betrixaban (Rx)

Brand and Other Names:Bevyxxa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 40mg
  • 80mg

Venous Thromboembolism Prevention

Indicated for prophylaxis of venous thromboembolism (VTE) in adults hospitalized for acute medical illness who are at risk for thromboembolic complications owing to moderate or severe restricted mobility and other risk factors for VTE

Initial single dose: 160 mg PO, 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)

Safety and efficacy not established

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Interactions

Interaction Checker

and betrixaban

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Clinically relevant nonmajor bleeding (2.45%)

            Epistaxis (2%)

            Hematuria (2%)

            <1%

            Bleeding

            • Major bleeding (0.67%)
            • GI bleeding (0.51%)
            • Intracranial hemorrhage (0.05%)
            • Fatal bleeding (0.03%)
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            Warnings

            Black Box Warnings

            Spinal/epidural hematoma

            • Epidural or spinal hematomas may occur in patients who are receiving neuraxial anesthesia or undergoing spinal puncture
            • These hematomas may result in long-term or permanent paralysis
            • Monitor patients frequently for signs and symptoms of neurological impairment (eg, numbness or weakness of legs, bowel, or bladder); if neurological compromise is noted, urgent treatment is necessary
            • Consider the benefits and risks before neuraxial intervention in patients who are anticoagulated or to be anticoagulated
            • Management
              • Do not remove an epidural catheter earlier than 72 hr after the last administration of betrixaban
              • Do not administer the next betrixaban dose earlier than 5 hr after catheter removal
              • If traumatic puncture occurs, delay administering betrixaban for 72 hr
            • Factors that can increase the risk include
              • Use of indwelling epidural catheters
              • Concomitant use of other drugs that affect hemostasis (eg, NSAIDs, platelet inhibitors, other anticoagulants)
              • History of traumatic or repeated epidural or spinal punctures
              • History of spinal deformity or spinal surgery
              • Optimal timing between the administration of drug and neuraxial procedures is not known

            Contraindications

            Active pathological bleeding

            Severe hypersensitivity

            Cautions

            Increases bleeding risk and can cause serious and potentially fatal bleeding; promptly evaluate any signs or symptoms of blood loss; there is no established way to reverse betrixaban’s anticoagulant effect, which can persist for at least 72 hr after the last dose; protamine, vitamin K, and tranexamic acid are not expected to reverse betrixaban anticoagulant activity

            Risk of paralysis with neuraxial anesthesia (see Black Box Warnings)

            Increased bleeding risk with severe renal impairment (see Dosage Modifications)

            Drug interaction overview

            • P-gp substrate
            • Reduce betrixaban dose if coadministration with P-gp inhibitors, owing to increased bleeding risk; avoid coadministration in patients with severe renal impairment receiving concomitant P-gp inhibitors
            • Avoid coadministration with P-gp inducers owing to potential for decreased systemic exposure and pharmacodynamic effects of betrixaban
            • Coadministration with drugs affecting hemostasis increases bleeding risk; examples include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs
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            Pregnancy

            Pregnancy

            No data exist with use in pregnant women, but treatment is likely to increase risk of hemorrhage during pregnancy and delivery

            Use during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus

            Animal studies

            • Although betrixaban has not been associated with adverse developmental fetal outcomes in animals, maternal toxicity (ie, hemorrhage) was identified in these studies

            Lactation

            Unknown if distributed in human breast milk

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Oral factor Xa (FXa) inhibitor that selectively blocks the active site of FXa and does not require a cofactor (eg, antithrombin III) for activity; inhibits free FXa and prothrombinase activity

            By directly inhibiting FXa, betrixaban decreases thrombin generation

            Has no direct effect on platelet aggregation

            Blood coagulation cascade is dependent upon the activation of factor X to FXa via the intrinsic and extrinsic pathways, which play a central role in the blood coagulation cascade

            Absorption

            Bioavailability: 34%

            Peak plasma time: 3-4 hr

            Distribution

            Protein bound: 60%

            Vd: 32 L/kg

            Metabolism

            Unchanged betrixaban is the predominant component found in human plasma

            Two inactive major metabolites formed by CYP-independent hydrolysis comprise the other components in plasma, accounting for 15-18% of the circulating drug-related material

            Elimination

            Half-life: 19-27 hr

            Excretion: 85% feces; 11% urine

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            Administration

            Oral Administration

            Take with food at approximately the same time each day

            Missed dose: Take as soon as possible on the same day; do not double dosage to make up for a missed dose

            Storage

            Store at room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.