MEDICATION GUIDE

Apixaban (a pix’ a ban) Tablets

What is the most important information I should know about apixaban tablets?

• For people taking apixaban tablets for atrial fibrillation:
  
  People with atrial fibrillation (a type of irregular heartbeat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. Apixaban tablets lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking apixaban tablets, you may have increased risk of forming a clot in your blood.
  
  Do not stop taking apixaban tablets without talking to the doctor who prescribes it for you. Stopping apixaban tablets increases your risk of having a stroke.
  
  Apixaban tablets may need to be stopped, if possible, prior to surgery or a medical or dental procedure. Ask the doctor who prescribed apixaban tablets for you when you should stop taking it. Your doctor will tell you when you may start taking apixaban tablets again after your surgery or procedure. If you have to stop taking apixaban tablets, your doctor may prescribe another medicine to help prevent a blood clot from forming.
  
  
• Apixaban tablets can cause bleeding which can be serious and rarely may lead to death. This is because apixaban tablets are a blood thinner medicine that reduces blood clotting.
  
  You may have a higher risk of bleeding if you take apixaban tablets and take other medicines that increase your risk of bleeding, including:
  
  • aspirin or aspirin-containing products
  • long-term (chronic) use of nonsteroidal anti-inflammatory drugs (NSAIDs)
  • warfarin sodium (COUMADIN®, JANTOVEN®)
  • any medicine that contains 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. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

While taking apixaban tablets:

• 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 apixaban tablets:

• 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
• bleeding that is severe or you cannot control
• red, pink, or brown urine
• 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

• Apixaban tablets are not for patients with artificial heart valves.
• Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like apixaban tablets, 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 apixaban tablets 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.

• Apixaban tablets are not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing, who have a history of blood clots.

What are apixaban tablets?

Apixaban tablets are 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 apixaban tablets are safe and effective in children.

Who should not take apixaban tablets?

Do not take apixaban tablets if you:

• currently have certain types of abnormal bleeding.
• have had a serious allergic reaction to apixaban tablets. Ask your doctor if you are not sure.

What should I tell my doctor before taking apixaban tablets?

Before you take apixaban tablets, tell your doctor if you:

• have kidney or liver problems
• have antiphospholipid syndrome
• have any other medical condition
• have ever had bleeding problems
• are pregnant or plan to become pregnant. It is not known if apixaban tablets will harm your unborn baby.
• Females who are able to become pregnant: Talk with your healthcare provider about pregnancy planning during treatment with apixaban tablets. Talk with your healthcare provider about your risk of severe uterine bleeding if you are treated with blood thinner medicines, including apixaban tablets.
• are breastfeeding or plan to breastfeed. It is not known if apixaban passes into your breast milk. You and your doctor should decide if you will take apixaban tablets or breastfeed. You should not do both.

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

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 apixaban tablets works. Certain medicines may increase your risk of bleeding or stroke when taken with apixaban tablets. See "What is the most important information I should know about apixaban tablets?"

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take apixaban tablets?

• Take apixaban tablets exactly as prescribed by your doctor.
• Take apixaban tablets twice every day with or without food.
• Do not change your dose or stop taking apixaban tablets unless your doctor tells you to.
• If you miss a dose of apixaban tablets, take it as soon as you remember. Do not take more than one dose of apixaban tablets at the same time to make up for a missed dose.
• If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take apixaban tablets.
• Your doctor will decide how long you should take apixaban tablets. Do not stop taking it without first talking with your doctor. If you are taking apixaban tablets for atrial fibrillation, stopping apixaban tablets may increase your risk of having a stroke.
• Do not run out of apixaban tablets. Refill your prescription before you run out. When leaving the hospital following hip or knee replacement, be sure that you will have apixaban tablets available to avoid missing any doses.
• If you take too much apixaban tablets, call your doctor or go to the nearest hospital emergency room right away.
• Call your doctor or healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your doctor or healthcare provider may need to check you.

What are the possible side effects of apixaban tablets?

• See "What is the most important information I should know about apixaban tablets?"
• Apixaban tablets 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 apixaban tablets. 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.

How should I store apixaban tablets?

Store apixaban tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep apixaban and all medicines out of the reach of children.

General Information about Apixaban Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use apixaban tablets for a condition for which it was not prescribed. Do not give apixaban tablets to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about apixaban tablets that is written for health professionals.

For more information, call Impax Laboratories, Inc. at 1-800-934-6729 or go to www.impaxlabs.com.

What are the ingredients in apixaban tablets?

Active ingredient: apixaban.

Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets).

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Trademarks are the property of the respective owners.

Manufactured by:
MSN Laboratories Private Limited
Telangana 509216
India

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

1967-05

Rev. 5/2024