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INDICATIONS

AFib & Stroke Risk
What Is Nonvalvular AFib?

There are 2 types of atrial fibrillation (AFib): one that is caused by a heart valve problem, and one that is not. Most cases of AFib are not caused by a heart valve problem. AFib not caused by a heart valve problem means the same thing as “nonvalvular atrial fibrillation,” or NVAF, which was estimated to affect approximately 6.4 million people in the U.S. in 2014.


SEE ALSO:
What Are Some Symptoms of AFib?


What Is Happening In My Heart?

Try to picture your heart as a soft squeeze bottle filled with liquid.

Now imagine pressing very quickly but lightly.
You never get all the liquid out the way you would with a full squeeze.

Similarly, in the heart, this can allow blood to pool in the atria, the top chambers of the heart.

If you have AFib, the top 2 chambers of your heart, the atria, quiver (fibrillate) instead of contracting with a full squeeze. Because of this, the atria do not push all the blood out to where it should go, the ventricles, which are the lower 2 chambers of your heart.

The blood left in the atria can pool and clump together, increasing the risk for clots to form. If a clot breaks loose and travels to the brain, blocking or limiting blood flow, it can cause a stroke.

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What Are Some Risks With AFib?

GREATER RISK OF STROKE

People who have AFib not caused by a heart valve problem are at 5 times greater risk of suffering a stroke. So it’s important to ask your doctor about treatment options that can help reduce the risk of stroke.

Watch this animation for a better understanding of the steps that may lead to a stroke:

HOW A CLOT IN THE HEART MAY LEAD TO A STROKE IN THE BRAIN

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What Are Some Signs and Symptoms of a Stroke?

Learn the signs of a stroke—and act fast

If you or someone you know has AFib, make sure you know the signs of stroke really well—knowing these can help you act fast and get immediate medical attention.

Remember, stroke is a medical emergency. If you notice any of the signs listed below, call 9-1-1 immediately.
Sudden numbness or weakness of the face, arm, or leg, especially on one side of the body
Sudden droopiness around the mouth while trying to smile
Sudden change in vision: blurred, blackened, or double vision in one or both eyes
Sudden headache with or without vomiting and dizziness
Sudden loss of balance or coordination
Sudden trouble with speaking or understanding speech

Note the time when the signs first begin. This information is important for your doctor to know.

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What Blood Thinner Options
Are Available?

When you learn that you have AFib not caused by a heart valve problem, your next question may be: so what can I do to help decrease the risk of stroke? Fortunately, there are treatments available. Doctors often prescribe blood thinners to reduce the risk of blood clots and stroke due to AFib not caused by a heart valve problem.

Choosing a Blood Thinner with your doctor

For more than 60 years, people with AFib were prescribed a blood thinner called warfarin. These days, you have more choices. Working with your doctor is the first step in finding out if stroke risk reduction treatment with ELIQUIS is a better option for you than warfarin.

can help you get the answers you need.


SEE ALSO:
How ELIQUIS May Help


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Important facts about
ELIQUIS® (apixaban) & INDICATIONS

This is a summary of important information that you need to know about ELIQUIS. Keep this document in a safe place, so you can refer to it before and during your treatment.

  • Look out for the following icons as you read:
  • Talk to your healthcare team
  • Call a healthcare provider right away
  • Helpful information to remember

Do not stop taking ELIQUIS without talking to the doctor who prescribed it to you
For patients taking ELIQUIS for atrial fibrillation: stopping ELIQUIS increases your risk of having a stroke.

Talk to your healthcare team before any medical procedures. ELIQUIS may need to be stopped before 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.


What are the possible serious side effects of ELIQUIS?
This is a list of some of the serious side effects of ELIQUIS.

Bleeding

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. While taking ELIQUIS, you may bruise more easily and it may take longer than usual for any bleeding to stop.

You may have a higher risk of bleeding if you take ELIQUIS with 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)
  • Other medicines to help prevent or treat blood clots

Tell your doctor if you take any of these medicines.

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
    • 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
  • Vomit that looks like coffee grounds
  • Unexpected pain, swelling, or joint pain
  • Headaches
  • Feeling dizzy or weak

Spinal or epidural blood clots (hematoma)

People who take ELIQUIS, and have medicine injected into their spinal or 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 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 any of these signs or symptoms (especially in your legs and feet) when taking ELIQUIS:

  • Tingling
  • Numbness
  • Muscle weakness

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 any of the following symptoms:

  • Sudden chest pain or chest tightness
  • Sudden swelling of your face or tongue
  • Trouble breathing
  • Wheezing
  • Feeling dizzy or faint

Talk to your doctor about any side effect that may be bothering you or that does not go away. These are not all of the possible side effects of ELIQUIS. Call your doctor for medical advice about side effects.

You are encouraged to report any side effects to the FDA at 1-800-FDA-1088.


Who should not take ELIQUIS?

ELIQUIS is not for patients who:

  • have artificial heart valves.
  • currently have certain types of abnormal bleeding.
  • have had a serious
    allergic
    reaction to ELIQUIS.

What should I discuss with my healthcare team before starting ELIQUIS?

Talk to your healthcare team about the following:

  • Kidney or liver problems
  • Any other medical conditions
  • If you have ever had bleeding problems

Tell your doctor if you are pregnant or breastfeeding, or planning to become pregnant or breastfeed. You and your doctor should decide if you will take ELIQUIS or breastfeed. You should not do both.

Tell your healthcare team about all of the medications you are taking, including:

  • Prescriptions
  • Over-the-counter medicines
  • Herbal supplements
  • Vitamins

During treatment, make sure you talk to your healthcare team before you begin to take any new medication.


How should I take ELIQUIS?

Take ELIQUIS exactly as prescribed by your doctor.

Twice daily
With or without food

Do not change your dose or stop taking ELIQUIS unless your doctor tells you to.

What if I miss a dose of ELIQUIS?

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.

When should I refill my prescription?

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.

ELIQUIS is available in two different tablets. Your doctor or healthcare provider will determine what dose is right for you.

2.5 mg tablet

Round, with a pale yellow color

OR

5 mg tablet

Oval, with a pale orange or pink color

Note: Images do not represent actual tablet size.

On one side of each tablet, there is a number indicating the dosage strength of the tablet (in milligrams). On the other side, there is a medication identification number.


What is ELIQUIS?
ELIQUIS 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.

Treat blood clots in the veins of the legs (deep vein thrombosis – DVT) or lungs
(pulmonary embolism – PE), and reduce

the risk of them occurring again.

Reduce the risk of forming a blood clot in the legs (DVT) and lungs (PE) of people
who have just had hip or knee replacement surgery.

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

LOVENOX® is a registered trademark of Aventis Pharma S.A.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

432US1703386-01-01  12/17

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SELECTED 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.