BetriXa Capsule 40 mg

Uses

BetriXa Capsule 40 mg 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 BetriXa Capsule 40 mg 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.

BetriXa Capsule 40 mg is also used to associated treatment for these conditions: Venous Thromboembolism

How BetriXa Capsule 40 mg works

BetriXa Capsule 40 mg is a cofactor-independent direct inhibitor of the Factor Xa and inhibits free and prothrombinase-bound Factor Xa .

Dosage

BetriXa Capsule 40 mg dosage

The recommended dose of BetriXa Capsule 40 mg 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

BetriXa Capsule 40 mg presents a minimal hepatotoxicity, which is the main adverse effect found in this class of drugs. Some of the major adverse effects of BetriXa Capsule 40 mg 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 BetriXa Capsule 40 mg. Do not administer the next BetriXa Capsule 40 mg dose earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of BetriXa Capsule 40 mg 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 BetriXa Capsule 40 mg.
P-gp Inducers: Decrease the blood level of BetriXa Capsule 40 mg.
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. BetriXa Capsule 40 mg 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.

BetriXa Capsule 40 mg 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

BetriXa Capsule 40 mg Disease Interaction

Major: bleeding, hepatic dysfunction, renal impairment

Volume of Distribution

The apparent volume of distribution os 32 L/kg .

Elimination Route

BetriXa Capsule 40 mg 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 C_max 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

BetriXa Capsule 40 mg presents a long half-life of between 19-27 hours .

Clearance

BetriXa Capsule 40 mg presents a minimal renal clearance (being 5-7% of the administered dose) .

Elimination Route

BetriXa Capsule 40 mg 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 BetriXa Capsule 40 mg 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 BetriXa Capsule 40 mg 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

BetriXa Capsule 40 mg is contraindicated in patients with active pathological bleeding. It is also contraindicated in patients with severe hypersensitivity reaction to BetriXa Capsule 40 mg

Storage Condition

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

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