Pronunciation:

a-PIX-a-ban

Brand Names:

• Eliquis

Dosage Forms:

• Tablet

Warnings:

Premature discontinuation of apixaban or any oral anticoagulant increases the risk of thrombotic events. Consider an alternative anticoagulant if apixaban treatment is discontinued for any reason other than pathological bleeding or treatment completion. In patients undergoing neuraxial anesthesia or spinal puncture, epidural or spinal hematoma risk is increased and could result in long-term or permanent paralysis. The optimal timing between dosing apixaban and neuraxial procedures is unknown. Monitor patients for signs and symptoms of neurologic impairment and treat urgently. Consider the benefits and risks of neuraxial intervention in patients who are or need to be anticoagulated .

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Factor Xa Inhibitor

Uses of This Medicine:

Apixaban is used to treat or prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. This medicine is used for several days after hip or knee replacement surgery while you are unable to walk. It is during this time that blood clots are most likely to form.

Apixaban is also used to prevent stroke and blood clots in patients with certain heart rhythm problem (eg, nonvalvular atrial fibrillation).

Apixaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps preventing harmful clots from forming in the blood vessels.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of apixaban in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of apixaban in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide
• Levoketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Adagrasib
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amiodarone
• Amtolmetin Guacil
• Anagrelide
• Anistreplase
• Apalutamide
• Argatroban
• Aspirin
• Atazanavir
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Capmatinib
• Carbamazepine
• Celecoxib
• Ceritinib
• Choline Salicylate
• Cilostazol
• Citalopram
• Clarithromycin
• Clonixin
• Clopidogrel
• Cobicistat
• Collagenase, Clostridium histolyticum
• Conivaptan
• Curcumin
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Darunavir
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Diltiazem
• Dipyridamole
• Dipyrone
• Dronedarone
• Drotrecogin Alfa
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Enzalutamide
• Epoprostenol
• Eptifibatide
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Fosphenytoin
• Heparin
• Ibrutinib
• Ibuprofen
• Iloprost
• Indomethacin
• Inotersen
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lepirudin
• Levetiracetam
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Methotrexate
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nintedanib
• Omadacycline
• Omaveloxolone
• Orlistat
• Oxaliplatin
• Oxaprozin
• Oxcarbazepine
• Oxyphenbutazone
• Parecoxib
• Paroxetine
• Pentosan Polysulfate Sodium
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piracetam
• Piroxicam
• Posaconazole
• Pranoprofen
• Prasugrel
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Reteplase, Recombinant
• Rifampin
• Ritonavir
• Rivaroxaban
• Rofecoxib
• Sarecycline
• Selexipag
• Sertraline
• Sibutramine
• Simeprevir
• St John's Wort
• Streptokinase
• Sulfinpyrazone
• Sulindac
• Telaprevir
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trazodone
• Treprostinil
• Turmeric
• Urokinase
• Valdecoxib
• Valproic Acid
• Venlafaxine
• Verapamil
• Vilazodone
• Vorapaxar
• Voriconazole
• Vortioxetine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Antiphospholipid syndrome or
• Bleeding problems, history of or
• Catheter insertion in the spine or
• Liver disease, mild to moderate or
• Surgery (eg, spine), recent or history of—Use with caution. The risk of bleeding may be increased.

• Bleeding, active or
• Liver disease, severe or
• Prosthetic (artificial) heart valve—Should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor if you have any questions.

If you are not able to swallow whole tablets, the tablets may be crushed, mixed in D5W, water, apple juice, or applesauce. Or, the crushed tablets may be mixed with 60 mL of water or D5W dose and given through a nasogastric tube (NGT).

If you are taking another medicine to thin the blood (eg, heparin, warfarin, Coumadin®, Jantoven®), your doctor will give you very specific instructions about how to switch to apixaban. Carefully follow the instructions and ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prevention of deep venous thrombosis (hip replacement surgery):
    • Adults—2.5 milligrams (mg) two times a day, for 35 days. The first dose should be taken 12 to 24 hours after surgery.
    • Children—Use and dose must be determined by your doctor.
  • For prevention deep venous thrombosis (knee replacement surgery):
    • Adults—2.5 milligrams (mg) two times a day, for 12 days. The first dose should be taken 12 to 24 hours after surgery.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of reoccurring deep venous thrombosis and pulmonary embolism:
    • Adults—2.5 milligrams (mg) two times a day, after at least 6 months of treatment for deep venous thrombosis or pulmonary embolism.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of strokes and blood clots in patients with nonvalvular atrial fibrillation:
    • Adults—5 milligrams (mg) two times a day.
    • Adults with 2 of the following characteristics: 80 years of age and older, body weight of 60 kilograms (kg) or less, or kidney problems—2.5 mg two times a day.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of deep venous thrombosis and pulmonary embolism:
    • Adults—At first, 10 milligrams (mg) two times a day, for the first 7 days. Then, your doctor may give you 5 mg two times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine for several days before having surgery, including dental procedures.

Do not suddenly stop using this medicine without asking your doctor. You might have a higher risk of stroke after you stop using this medicine.

You may bleed and bruise more easily while you are using this medicine. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

This medicine may increase risk of blood clot in the spine or epidural area, which may lead to long-term or permanent paralysis. This is more likely to occur if you have an epidural catheter placed in your back, are taking NSAID or blood clotting medicine, a history of repeated epidural punctures or problems with your spine, or have had surgery on your spine. Tell your doctor right away if you have tingling, numbness, or muscle weakness, especially in your legs and feet.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Blood in the eyes

blood in the urine

bloody or black, tarry stools

bruising or purple areas on the skin

confusion

constipation

coughing up blood

decreased alertness

difficulty swallowing

dizziness

fainting

fast heartbeat

headache

hives, itching, skin rash

joint pain or swelling

nausea and vomiting

nosebleeds

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the eye

severe stomach pain

shortness of breath

tightness in the chest

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.