Generic Name: apixaban
Date of Approval: December 28, 2012
Company: Bristol-Myers Squibb Company and Pfizer Inc.
Treatment for: Prevention of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation
FDA Approves Eliquis
The U.S. Food and Drug Administration has approved the anti-clotting drug Eliquis (apixaban), an oral factor Xa inhibitor anticoagulant used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
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. Eliquis lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking Eliquis, you may have increased risk of forming a clot in your blood.
Do not stop taking this medicine without talking to the doctor who prescribes it for you. Stopping increases your risk of having a stroke.
Eliquis may need to be stopped, if possible, prior to surgery or a medical or dental procedure. Ask the doctor who prescribed it for you when you should stop taking it. Your doctor will tell you when you may start taking it again after your surgery or procedure. 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 apixaban 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, 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
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
- 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
- Eliquis is not for patients with artificial heart valves.
What is Eliquis?
Eliquis is a prescription medicine used to reduce the risk of stroke and blood clots in people who have atrial fibrillation.
It is not known if it 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.
Before taking this medicine
Before you take this medicine, 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 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 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 it 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 Eliquis works. Certain medicines may increase your risk of bleeding or stroke when taken in combination. See Important information about Eliquis.
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 Eliquis?
- Take exactly as prescribed by your doctor.
- Take twice every day with or without food.
- Do not change your dose or stop taking unless your doctor tells you to.
- If you miss a dose, take it as soon as you remember. Do not take more than one dose at the same time to make up for a missed dose.
- Your doctor will decide how long you should take Eliquis. Do not stop taking it without first talking with your doctor. Stopping may increase your risk of having a stroke.
- Do not run out of Eliquis. Refill your prescription before you run out.
- If you take too much, 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.
Eliquis side effects
- See Important information 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. 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.
See also: Eliquis side effects (in more detail)
Store at room temperature between 68°F to 77°F (20°C to 25°C).
Keep all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give this medicine 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 that is written for health professionals.
For more information, call 1-855-354-7847 (1-855-ELIQUIS) or go to www.eliquis.com.
Active ingredient: apixaban.
Inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets).