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INDICATIONS

Clinical Trials

ELIQUIS Was Studied in the Following 2 Clinical Trials

Clinical trial results are important because they can help doctors consider and choose the right treatment for you based on their efficacy and safety results.

ELIQUIS Was Proven to Treat DVT/PE

In a clinical trial, ELIQUIS was tested against LOVENOX® (enoxaparin) followed by warfarin (LOVENOX®/warfarin), a standard treatment, for the first 6 months after DVT/PE.

This trial included more than 5,200 people who had DVT/PE—about half were on LOVENOX®/warfarin and the other half were on ELIQUIS.

Clinical Trial Efficacy Results—DVT/PE

2.7% of the people on LOVENOX®/warfarin and 2.3% of the people on ELIQUIS had a DVT/PE clot. These results are considered comparable.

In this trial, bleeding events were also compared.

Clinical Trial Safety Results—
Major Bleeding

In the trial, those who were on ELIQUIS had significantly less major bleeding compared to those who were on LOVENOX®/warfarin. 1.8% of the people on LOVENOX®/warfarin and 0.6% of the people on ELIQUIS had major bleeding.

On LOVENOX®/warfarin

1.8%

49 out of 2,689 people
had major bleeding

On ELIQUIS

0.6%

15 out of 2,676 people
had major bleeding

ELIQUIS and other blood thinners increase the risk of bleeding, which can be serious, and rarely may lead to death.

Absolute reduction was 1.2% (1.8% – 0.6% = 1.2%). Relative risk reduction was 69%, which means that people on ELIQUIS had 69% less chance of major bleeding than people on LOVENOX®/warfarin.

What is major bleeding?

Major bleeding included noticeable bleeding with at least 1 of the following—a transfusion of 2 or more units of blood; bleeding that occurred in the brain, spine, eye, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.

Trial outcome

ELIQUIS offers an alternative to LOVENOX®/warfarin for the treatment of DVT/PE.


SEE ALSO:
Learn More About Treatment With ELIQUIS


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In a Second Trial, ELIQUIS Significantly Reduced the Risk of Another DVT/PE After Initial Treatment

This trial evaluated ELIQUIS versus placebo in more than 1,600 people for reducing the risk of a DVT/PE happening again. It looked at the effects of treating people with ELIQUIS for an additional 12 months after they had completed their initial 6-12 month treatment for DVT/PE with a blood thinner. In this trial, there were a similar number of people on ELIQUIS compared to placebo. 829 people were taking placebo; 840 were taking 2.5 mg ELIQUIS twice a day.

Versus placebo.

Clinical Trial Results—DVT/PE Efficacy

Those who took ELIQUIS to reduce the risk of recurrence had less chance of having another DVT/PE clot compared to placebo.

In this trial, there were a similar number of people on ELIQUIS compared to placebo. 11.6% of those on placebo and 3.8% of those on ELIQUIS 2.5 mg twice a day had a recurrence of DVT/PE.

On placebo

11.6%

96 out of 829 people
had a recurrence

On ELIQUIS

3.8%

32 out of 840 people
had a recurrence

Absolute reduction was 7.8% (11.6% – 3.8% = 7.8%). Relative risk reduction was 67%, which means that people on ELIQUIS had 67% less chance of DVT/PE recurrence than people on placebo.

What is a placebo?

A placebo is a pill that contains no medicine. It’s sometimes called a sugar pill. In “double-blind” clinical trials—like this one for ELIQUIS—neither the patients nor the doctors conducting the trials know who is given placebo and who is given the actual medicine—the pills look the same.

Major bleeding was also studied

This trial studied major bleeding in people on ELIQUIS and in people on placebo.

Clinical trial results—major bleeding

In the trial, 0.5% (or 4 people) of the 826 people on placebo and 0.2% (or 2 people) of the 840 people on ELIQUIS had major bleeding.

On placebo

0.5%

4 out of 826 people
had major bleeding

On ELIQUIS

0.2%

2 out of 840 people
had major bleeding

What is major bleeding?

Major bleeding included noticeable bleeding with at least 1 of the following—a transfusion of 2 or more units of blood; bleeding that occurred in the brain, spine, eye, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.

Trial outcome

In this study, ELIQUIS significantly reduced the risk of having another DVT/PE after initial treatment versus placebo.

ELIQUIS and other blood thinners increase the risk of bleeding, which can be serious, and rarely may lead to death.


ELIQUIS is FDA-approved

For patients with DVT/PE, ELIQUIS

Treats and helps
prevent another DVT/PE

Has significantly
less major bleeding

Treated DVT/PE blood clots and had less major bleeding in a 6-month study vs. LOVENOX® (enoxaparin) followed by warfarin.

Helped prevent another DVT/PE in a separate 12-month study vs. placebo.

ELIQUIS and other blood thinners increase the risk of bleeding, which can be serious, and rarely may lead to death.

In the 6-month study vs. LOVENOX® followed by warfarin:

Almost 98% of patients on ELIQUIS didn’t experience another DVT/PE blood clot.

What is major bleeding?

Major bleeding included noticeable bleeding with at least 1 of the following—a transfusion of 2 or more units of blood; bleeding that occurred in the brain, spine, eye, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.


SEE ALSO:
Why Consider ELIQUIS


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Important facts about
ELIQUIS® (apixaban)& INDICATIONS: This is a summary of important information that you need to know about ELIQUIS.

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.

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

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

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.