Apixaban

IMPORTANT WARNING:

If you have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) and are taking apixaban to help prevent strokes or serious blood clots, you are at a higher risk of having a stroke after you stop taking this medication. Do not stop taking apixaban without talking to your doctor. Continue to take apixaban even if you feel well. Be sure to refill your prescription before you run out of medication so that you will not miss any doses of apixaban. If you need to stop taking apixaban, your doctor may prescribe another anticoagulant ('blood thinner') to help prevent a blood clot from forming and causing you to have a stroke.

If you have epidural or spinal anesthesia or a spinal puncture while taking a 'blood thinner' such as apixaban, you are at risk of having a blood clot form in or around your spine that could cause you to become paralyzed. Tell your doctor if you have an epidural catheter that is left in your body or have or have ever had repeated epidural or spinal punctures, spinal deformity, or spinal surgery. Tell your doctor and pharmacist if you are taking any of the following: anagrelide (Agrylin); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others); cilostazol (Pletal); clopidogrel (Plavix); dipyridamole (Persantine); eptifibatide (Integrilin); heparin; prasugrel (Effient); ticagrelor (Brilinta); ticlopidine; tirofiban (Aggrastat), and warfarin (Coumadin, Jantoven). If you experience any of the following symptoms, call your doctor immediately: muscle weakness (especially in your legs and feet), numbness or tingling (especially in your legs), or loss of control of your bowels or bladder.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with apixaban and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking apixaban.

WHY is this medicine prescribed?

Apixaban is used to help prevent strokes or blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body and possibly causing strokes) that is not caused by heart valve disease. Apixaban is also used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in people who are having hip replacement or knee replacement surgery. Apixaban is also used to treat DVT and PE and may be continued to prevent DVT and PE from happening again after the initial treatment is completed. Apixaban is in a class of medications called factor Xa inhibitors. It works by blocking the action of a certain natural substance that helps blood clots to form.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Apixaban comes as a tablet to take by mouth. It is usually taken with or without food twice a day. When apixaban is taken to prevent DVT and PE after hip or knee replacement surgery, the first dose should be taken at least 12 to 24 hours after surgery. Apixaban is usually taken for 35 days after a hip replacement surgery and for 12 days after knee replacement surgery. Take apixaban at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take apixaban exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are unable to swallow the tablets, you can crush them and mix with water, apple juice, or applesauce. Swallow the mixture right after you prepare it. Apixaban can also be given in certain types of feeding tubes. Ask your doctor if you should take this medication in your feeding tube. Follow your doctor's directions carefully.

Continue to take apixaban even if you feel well. Do not stop taking apixaban without talking to your doctor. If you stop taking apixaban, your risk of a blood clot may increase.

What SPECIAL PRECAUTIONS should I follow?

Before taking apixaban,

• tell your doctor and pharmacist if you are allergic to apixaban, any other medications, or any of the ingredients in apixaban tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking apixaban. Your doctor may need to change the doses of your medications or monitor you carefully for side effects..

• The following nonprescription or herbal products may interact with apixaban: St. John's wort; aspirin; NSAIDs (such as ibuprofen [Advil, Motrin] and naproxen [Aleve, Naprosyn]). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking apixaban. Do not start any of these medications while taking apixaban without discussing with your healthcare provider.

• you should know that apixaban may interact with certain medications that may be used to treat you if you have a stroke or other medical emergency. In case of an emergency, you or a family member should tell the doctor or emergency room staff who treat you that you are taking apixaban.

• tell your doctor if you have an artificial heart valve or if you have heavy bleeding anywhere in your body that cannot be stopped. Your doctor will probably tell you not to take apixaban.

• tell your doctor if you have or have ever had any type of bleeding problem, antiphospholipid syndrome (APS; a condition that causes blood clots), or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking apixaban, call your doctor.

• Call your doctor right away if you fall or injure yourself, especially if you hit your head. Your doctor may need to check you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• bleeding gums
• nosebleeds
• heavy vaginal bleeding
• red, pink, or brown urine
• red or black, tarry stools
• coughing up or vomiting blood or material that looks like coffee grounds
• swelling or joint pain
• headache
• rash
• chest pain or tightness
• swelling of the face or tongue
• trouble breathing
• wheezing
• feeling dizzy or faint

Apixaban prevents blood from clotting normally, so it may take longer than usual for you to stop bleeding if you are cut or injured. This medication may also cause you to bruise or bleed more easily. Call your doctor right away if bleeding or bruising is unusual, severe, or cannot be controlled.

Apixaban may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• unusual bleeding or bruising
• red, brown, or pink urine
• red or black, tarry stools
• coughing up or vomiting blood or material that looks like coffee grounds

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.