Bevyxxa
Bevyxxa Uses, Dosage, Side Effects, Food Interaction and all others data.
Bevyxxa 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. Bevyxxa inhibits free factor Xa and prothrombinase activity. By directly inhibiting factor Xa, Bevyxxa decreases thrombin generation (TG). Bevyxxa has no direct effect on platelet aggregation.
Bevyxxa is an oral anticoagulant that excerts its action by preventing thrombin generation without having a direct effect on platelet aggregation .
Trade Name | Bevyxxa |
Availability | Discontinued |
Generic | Betrixaban |
Betrixaban Other Names | Betrixaban |
Related Drugs | Eliquis, apixaban, Pradaxa, dabigatran, Fragmin, dalteparin |
Type | |
Formula | C23H22ClN5O3 |
Weight | Average: 451.91 Monoisotopic: 451.1411173 |
Protein binding | Betrixaban is reported to be present a proteing binding of about 60% . |
Groups | Approved, Investigational |
Therapeutic Class | Anti-platelet drugs |
Manufacturer | |
Available Country | United States, |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Bevyxxa is used 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.
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 Bevyxxa 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.
Bevyxxa is also used to associated treatment for these conditions: Venous Thromboembolism
How Bevyxxa works
Bevyxxa is a cofactor-independent direct inhibitor of the Factor Xa and inhibits free and prothrombinase-bound Factor Xa .
Dosage
Bevyxxa dosage
The recommended dose of Bevyxxa 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.
Side Effects
Most common adverse reaction is bleeding, epidural or spinal hematoma may develop during spinal/epidural anesthesia or puncture.
Toxicity
Bevyxxa presents a minimal hepatotoxicity, which is the main adverse effect found in this class of drugs. Some of the major adverse effects of Bevyxxa are bleeding or hypersensitivity .
Precaution
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 Bevyxxa. Do not administer the next Bevyxxa dose earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of Bevyxxa for 72 hours.
Severe Renal Impairment: Increase risk of bleeding events.
Concomitant P-gp Inhibitors: Increase risk of bleeding events.
Interaction
P-gp Inhibitors: Increase the blood level of Bevyxxa.
P-gp Inducers: Decrease the blood level of Bevyxxa.
Anticoagulants, Antiplatelets and Thrombolytics: May increase the risk of bleeding
Food Interaction
- Avoid herbs and supplements with anticoagulant/antiplatelet activity. These herbs may increase the risk of bleeding. Examples include garlic, ginger, bilberry, danshen, piracetam, and ginkgo biloba.
- Take at the same time every day.
- Take with food. Bevyxxa should be taken with food. The Cmax and AUC of betrixaban are decreased by approximately 60% and 55% when administered together with a 900 calorie meal.
[Moderate] ADJUST DOSING INTERVAL: Food reduces the oral bioavailability of betrixaban.
When administered with a low-fat (900 calories; 20% fat) or high-fat (900 calories; 60% fat) meal, betrixaban peak plasma concentration (Cmax) and systemic exposure (AUC) decreased relative to administration in the fasting state by an average of 70% and 61%, respectively, with the low-fat meal and 50% and 48%, respectively, with the high-fat meal.
The effect of food on betrixaban pharmacokinetics could be observed for up to 6 hours after meal intake.
MANAGEMENT: The manufacturer recommends taking betrixaban at the same time each day with food.
Bevyxxa Drug Interaction
Major: enoxaparin, ketorolacUnknown: lorazepam, diphenhydramine, lactobacillus rhamnosus gg, hydromorphone, formoterol / mometasone, epinephrine, fluticasone nasal, ipratropium, lidocaine topical, methylprednisolone, famotidine, tiotropium, oseltamivir, topiramate, acetaminophen / hydrocodone, multivitamin, cholecalciferol, levalbuterol
Bevyxxa Disease Interaction
Volume of Distribution
The apparent volume of distribution os 32 L/kg .
Elimination Route
Bevyxxa presents a rapid absorption at a dose of 80 mg. Its peak plasma concentration is registered within 3-4 hours after oral administration in healthy humans. The oral bioavailability is 34%, and it can be reduced with the consumption of food. Specifically, the Cmax and AUC is reduced by an average of 70% and 61% with a low-fat meal, and 50% and 48% with a high-fat meal compared to the fasted state, an effect which is apparent up to six hours following food intake.
Half Life
Bevyxxa presents a long half-life of between 19-27 hours .
Clearance
Bevyxxa presents a minimal renal clearance (being 5-7% of the administered dose) .
Elimination Route
Bevyxxa is reported to present mainly a gastrointestinal elimination route, it has been shown that even 85% of it gets disposed in the feces and only 11% of it can be found in the urine .
Pregnancy & Breastfeeding use
Use in Pregnancy: There are no data with the use of Bevyxxa 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 Bevyxxa or its metabolites in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.
Contraindication
Bevyxxa is contraindicated in patients with active pathological bleeding. It is also contraindicated in patients with severe hypersensitivity reaction to Bevyxxa
Storage Condition
Protect from light and moisture, store below 30°C. Keep the medicine out of reach of children.
Innovators Monograph
You find simplified version here Bevyxxa
Bevyxxa contains Betrixaban see full prescribing information from innovator Bevyxxa Monograph, Bevyxxa MSDS, Bevyxxa FDA label