Betrixaban

What is Betrixaban?

• Betrixaban (Bevyxxa) is a factor Xa (FXa) inhibitor used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (a blood clot in the lung) in people who are hospitalized for serious illnesses and are at risk of developing a clot due to decreased ability to move around or other risk factors.

Betrixaban

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Betrixaban structure

What are the uses of this medicine?

• Betrixaban (Bevyxxa) is used to help prevent blood clots in adults who are hospitalized for an acute illness, and are at risk of getting blood clots because of the loss of or decreased ability to move around (mobility) and other risks for getting blood clots.

Limitations of use:

• It is not known if Bevyxxa is safe and effective in people with artificial heart valves.
• It is not known if Bevyxxa is safe and effective in children.

How does this medicine work?

• Betrixaban is an oral FXa inhibitor that selectively blocks the active site of FXa and does not require a cofactor (such as Antithrombin 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• have bleeding problems
• are allergic to betrixaban or to any of the ingredients in Bevyxxa

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the following:

• amiodarone (Pacerone, Nexterone)
• anagrelide (Agrylin)
• aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others)
• azithromycin (Zithromax, Zmax)
• cilostazol (Pletal)
• clarithromycin (Biaxin, in Prevpac)
• clopidogrel (Plavix)
• dipyridamole (Persantine)
• eptifibatide (Integrilin)
• heparin
• ketoconazole (Nizoral, Extina)
• prasugrel (Effient)
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), luvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft)
• serotonin and norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), levomilnacipran (Fetzima), milnacipran (Savella), and venlafaxine (Effexor)
• ticagrelor (Brilinta)
• ticlopidine
• tirofiban (Aggrastat)
• verapamil (Verelan, Calan)
• warfarin (Coumadin, Jantoven)
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• phenytoin (Dilantin, Phenytek)
• rifampin (Rifadin, Rimactane, in Rifamate, Rifater)
• St. John's wort

Is this medicine FDA approved?

• Betrixaban was approved by FDA on June 23, 2017, becoming the first DOAC approved for extended prophylaxis in hospitalized patients.

How should this medicine be used?

Recommended 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.

Use with P-gp Inhibitors:

• For patients receiving or starting concomitant P-gp inhibitors, the recommended dose of Bevyxxa is an initial single dose of 80 mg, followed by 40 mg once daily.

Patients with Severe Renal Impairment:

• For patients with severe renal impairment, the recommended dose of Bevyxxa is an initial single dose of 80 mg, followed by 40 mg once daily.

Patients with Hepatic Impairment:

• Avoid use of Bevyxxa in patients with moderate or severe hepatic impairment.

Administration:

• Betrixaban comes as a capsule to take by mouth.
• It is usually taken with food once a day for 35 to 42 days.
• Take betrixaban at around the same time every day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 40 mg and 80 mg

This medicine is available in fallowing brand namesː

• Bevyxxa

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• diarrhea
• nausea
• frequent or painful urination

Bevyxxa can cause serious side effects, including:

• Bleeding problems
• hematoma

What special precautions should I follow?

• Bevyxxa increases the risk of bleeding and can cause serious and potentially fatal bleeding. Advise patients of signs and symptoms of blood loss and to report them immediately and seek emergency care. Promptly evaluate any signs or symptoms of blood loss, and consider the need for blood replacement. Discontinue Bevyxxa in patients with active pathological bleeding.
• Patients with severe renal impairment taking Bevyxxa may have an increased risk of bleeding events. Reduce dose of Bevyxxa, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients.
• Patients on concomitant P-gp inhibitors with Bevyxxa may have an increased risk of bleeding. Reduce dose of Bevyxxa in patients receiving or starting P-gp inhibitors. Avoid use of Bevyxxa in patients with severe renal impairment receiving concomitant P-gp inhibitors.
• Direct-acting oral anticoagulants (DOACs), including Bevyxxa, are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS).

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• risk of bleeding

Management of overdosage:

• A specific reversal agent for Bevyxxa is not available.
• There is no experience with hemodialysis in individuals receiving betrixaban.
• Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of betrixaban.

Can this medicine be used 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.
• Bevyxxa should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: betrixaban
• Inactive ingredients: dextrose monohydrate, croscarmellose sodium, magnesium stearate, and a hard gelatin capsule

Who manufactures and distributes this medicine?

Manufactured for:

• Portola Pharmaceuticals LLC, South San Francisco, California USA

What should I know about storage and disposal of this medication?

• Store Bevyxxa at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Betrixaban
• FDA Betrixaban

Betrixaban Resources
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Betrixaban Resources
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