U.S. Full Prescribing Information | Medication Guide [Español] | Important Safety Information For Healthcare Professionals

ELIQUIS (apixaban) is a prescription medicine used to reduce the risk of stroke and blood clots
in people who have atrial fibrillation (AFib), a type of irregular heartbeat, not caused by a heart
valve problem.

What is ELIQUIS?

ELIQUIS (apixaban) is a prescription blood thinner used to reduce the risk of stroke and blood-clots in people who have atrial fibrillation (AFib), a type of irregular heartbeat, not caused by a heart valve problem. This type of irregular heartbeat can cause blood clots to form, which may lead to a stroke.

ELIQUIS can play an important role for people with AFib not caused by a heart valve problem. While ELIQUIS can't regulate your irregular heartbeat or treat symptoms, it can reduce the risk of stroke by helping to prevent clots from forming.

Selected Important Safety Information

Do not stop taking ELIQUIS without talking to the doctor who prescribed it for you. Stopping ELIQUIS increases your risk of having a stroke.
ELIQUIS may need to be stopped prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking ELIQUIS and when you may start taking it again. If you have to stop taking ELIQUIS, your doctor may prescribe another medicine to help prevent a blood clot from forming.

ELIQUIS can cause bleeding, which can be serious, and rarely may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood clotting.

Please read additional Important Safety Information and ELIQUIS Indication below.

How does ELIQUIS work?

ELIQUIS works by blocking Factor Xa, which is a blood-clotting factor critical to the blood-clotting process. By blocking Factor Xa, ELIQUIS lowers the chance of blood clots forming and decreases the risk of having a stroke in people with atrial fibrillation not caused by a heart valve problem.

ELIQUIS is supported by extensive cinical research

ELIQUIS was studied in 2 clinical trials to evaluate stroke risk due to AFib not caused by a heart valve problem. Approximately 24,000 people participated in the 2 studies, including more than 11,000 people who took ELIQUIS.

The first trial compared ELIQUIS to warfarin in people with AFib not caused by a heart valve problem and who had at least one additional risk factor for stroke. The second trial compared ELIQUIS to aspirin in people with AFib not caused by a heart valve problem who were not suitable for warfarin treatment and who had at least one additional risk factor for stroke.

As a result of these clinical trials, ELIQUIS was approved to reduce the risk of stroke and blood clots in people with AFib not caused by a heart valve problem.

Next: Reasons to Rethink Warfarin

IMPORTANT SAFETY INFORMATION
  • For people taking ELIQUIS® (apixaban) for atrial fibrillation: Do not stop taking ELIQUIS without talking to the doctor who prescribed it for you. Stopping ELIQUIS increases your risk of having a stroke.
    ELIQUIS may need to be stopped prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking ELIQUIS and when you may start taking it again. If you have to stop taking ELIQUIS, your doctor may prescribe another medicine to help prevent a blood clot from forming.
  • ELIQUIS can cause bleeding, which can be serious, and rarely may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood-clotting.
  • You may have a higher risk of bleeding if you take ELIQUIS and take other medicines that increase your risk of bleeding, such as aspirin, nonsteroidal anti-inflammatory drugs (called NSAIDs), warfarin (COUMADIN®), heparin, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and other medicines to help prevent or treat blood clots. Tell your doctor about all of the medicines you take, including any over-the-counter medicines, vitamins, and herbal supplements.
    While taking ELIQUIS, you may bruise more easily and it may take longer than usual for any bleeding to stop.
  • Call your doctor or get medical help right away if you have any of these signs or symptoms of bleeding when taking ELIQUIS:
    • unexpected bleeding or bleeding that lasts a long time, such as unusual bleeding from the gums, nosebleeds that happen often, or menstrual 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)
    • coughing up or vomiting blood or vomit that looks like coffee grounds
    • unexpected pain, swelling, or joint pain
    • headaches, or feeling dizzy or weak
  • ELIQUIS (apixaban) is not for patients with artificial heart valves.
  • Spinal or epidural blood clots or bleeding (hematoma). People who take ELIQUIS, 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
  • If you take ELIQUIS and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots or bleeding. Tell your doctor right away if you have tingling, numbness, or muscle weakness, especially in your legs and feet.
  • Do not take ELIQUIS if you currently have certain types of abnormal bleeding or have had a serious allergic reaction to ELIQUIS.
  • Before you take ELIQUIS, tell your doctor if you have kidney or liver problems, have any other medical condition, or have ever had bleeding problems. Tell your doctor if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. You and your doctor should decide if you will take ELIQUIS or breastfeed. You should not do both.
  • Take ELIQUIS exactly as prescribed by your doctor. Take ELIQUIS twice every day with or without food, and do not change your dose or stop taking it unless your doctor tells you to. If you miss a dose of ELIQUIS, take it as soon as you remember, and do not take more than one dose at the same time. If you are taking ELIQUIS for atrial fibrillation, stopping ELIQUIS may increase your risk of having a stroke. Do not run out of ELIQUIS. Refill your prescription before you run out. When leaving the hospital following hip or knee replacement, be sure that you will have ELIQUIS available to avoid missing any doses.
  • Possible serious side effects include bleeding or a reaction to ELIQUIS itself. A reaction to ELIQUIS can cause hives, rash, itching, and possibly trouble breathing. If you get this reaction, it will usually happen soon after you take a dose of ELIQUIS. Get medical help right away if you have sudden chest pain or chest tightness, have sudden swelling of your face or tongue, have trouble breathing, wheezing, or feeling dizzy or faint.

