Generic Name: betrixaban
Dosage Form: Capsules
Date of Approval: June 23, 2017
Company: Portola Pharmaceuticals, Inc.
Treatment for: Prophylaxis of Venous Thromboembolism
FDA Approves Bevyxxa
The U.S. Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban), a factor Xa (FXa) inhibitor for the extended duration prophylaxis of venous thromboembolism (VTE) in at risk adult patients hospitalized for an acute medical illness.
Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Bevyxxa can cause serious side effects, including:
- Bleeding problems. Bevyxxa reduces blood clotting and can increase the risk of bleeding, which can be serious and may lead to death. The risk of bleeding is higher in people who have severe kidney problems (severe renal impairment).
You may have a higher risk of bleeding if you take Bevyxxa and take other medicines that increase your risk of bleeding, including:
- aspirin or aspirin containing products
- long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
- warfarin sodium (Coumadin®, Jantoven®)
- any medicine that contains heparin
- selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
- other medicines to prevent or treat blood clots
- P-glycoprotein (P-gp) inhibitors
While taking Bevyxxa:
- you may bruise more easily
- it may take longer than usual for any bleeding to stop
- unexpected bleeding, or bleeding that lasts a long time such as:
- unusual bleeding from the gums
- nosebleeds that happen often
- menstrual bleeding or vaginal bleeding that is heavier than normal
- bleeding that is severe or you cannot control
- red, pink, or brown urine
- red or black stools (looks like tar)
- cough up blood or blood clots
- vomit blood or your vomit looks like coffee grounds
- unexpected pain, swelling, or joint pain
- headaches, feeling dizzy or weak
- Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like Bevyxxa, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
- a thin tube called an epidural catheter is placed in your back to give you certain medicine
- you take NSAIDs or a medicine to prevent blood from clotting
- you have a history of difficult or repeated epidural or spinal punctures
- you have a history of problems with your spine or have had surgery on your spine
See Bevyxxa side effects for more information about side effects.
What is Bevyxxa?
Bevyxxa is a prescription medicine 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.
- It is not known if Bevyxxa is safe and effective in people with artificial heart valves.
- It is not known if it is safe and effective in children.
Do not take Bevyxxa if you:
- have bleeding problems. Tell your healthcare provider if you have or at risk for bleeding problems.
- are allergic to betrixaban or to any of the other ingredients. See the end of this page for a complete list of ingredients.
Before you start treatment, tell your healthcare provider about all your medical conditions, including if you:
- have liver or kidney problems
- have ever had bleeding problems
- have an artificial heart valve
- are pregnant or plan to become pregnant. It is not known if Bevyxxa will harm your unborn baby. Taking Bevyxxa may increase the risk of bleeding during pregnancy and delivery.
- are breastfeeding or plan to breastfeed. It is not known if Bevyxxa passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.
Tell all of your healthcare providers and dentists that you are taking Bevyxxa. Talk to the healthcare provider who prescribed Bevyxxa for you, before you have any surgery, medical, or dental procedure.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some of your other medicines may affect the way Bevyxxa works. Certain medicines may increase your risk of bleeding when taken with Bevyxxa. See Important information.
How should I take Bevyxxa?
- Take the capsules exactly as prescribed by your healthcare provider.
- Take Bevyxxa one time a day with food.
- Your healthcare provider will decide how long you should receive treatment. Do not change your dose or stop treatment unless your healthcare provider tells you to.
- If you miss a dose, take it as soon as you remember on the same day. Take your next dose at your usual time the next day. Do not take more than one dose at the same time to make up for a missed dose.
- If you take too much or overdose, go to the nearest hospital emergency room or call your healthcare provider right away.
Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you.
Bevyxxa side effects
Bevyxxa can cause serious side effects.
- See Important information
The most common side effect is bleeding.
These are not all of the side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
How should I store Bevyxxa?
- Store the capsules at room temperature between 68°F to 77°F (20°C to 25°C).
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Bevyxxa
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients?
Active ingredient: betrixaban
Inactive ingredients: dextrose monohydrate, croscarmellose sodium, magnesium stearate, and a hard gelatin capsule