycoprotein (P-gp) inhibitors.
Bevyxxa is specifically indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
Bevyxxa is supplied as a capsule for oral administration. The recommended dose is an initial single dose of 160 mg, followed by 80 mg once daily, taken at the same time each day with food. The recommended duration of treatment is 35 to 42 days. Reduce dose for patients with severe renal impairment. Reduce dose for patients on P-glycoprotein (P-gp) inhibitors.
Clinical Results
FDA Approval
The FDA approval of Bevyxxa was based on APEX, a randomized, double-blind, multinational study comparing extended duration Bevyxxa to short duration of enoxaparin in the prevention of venous thromboembolic events (VTE) in an acutely medically ill hospitalized population with risk factors for VTE. Oral betrixaban for 35 to 42 days was compared with injectable enoxaparin for 6 to 14 days followed by placebo. Bevyxxa efficacy was measured in the modified Intent-to-Treat (mITT) analysis, which includes 7,441 patients assessed by a composite outcome score comprising either the occurrence of asymptomatic proximal DVT or symptomatic DVT, non-fatal PE or VTE-related death. Bevyxxa reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo (4.4 percent vs. 6.0 percent) with no significant increase in major bleeding (0.67 percent vs. 0.57 percent). The most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4 percent and 1.2 percent for betrixaban and enoxaparin, respectively.
The FDA approval of Bevyxxa was based on APEX, a randomized, double-blind, multinational study comparing extended duration Bevyxxa to short duration of enoxaparin in the prevention of venous thromboembolic events (VTE) in an acutely medically ill hospitalized population with risk factors for VTE. Oral betrixaban for 35 to 42 days was compared with injectable enoxaparin for 6 to 14 days followed by placebo. Bevyxxa efficacy was measured in the modified Intent-to-Treat (mITT) analysis, which includes 7,441 patients assessed by a composite outcome score comprising either the occurrence of asymptomatic proximal DVT or symptomatic DVT, non-fatal PE or VTE-related death. Bevyxxa reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo (4.4 percent vs. 6.0 percent) with no significant increase in major bleeding (0.67 percent vs. 0.57 percent). The most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4 percent and 1.2 percent for betrixaban and enoxaparin, respectively.
Side Effects
Adverse effects associated with the use of Bevyxxa may include, but are not limited to, the following:
SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with betrixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. The risk of these events may be increased by the use of in-dwelling epidural catheters or the concomitant use of medical products affecting hemostasis. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
- bleeding
SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with betrixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. The risk of these events may be increased by the use of in-dwelling epidural catheters or the concomitant use of medical products affecting hemostasis. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
Mechanism of Action
Bevyxxa
(betrixaban) is a factor Xa (FXa) inhibitor. It selectively blocks the
active site of FXa and does not require a cofactor (such as
Anti-thrombin III) for activity. Betrixaban inhibits free FXa and
prothrombinase activity. By directly inhibiting FXa, betrixaban
decreases thrombin generation (TG). Betrixaban has no direct effect on
platelet aggregation.
Additional Information
For
additional information regarding Bevyxxa or the prophylaxis of venous
thromboembolism (VTE) in adult patients hospitalized for an acute
medical illness who are at risk for thromboembolic complications due to
moderate or severe restricted mobility and other risk factors for VTE,
please visit http://www.bevyxxa.com/
