Yudu - 2015 02 February

IMPORTANT FACTS about ELIQUIS® (apixaban) tablets

The information below does not take the place of talking with your healthcare professional. Only your healthcare professional knows the specifics of your condition and how ELIQUIS may fit into your overall therapy. Talk to your healthcare professional if you have any questions about ELIQUIS (pronounced ELL eh kwiss).

What is the most important information I should know about ELIQUIS (apixaban)?

For people taking ELIQUIS 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®

selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and other medicines to help prevent or treat blood clots.

), heparin,

Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

While taking ELIQUIS: • you may bruise more easily •

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

• menstrual bleeding or vaginal bleeding that is heavier than normal

• red, pink, or brown urine •

bleeding that is severe or you cannot control red or black stools (looks like tar)

• cough up blood or blood clots

• vomit blood or your vomit looks like coffee grounds

• unexpected pain, swelling, or joint pain • headaches, feeling dizzy or weak

ELIQUIS is not for patients with artificial heart valves.

Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like 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 (apixaban) 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.

What is ELIQUIS? ELIQUIS is a prescription medicine used to:

• reduce the risk of stroke and blood clots in people who have atrial fibrillation.

• •

reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.

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

It is not known if ELIQUIS is safe and effective in children.

Who should not take ELIQUIS? Do not take ELIQUIS if you: •

currently have certain types of abnormal bleeding

• have had a serious allergic reaction to ELIQUIS. Ask your doctor if you are not sure

What should I tell my doctor before taking ELIQUIS? Before you take ELIQUIS, tell your doctor if you: • have kidney or liver problems

• have any other medical condition • have ever had bleeding problems •

•

are pregnant or plan to become pregnant. It is not known if ELIQUIS will harm your unborn baby

are breastfeeding or plan to breastfeed. It is not known if ELIQUIS passes into your breast milk. You and your doctor should decide if you will take ELIQUIS or breastfeed. You should not do both

Tell all of your doctors and dentists that you are taking ELIQUIS. They should talk to the doctor who prescribed ELIQUIS for you, before you have any surgery, medical or dental procedure.

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.

Tell your doctor about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way ELIQUIS (apixaban) works. Certain medicines may increase your risk of bleeding or stroke when taken with ELIQUIS.

How should I take ELIQUIS?

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. 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. If you are taking ELIQUIS for atrial fibrillation, stopping ELIQUIS may increase your risk of having a stroke.

What are the possible side effects of ELIQUIS?

• See “What is the most important information I should know about ELIQUIS?”

• ELIQUIS can cause a skin rash or severe allergic reaction. Call your doctor or get medical help right away if you have any of the following symptoms:

• • • •

chest pain or tightness

swelling of your face or tongue trouble breathing or wheezing feeling dizzy or faint

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of ELIQUIS. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This is a brief summary of the most important information about ELIQUIS. For more information, talk with your doctor or pharmacist, call 1-855-ELIQUIS (1-855-354-7847), or go to www.ELIQUIS.com.

Manufactured by: Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA Marketed by: Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA and Pfizer Inc New York, New York 10017 USA

COUMADIN® is a trademark of Bristol-Myers Squibb Pharma Company.

Based on 1289808A1 / 1289807A1 / 1298500A1 / 1295958A1 August 2014

432US14BR00770-07-01