What is the most important information I should know about betrixaban?
Because betrixaban keeps your blood from clotting, this medicine can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have unusual bruising or any bleeding that will not stop.
Tell your doctor about all other medicines you use. Many drugs can further increase your risk of bleeding while you are taking betrixaban.
Betrixaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you have a genetic spinal defect, if you have a spinal catheter in place, if you have a history of spinal surgery or repeated spinal taps, or if you are also using other drugs that can affect blood clotting. This type of blood clot can lead to long-term or permanent paralysis.
Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.
What is betrixaban?
Betrixaban blocks the activity of certain clotting substances in the blood.
Betrixaban is used to prevent blood clots in adults who have a serious illness and decreased ability to move. Blood clots are more likely when you are bedridden and you cannot move around.
Betrixaban may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking betrixaban?
You should not use betrixaban if you are allergic to it, or if you have active or uncontrolled bleeding.
Betrixaban may cause you to bleed more easily, especially if you have kidney disease or you use other medicines such as:
- medicines to treat or prevent blood clots;
- certain antidepressants, antibiotics, antifungal medicines, HIV medicines, or heart rhythm medicines; or
- aspirin or an NSAID (nonsteroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, or meloxicam.
Betrixaban can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:
- you have a genetic spinal defect;
- you have a spinal catheter in place or if a catheter has been recently removed;
- you have had spinal surgery, or repeated spinal taps or epidural anesthesia; or
- you take an NSAID, or use other medicines to treat or prevent blood clots.
To make sure betrixaban is safe for you, tell your doctor if you have ever had:
- liver or kidney disease;
- an artificial heart valve; or
- a bleeding or blood clotting disorder.
It is not known whether this medicine will harm an unborn baby. However, taking this medicine during pregnancy may increase the risk of bleeding while you are pregnant or during your delivery. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether betrixaban passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
How should I take betrixaban?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Betrixaban is usually taken once per day for up to 42 days. Follow your doctor's dosing instructions very carefully.
Because betrixaban keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have unusual bruising, or any bleeding that will not stop.
If you need surgery or dental work, tell the doctor or dentist ahead of time that you take betrixaban. You may need to stop taking the medicine for a short time before you have surgery or other medical procedures.
Do not stop taking betrixaban unless your doctor tells you to. Stopping suddenly can increase your risk of blood clot or stroke.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose may cause excessive bleeding.
What should I avoid while taking betrixaban?
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
What are the possible side effects of betrixaban?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.
Call your doctor at once if you have:
- 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.
Bleeding is the most common side effect of betrixaban.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect betrixaban?
Many other drugs (including some over-the-counter medicines) can increase your risk of bleeding, or your risk of developing blood clots around the brain or spinal cord during a spinal tap or epidural. It is very important to tell your doctor about all medicines you have recently used, especially:
- ketoconazole;
-
an antibiotic --azithromycin, clarithromycin, erythromycin;
-
heart medication --amiodarone, quinidine, verapamil;
-
an antidepressant, such as citalopram, duloxetine, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, venlafaxine, or vilazodone;
-
an NSAID, such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, or meloxicam; or
-
other medicines to treat or prevent blood clots, such as dabigatran, dalteparin, enoxaparin, fondaparinux, heparin, or warfarin (Coumadin, Jantoven).
This list is not complete and many other drugs can interact with betrixaban. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about betrixaban.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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