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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.

ELIQUIS*:

WAS Proven effective to treat
DVT/PE blood clots

Had significantly
less major bleeding

*Versus LOVENOX® followed by warfarin.

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


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.

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IMPORTANT SAFETY INFORMATION & INDICATIONS

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 (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 treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), and reduce the risk of them occurring again.

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.

ELIQUIS is available in 2.5-mg and 5-mg tablets.

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

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.

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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.