INDICATIONS

ELIQUIS (apixaban) is a prescription medicine used to reduce the risk of stroke and blood clots in people who have atrial fibrillation, a type of irregular heartbeat, not caused by a heart valve problem.

ELIQUIS is a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.

Please see U.S. Full Prescribing Information, including Boxed WARNINGS and Medication Guide.

COUMADIN® is a registered trademark of Bristol-Myers Squibb Company. All other trademarks are property of their respective companies.

This independent, non-profit organization provides assistance to qualifying patients with financial hardship who generally have no prescription insurance.
Contact 1-800-736-0003 or visit www.bmspaf.org for more information.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

IMPORTANT SAFETY INFORMATION SEE MORE +
  • For people taking ELIQUIS® (apixaban) for atrial fibrillation: Do not stop taking ELIQUIS without talking to the doctor who prescribed it for you. Stopping ELIQUIS increases your risk of having a stroke.
    ELIQUIS may need to be stopped prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking ELIQUIS and when you may start taking it again. If you have to stop taking ELIQUIS, your doctor may prescribe another medicine to help prevent a blood clot from forming.
  • ELIQUIS can cause bleeding, which can be serious, and rarely may lead to death. This is because ELIQUIS is a blood thinner medicine that reduces blood-clotting.
  • You may have a higher risk of bleeding if you take ELIQUIS and take other medicines that increase your risk of bleeding, such as aspirin, nonsteroidal anti-inflammatory drugs (called NSAIDs), warfarin (COUMADIN®), heparin, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and other medicines to help prevent or treat blood clots. Tell your doctor about all of the medicines you take, including any over-the-counter medicines, vitamins, and herbal supplements.
    While taking ELIQUIS, you may bruise more easily and it may take longer than usual for any bleeding to stop.
  • Call your doctor or get medical help right away if you have any of these signs or symptoms of bleeding when taking ELIQUIS:
    • unexpected bleeding or bleeding that lasts a long time, such as unusual bleeding from the gums, nosebleeds that happen often, or menstrual 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)
    • coughing up or vomiting blood or vomit that looks like coffee grounds
    • unexpected pain, swelling, or joint pain
    • headaches, or feeling dizzy or weak
  • ELIQUIS (apixaban) is not for patients with artificial heart valves.
  • Spinal or epidural blood clots or bleeding (hematoma). People who take ELIQUIS, 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
  • If you take ELIQUIS and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots or bleeding. Tell your doctor right away if you have tingling, numbness, or muscle weakness, especially in your legs and feet.
  • Do not take ELIQUIS if you currently have certain types of abnormal bleeding or have had a serious allergic reaction to ELIQUIS.
  • Before you take ELIQUIS, tell your doctor if you have kidney or liver problems, have any other medical condition, or have ever had bleeding problems. Tell your doctor if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. You and your doctor should decide if you will take ELIQUIS or breastfeed. You should not do both.
  • Take ELIQUIS exactly as prescribed by your doctor. Take ELIQUIS twice every day with or without food, and do not change your dose or stop taking it unless your doctor tells you to. If you miss a dose of ELIQUIS, take it as soon as you remember, and do not take more than one dose at the same time. If you are taking ELIQUIS for atrial fibrillation, stopping ELIQUIS may increase your risk of having a stroke. Do not run out of ELIQUIS. Refill your prescription before you run out. When leaving the hospital following hip or knee replacement, be sure that you will have ELIQUIS available to avoid missing any doses.
  • Possible serious side effects include bleeding or a reaction to ELIQUIS itself. A reaction to ELIQUIS can cause hives, rash, itching, and possibly trouble breathing. If you get this reaction, it will usually happen soon after you take a dose of ELIQUIS. Get medical help right away if you have sudden chest pain or chest tightness, have sudden swelling of your face or tongue, have trouble breathing, wheezing, or feeling dizzy or faint.

INDICATIONS

ELIQUIS (apixaban) is a prescription medicine used to reduce the risk of stroke and blood clots in people who have atrial fibrillation, a type of irregular heartbeat, not caused by a heart valve problem.

ELIQUIS is a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.

Please see U.S. Full Prescribing Information, including Boxed WARNINGS and Medication Guide.

COUMADIN® is a registered trademark of Bristol-Myers Squibb Company. All other trademarks are property of their respective companies.

This independent, non-profit organization provides assistance to qualifying patients with financial hardship who generally have no prescription insurance.
Contact 1-800-736-0003 or visit www.bmspaf.org for more information.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.