Apixaban

Apixaban is a prescription medication used to reduce the risk of stroke and systemic embolism (artery blockage). Apixaban belongs to a group of drugs called Xa inhibitor anticoagulants, which decrease the chance of a blood clot forming in the body. It is also used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in some patients as well as prevent blood clots that travel throughout the body in patients who have been treated for these type of blood clots.

This medication comes in tablet form and is taken twice a day with or without food.

Common side effects are related to bleeding.

Apixaban 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 deep vein thrombosis (DVT) and pulmonary embolism (PE) in some patients.
• prevent DVT and PE from happening again in those patients who have been treated for a (DVT) or (PE). 

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

Apixaban may be found in some form under the following brand names:

• Eliquis

Serious side effects have been reported with apixaban. See “Drug Precautions” section.

Apixiban 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. 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.

You may have a higher risk of bleeding if you take apixaban 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.

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

• 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 lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking apixaban, you may have increased risk of forming a clot in your blood.
  • Do not stop taking apixaban without talking to the doctor who prescribes it for you. Stopping apixaban increases your risk of having a stroke.
  • Apixaban may need to be stopped, if possible, prior to surgery or a medical or dental procedure. Ask the doctor who prescribed apixaban for you when you should stop taking it. Your doctor will tell you when you may start taking apixaban again after your surgery or procedure. If you have to stop taking apixaban, your doctor may prescribe another medicine to help prevent a blood clot from forming.

• Apixaban can cause bleeding which can be serious and rarely may lead to death. This is because apixaban is a blood thinner medicine that reduces blood clotting.
  
  While taking apixaban:
  
  Call your doctor or get medical help right away if you have any of these signs or symptoms of bleeding when taking apixaban:
  • you may bruise more easily
  • it may take longer than usual for any bleeding to stop
  • 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 is not for patients with artificial heart valves.

Serious side effects of apixaban may include the following:

• Apixaban 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. For more information, ask your doctor or pharmacist.

Do not take apixaban if you:

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of apixaban, there are no specific foods that you must exclude from your diet when receiving apixaban.

Before you take apixaban, tell your doctor if you:

• have kidney or liver problems
• have any other medical condition
• have ever had bleeding problems
• will be having any surgery or procedure done in the future
• are pregnant or plan to become pregnant. It is not known if apixaban will harm your unborn baby.
• 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 or breastfeed. You should not do both.

Tell all of your doctors and dentists that you are taking apixaban. They should talk to the doctor who prescribed apixaban 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 works. Certain medicines may increase your risk of bleeding or stroke when taken with apixaban.

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Apixaban falls into category B. There are no good studies of apixaban in pregnant women. Treatment is likely to increase the risk of bleeding during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is unknown whether apixaban or its metabolites are excreted in human milk.

Women should be instructed either to stop breastfeeding or to stop apixaban therapy, taking into account the importance of the drug to the mother.

• Take apixaban exactly as prescribed by your doctor.
• Take apixaban twice every day with or without food.
• Do not change your dose or stop taking apixaban unless your doctor tells you to.
• If you miss a dose of apixaban, take it as soon as you remember. Do not take more than one dose of apixaban at the same time to make up for a missed dose.
• Your doctor will decide how long you should take apixaban. Do not stop taking it without first talking with your doctor. Stopping apixaban may increase your risk of having a stroke.
• Do not run out of apixaban. Refill your prescription before you run out.
• If you take too much apixaban, 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.
• Apixaban should be stopped at least 48 hours prior to surgery or procedures with a moderate or high risk of significant bleeding. Tell your doctor about any upcoming surgery or procedure before stopping this medication.
  • Apixaban should be stopped at least 24 hours before to surgery or procedures with a low risk of bleeding or where the bleeding would be non-critical and easily controlled. Tell your doctor about any upcoming surgery or procedure before stopping this medication.

The recommended dose of Eliquis (apixaban) for reducing the risk of stroke and blood clots in patients with atrial fibrillation is 5 mg taken orally twice daily. 

The recommended dose of Eliquis (apixaban) for preventing clots after hip or knee replacement surgery is 2.5 mg orally twice daily.

The recommended dose of Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily.

The recommended dose of Eliquis (apixaban) for reducing the risk of having another DVT and PE after being treated for these type of blood clots is 2.5 mg taken orally twice daily. 

Dose changes may be made according to your age, body weight, kidney function, and if you are taking other medications that may interact with apixaban.

If you take too much apixaban call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If apixaban is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store apixaban 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.

WARNING: DISCONTINUING THIS MEDICATION IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE

Discontinuing apixaban places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of apixaban in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with apixaban must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered.