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INDICATIONS

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

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
  • 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 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 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. 1-800-FDA-1088.


Who should not take ELIQUIS?

ELIQUIS is not for patients who:

  • have artificial heart valves
  • have antiphospholipid syndrome (APS),
    especially with positive
    triple antibody testing, who have
    a history of blood clots
  • 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
  • If you have antiphospholipid
    syndrome
  • 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.

Females who are able to become pregnant: talk with your healthcare provider about pregnancy planning, and your risk of severe uterine bleeding if you are treated with blood thinner medicines, including ELIQUIS.

Tell your healthcare team about all the medicines you take, include any:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

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.

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. 1-800-FDA-1088.

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SELECTED 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.