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INDICATIONS
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.
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.
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.
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.
49 out of 2,689 people
had major bleeding
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.
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, inside the abdomen, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.
ELIQUIS offers an alternative to LOVENOX®/warfarin for the treatment of DVT/PE.
SEE ALSO:
Learn More About Treatment With ELIQUIS
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.
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.
96 out of 829 people
had a recurrence
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.
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.
This trial studied major bleeding in people on ELIQUIS and in people on placebo.
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.
4 out of 826 people
had major bleeding
2 out of 840 people
had 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, inside the abdomen, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.
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.
For patients with DVT/PE, ELIQUIS:
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:
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, inside the abdomen, around the heart, in a joint, or in a muscle, leading to damage; or fatal bleeding.
SEE ALSO:
Why Consider 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.
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:
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:
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:
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:
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:
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:
What should I discuss with my healthcare team before starting ELIQUIS?
Talk to your healthcare team about the following:
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:
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.
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
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.
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
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.
ELIQUIS® and the ELIQUIS logo are trademarks of Bristol-Myers Squibb Company.
COUMADIN® is a registered trademark of Bristol-Myers Squibb Pharma Company.
All other trademarks are property of their
respective companies.
© 2020 Bristol-Myers Squibb Company. 432US1903243-01-01 01/20