Eliquis (Apixaban) is an anticoagulant which works by blocking Factor Xam a key enzyme in blood clotting process, and decreasing the clotting ability of blood and preventing harmful clots from forming in the blood vessel.

It is prescribed for the prevention of blood clots due to irregular heartbeat (atrial fibrillation) or after a hip/knee replacement surgery, when a patient is still unable to walk, to prevent the formation of blood clots. Atrial fibrillation can cause blood to clot because a part of the heart is not pumping blood the way that it should. When tiny blood clots form, it can travel to different parts of the body and block vital organs, such as the brain and increase the risk for stroke or travel to the lungs and cause pulmonary embolism.

It is also prescribed after a hip/knee replacement surgery to prevent deep vein thrombosis (DVT), where blood coagulates in veins deep in the body. These tiny blood clots can travel to the heart and lungs and block the arteries causing pulmonary embolism or PE.

Prescription Name and Overview

The US Food and Drug Administration has approved Eliquis (Apixaban) for treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and to decrease the risk of abnormal blood clot formation.  It may be prescribed for continuous use to prevent clots from forming again. 

This medication may be prescribed for other uses. Consult a medical professional for more information.

Eliquis (Apixaban) is available only with a doctor’s prescription. It is administered in tablet form  in strengths of 2.5 mg and 5mg and may be taken by mouth with or without food exactly as directed by your doctor.

Generic Name and Overview

Apixaban is used to help prevent strokes or abnormal formation of blood clots in people who have atrial fibrillation, to prevent DVT (a blood clot usually in the leg), and pulmonary embolism in people who have undergone hip/knee replacement surgery. Apixaban belongs to a class of medications called factor Xa inhibitors and works by blocking the action of natural substances that help blood clots to form.

FDA has granted market exclusivity for Bristol-Myers Squibb Company, preventing the generic forms and alternatives of Eliquis from being manufactured and distributed in the market. This market exclusivity has expired on December 24, 2017 but another patent will not expire till 2023. There was a generic alternative that was supposedly scheduled to be released by 2018, but as of now FDA has not released any statement about this yet.  

OTC  Name and Overview

         Manufacturer

Eliquis is manufactured by Bristol-Myers Squibb Company from Princeton, New Jersey 08548 USA and marketed by Pfizer, Inc from New York, New York 10017 USA. The FDA approved the manufacture and marketing of Eliquis on December 2012.

         Labeled Indications

•   Reduces the risk of stroke and blood clots in people who have atrial fibrillation
•   Reduces the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery
•   Treats blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), and reduce the risk of them occurring again.

         Active Ingredients

         The active ingredient of Eliquis is apixaban.

What Is It Used For?

 Eliquis (Apixaban) is used to help prevent stroke and treat blood clots in people who have atrial fibrillation, DVT, angina, and pulmonary embolism in people who have undergone hip/knee replacement surgery. 

         How Does it Work?

 Apixaban belongs to a class of medications called factor Xa inhibitors and works by blocking the action of natural substances that help blood to clot.

         What are the Approved Uses?

Eliquis (Apixaban) comes in 2.5 mg and 5 mg tablets that are administered orally.

• For patients with atrial fibrillation, it is usually prescribed in 5mg tablets, taken twice a day. For older patients who are 80 years and older, patients who weigh 132 pounds or less, and patients with 1.5 mg/dL or greater creatinine level, a smaller dose of 2.5 mg x 2/day  is prescribed.
• For patients who have undergone hip/knee replacement surgery, Eliquis is prescribed to prevent DVT 12 to 24 hours right after the surgery. Patients are given 2.5 mg doses twice a day to prevent the blood from clotting deep within the veins, and will continue this dosage to about 12 to 35 days depending on the situation.
• For patients who have suffered DVT or PE, a dosage of 10 mg twice a day is given to prevent the DVT or PE from recurring. It is up to the doctor to decrease the dosage. 
• For treatment of DVT or PE, patients may be instructed by the doctor to continue the medication in lesser dosages to reduce the risk of the recurrence of abnormal blood clots.

         Production Anecdotes / History

Eliquis was first approved for use in Europe on December 28, 2012, and then in the US in 2014 under the Bristol-Myers Squibb Company and Pfizer Inc.

THe drug has been highly anticipated by cardiologists, as some experts have argued that Eliquis offers the best balance between benefits and risks. It is the third anti clotting medicine to be approved in recent years, right after Pradaxa (sold by Boehringer Ingelheim), and Zarelto (sold by Johnson & Johnson and Bayer).

An article published by the New England Journal of Medicine in 2011 concluded that apixaban caused lesser bleeding and lower death rates, making it more effective to warfarin. The trial was conducted by Bristol-Myers Squibb and was called ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrilation). However, the FDA soon found out that the results may not be reliable because the placebo and the drugs may have been switched during the study. 

Precautions

 Before taking Eliquis (apixaban),:

1.  Inform your doctor or your pharmacist of all your allergies or if you have had even a slight allergic reaction to apixaban. Eliquis contains other inactive ingredients and you may have an allergic reaction to it. 
2. Inform your doctor about your medical history especially if you have:
   1. A prosthetic heart valve
   2. Liver disease
   3. Kidney disease
   4. Blood disorders (anemia, thrombocytopenia, hemophilia)
   5. History of bleeding (stomach/intestinal bleeding, bleeding in the brain, etc)
   6. Recent surgery
   7. Stroke
   8. Injury 

While taking Eliquis (apixaban)

1. Alcohol may trigger stomach bleeding if consumed with Eliquis. The drug may increase your risk of stomach bleeding, so it is best to limit or abstain from alcoholic beverages. Consult your doctor or any medical professional if you wish to consume alcoholic drinks to know how much alcohol is safe for you to drink. 
2. Before going through any minor or major surgery or dental procedures, tell your doctor or dentist that you are taking this drug. You might be asked to stop taking Eliquis or given an alternative medicine before your surgery. Ask specifically about starting and stopping instructions.
3. Eliquis may cause bleeding because it lowers your blood’s clotting ability. Always exercise caution when using objects like razors, nail cutters, razors, and toothbrushes. Avoid rigorous physical activities such as contact sports. If you experience a fall, an injury, or hit your head, call your doctor right away.

