Betrixaban

IMPORTANT WARNING:

If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as betrixaban, you are at risk of having a blood clot form in or around your spine that could cause you to become paralyzed. Tell your doctor if you have an epidural catheter that is left in your body or have or have ever had repeated epidural or spinal punctures, spinal deformity, or spinal surgery. Tell your doctor and pharmacist if you are taking 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); and 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); and warfarin (Coumadin, Jantoven). If you experience any of the following symptoms, call your doctor immediately: back pain, muscle weakness, numbness or tingling (especially in your legs and feet), loss of control of your bowels or bladder, or inability to move your legs.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with betrixaban and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk of taking betrixaban.

IMPORTANT NOTICE:

Betrixaban is no longer available in the U.S.

WHY is this medicine prescribed?

Betrixaban is used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; 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 is in a class of medications called factor Xa inhibitors. It works by blocking the action of a certain natural substance that helps blood clots to form.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take betrixaban exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take betrixaban even if you feel well. Do not stop taking betrixaban without talking to your doctor. If you stop taking betrixaban, your risk of a blood clot may increase.

What SPECIAL PRECAUTIONS should I follow?

Before taking betrixaban,

• tell your doctor and pharmacist if you are allergic to betrixaban, any other medications, or any of the ingredients in betrixaban capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, and vitamins you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), and rifampin (Rifadin, Rimactane, in Rifamate, Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with betrixaban, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what nutritional supplements and herbal products you are taking, especially products that contain St. John's wort. Your doctor will probably tell you not to take St. John's wort while taking bextrixaban.

• tell your doctor if you have bleeding anywhere in your body that cannot be stopped. Your doctor will probably tell you not to take betrixaban.

• tell your doctor if you have an artificial heart valve and if you have or have ever had any type of bleeding problem or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking betrixaban, call your doctor.

• call your doctor right away if you fall or injure yourself, especially if you hit your head. Your doctor may need to check you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it on the same day. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Betrixaban may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• diarrhea
• nausea
• frequent or painful urination

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking betrixaban and call your doctor immediately or get emergency medical treatment:

• bleeding gums
• frequent nosebleeds
• menstrual bleeding that is heavier than normal
• red, pink, or brown urine
• red or black, tarry stools
• coughing up blood or blood clots
• vomiting blood or material that looks like coffee grounds
• unexpected pain, swelling, or joint pain
• headache
• dizziness or weakness

Betrixaban prevents blood from clotting normally so it may take longer than usual for you to stop bleeding if you are cut or injured. This medication may also cause you to bruise or bleed more easily. Call your doctor right away if bleeding or bruising is unusual, severe, or cannot be controlled.

Betrixaban may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• bleeding

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.