Pronunciation:

be-TRIX-a-ban

Brand Names:

• Bevyxxa

Dosage Forms:

• Capsule

Warnings:

Spinal/Epidural Hematoma: Epidural or spinal hematomas may occur in patients treated with betrixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. The risk of these events may be increased by the use of in-dwelling epidural catheters or concomitant use of medical products affecting hemostasis. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures .

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Factor Xa Inhibitor

Uses of This Medicine:

Betrixaban is used to prevent venous thromboembolism (VTE) in hospitalized patients at risk for blood clots because of the loss or decreased ability to move around or due to other factors.

Betrixaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps prevent harmful clots from forming in the blood vessels.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of betrixaban in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of betrixaban in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Adagrasib
• Alteplase, Recombinant
• Amiodarone
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apalutamide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Atazanavir
• Bemiparin
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Capmatinib
• Carbamazepine
• Carvedilol
• Celecoxib
• Certoparin
• Choline Salicylate
• Cilostazol
• Citalopram
• Clarithromycin
• Clonixin
• Clopidogrel
• Cobicistat
• Conivaptan
• Curcumin
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Defibrotide
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Dronedarone
• Drotrecogin Alfa
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Fosphenytoin
• Heparin
• Ibuprofen
• Iloprost
• Indomethacin
• Inotersen
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Omadacycline
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Parnaparin
• Paroxetine
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piroxicam
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Quinidine
• Ranolazine
• Reviparin
• Rifampin
• Ritonavir
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sarecycline
• Sodium Salicylate
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Telaprevir
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tipranavir
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Treprostinil
• Turmeric
• Urokinase
• Valdecoxib
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Antiphospholipid syndrome or
• Liver disease, moderate or severe—Use is not recommended in patients with these conditions.

• Bleeding, active—Should not be used in patients with these conditions.

• Bleeding problems, history of or
• Catheter insertion in the spine or
• Surgery (eg, spine), recent or history of—Use with caution. The risk of bleeding may be increased.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Prosthetic (artificial) heart valve—Use with caution. Safety and effectiveness has not been established with this population.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take this medicine with food at the same time each day.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For prevention of venous thromboembolism:
    • Adults—At first, a single dose of 160 milligrams (mg). Then your doctor may give you 80 mg once a day for 35 to 42 days.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase the risk of blood clots in the spine or epidural area, which may lead to long-term or permanent paralysis. This is more likely to occur if you have an epidural catheter placed in your back, are taking NSAID or blood clotting medicine, a history of repeated epidural punctures or problems with your spine, or have had surgery on your spine. Tell your doctor right away if you have tingling, numbness, or muscle weakness, especially in your legs and feet.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for several days before having surgery, including dental procedures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding gums

coughing up blood

difficulty in breathing or swallowing

dizziness

headache

increased menstrual flow or vaginal bleeding

nosebleeds

paralysis

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

Less common

Bladder pain

bloody or cloudy urine

blurred vision

decreased urine

difficult, burning, or painful urination

dizziness

dry mouth

frequent urge to urinate

increased thirst

irregular heartbeat

loss of appetite

lower back or side pain

mood changes

muscle pain or cramps

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pounding in the ears

seizures

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Constipation

diarrhea

Incidence not known

Fever

joint or muscle pain

redness and soreness of the eyes

skin rash

sores in the mouth

stomach pain

swelling of the feet or lower legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.