If you want to stop taking Eliquis (apixaban)

1. Don’t stop taking Eliquis on your own without your doctor prescribing you an alternate medication. Discontinuing apixaban increases a patient’s risk of thrombotic events. An increased rate of stroke was seen in atrial fibrillation trials when patients were transitioned from apixaban to warfarin.
2. If you are pregnant, are trying to get pregnant, or are breastfeeding, discuss the risks and benefits with your doctor. 

Long-Term Use Considerations

 Abruptly stopping the use of apixaban without an alternative medication increases a patient’s risk of stroke and other thrombotic events.

Eliquis increases the risk of bleeding and may cause serious and even fatal bleeding. This could mean that you will have your blood checked all throughout the time you’re taking the drug. Your doctor will need to check your “prothrombin time” or the time it takes for your blood to clot. 

Drug Interactions

Drug interactions happen when a substance that you are taking changes or disrupts the way how a medication works. Interactions may be harmful to you and increase your risk for serious side effects, or inhibit a drug from functioning properly. Always consult your doctor if you are going to start medication with a new drug.

         Can Interact with the Following

Eliquis can negatively interact with:

• Mifepristone or other drugs that can cause bleeding and bruising
• Warfarin, enoxaparin and other blood “thinners”
• Selective serotonin reuptake inhibitors (SSRIs) like Celexa, Prozac, Luvox, Zoloft, Brisdelle, Paxil, or Pexeva
• Serotonin and norepinephrine reuptake inhibitors (SNRIs) like Cymbalta, Khedezla or Pristiq, Fetzima or Savella, or Effexor
• Azole antifungals (like itraconazole, ketoconazole, posaconazole)
• Conivaptan
• HIV protease inhibitors (like lopinavir, ritonavir)
• Rifamycins (like rifabutin)
• St. John’s wort
• Seizure treatment drugs (like carbamazepine, phenytoin)

This is not an exhaustive list. Always ask your doctor or pharmacist if you are going to take other medicines together with Eliquis.

         Can’t Interact with the Following

Other prescription and nonprescription medicines such as aspirin, NSAIDs, ibuprofen, and naproxen may increase your risk of bleeding if taken with Eliquis.

When To Stop Taking

Don’t suddenly stop using this medicine without first talking to your doctor. Continue to take Eliquis even if you feel well, and don’t miss any doses. If you need to stop using Eliquis, your healthcare provider may prescribe another blood thinner to help prevent stroke.

Eliquis may need to be stopped before you undergo a surgery or a medical or dental procedure.

Long-Term Side Effects

When you stop taking Eliquis, you may have increased risk of forming a blood clot and suffer a stroke. Always ask your doctor if you want to stop taking it. Eliquis contains a black box warning because it may cause a higher risk of stroke when people with atrial fibrillation stop taking it.

FDA Warnings (History Of)

Eliquis has a black box warning from the US FDA. Medscape lists them as follows:
Discontinuing in patients with nonvalvular atrial fibrillation

• Premature discontinuation of any oral anticoagulant, including, apixaban, increases risk of thrombotic events; consider using another anticoagulant if anticoagulation with apixaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy
• 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 (see Dosing Considerations)

Spinal/epidural hematoma

• Increased risk of epidural or spinal hematoma when used with neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture (can result in long-term or permanent paralysis)
• Risk increased with indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis (eg, NSAIDs, platelet aggregation inhibitors, other anticoagulants)
• Risk also increased by traumatic or repeated epidural or spinal puncture; if this occurs, delay apixaban administration for 48 hr
• Monitor patients for signs and symptoms of neurologic impairment; if neurologic compromise is noted, urgent treatment is necessary
• Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hr after the last administration of apixaban; the next apixaban dose should not be administered earlier than 5 hr after the removal of the catheter
• Consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

Other Common Side Effects

Call your doctor right away if you experience allergic reactions, serious bleeding or if you experience vision changes, confulsion, slurred speech, weakness of one side of the body. 

Other side effects of the drug are:

• Easy bruising
• Unusual bleeding or bleeding that won’t stop, including nosebleeds and bleeding gums
• Heavy menstrual periods
• Pink, brown, or red urine
• Black or bloody stools
• Coughing up blood, or vomit that looks like coffee grounds
• Trouble breathing or wheezing
• Severe headache
• Dizziness or feeling like you might pass out
• Severe weakness
• Rash
• Swelling or joint pain
• Chest pain or tightness
• Signs of anaphylaxis, which may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat

Lawsuits

Pfizer, Inc., Bristol-Myers Squibb Company, and McKesson Corporation are all facing an Eliquis group lawsuit filed by plaintiffs because of alleged injuries suffered after taking Eliquis. One plaintiff has filed a case on behalf of the deceased mother, claiming that she suffered severe bleeding due to the drug’s side effects.

Another person has filed a lawsuit claiming that her husband died of gastrointestinal bleeding complications due to bleeding from Eliquis. Another person has claimed that the drug caused bleeding in his urine and stool, worsening his condition to the point where he suffered a stroke.

There had been at least 3,000 lawsuits filed against Eliquis in federal courts throughout the US.