U.S. Full Prescribing Information Including BOXED WARNINGS

Medication Guide

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Indications

This site is intended for U.S. residents 18 years of age or older.

  • Nonvalvular AFib

    ELIQUIS (apixaban) 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.

  • DVT/PE

    ELIQUIS (apixaban) 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.

  • Hip/Knee Replacement

    ELIQUIS (apixaban) 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.

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U.S. Full Prescribing Information Including BOXED WARNINGS

Indications

  • Nonvalvular AFib

    ELIQUIS (apixaban) 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.

  • DVT/PE

    ELIQUIS (apixaban) 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.

  • Hip/Knee Replacement

    ELIQUIS (apixaban) 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.

Medication Guide

Or Call Us at 1-855-ELIQUIS (354-7847)

Sign up for ELIQUIS 360 Support

Healthcare Professionals Site

En Español

This site is intended for U.S. residents 18 years of age or older.

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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

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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.

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, including 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.

432-US-2400226 08/24