BETRIXA 40

Betrixaban is approved by the US Food and Drug Administration (FDA) for 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

Factor Xa Inhibitors

Betrixaban 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. Betrixaban inhibits free factor Xa and prothrombinase activity. By directly inhibiting factor Xa, Betrixaban decreases thrombin generation (TG). Betrixaban has no direct effect on platelet aggregation.

Venous Thromboembolism Prevention

Patients hospitalized for acute medical illness at risk for thromboembolic complications

Moderate or severe restricted mobility and other risk factors for VTE: 160 mg PO once initially, THEN 80 mg PO qDay

Recommended duration of treatment: 35-42 days

Dosage Modifications

Coadministration with P-gp inhibitors

Initial single dose of 80 mg, then 40 mg PO qDay x35-42 days

Patients taking P-gp inhibitor who also have severe renal impairment: Not recommended

Renal impairment

Mild-to-moderate (CrCl >30 mL/min): No dose adjustment needed

Severe (CrCl ≥15 to <30 mL/min): Initial single dose of 80 mg, then 40 mg PO qDay x35-42 days

Hepatic impairment

Mild: No dose adjustment required

Moderate-to-severe: Avoid use; these patients may have intrinsic coagulation abnormalities

Dosing Considerations

Limitations of use

Safety and efficacy not established for patients with prosthetic heart valves (not studied)

P-gp Inhibitors: Increase the blood level of Betrixaban. P-gp Inducers: Decrease the blood level of Betrixaban. Anticoagulants, Antiplatelets and Thrombolytics: May increase the risk of bleeding

Betrixaban is contraindicated for use in patients with severe betrixaban hypersensitivity. Betrixaban is contraindicated in patients with active pathological bleeding. Betrixaban increases the risk of bleeding and can cause serious and potentially fatal bleeding.

Contraindicated: Apixaban,Rivaroxaban

For more information contact with your physician.

Easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);

unexpected pain or swelling;

any bleeding that will not stop;

headache, dizziness, weakness, feeling like you might pass out;

urine that looks red, pink, or brown; or

bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effect may include: bleeding.

This is not a complete list. Discuss with physician.

Consider the risks of bleeding and stroke in using this drug in pregnancy. Animal studies showed no embryofetal or teratogenic effects at up to 44 times the human dose, however at the highest doses fetal deaths were seen due to maternal toxicity. There are no controlled data in human pregnancy

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

Discus with Physician