Apixaban

What is Apixaban?

• Apixaban (Eliquis) is a factor Xa inhibitor used to decrease the risk of venous thromboses, systemic embolization and stroke in patients with atrial fibrillation, and lower the risk of deep vein thrombosis and pulmonary embolus after knee or hip replacement surgery.

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Apixaban

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Apixaban binding

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Apixaban ball-and-stick model

What are the uses of this medicine?

Apixaban Eliquis 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 blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), and reduce the risk of them occurring again.

How does this medicine work?

• Apixaban (a pix' a ban) is a direct and reversible inhibitor of factor Xa (-xaban), the rate controlling last step in the generation of thrombin, the final intermediate in blood coagulation.
• Inhibiting thrombin prevents the conversion of fibrinogen to fibrin and subsequent cross linking of fibrin monomers, platelet activation and amplification of coagulation.
• Apixaban has been shown to be as effective as warfarin and more effective than aspirin in preventing stroke and systemic embolization in patients with atrial fibrillation.
• Clinical trials have also shown that apixaban therapy can decrease the risk of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• currently have certain types of abnormal bleeding.
• have had a serious allergic reaction to Eliquis.

What drug interactions can this medicine cause?

• Combined P-gp and strong CYP3A4 inhibitors increase blood levels of apixaban. Reduce Eliquis dose or avoid coadministration.
• Simultaneous use of combined P-gp and strong CYP3A4 inducers reduces blood levels of apixaban. Avoid concomitant use of Eliquis with combined P-gp and strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort).
• Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with Eliquis.
• Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding.

Is this medicine FDA approved?

• Apixaban was approved for use in the United States in 2012.
• Current indications are for prevention of stoke and systemic embolism in patients with nonvalvular atrial fibrillation, prevention of deep vein thrombosis after hip or knee replacement surgery, treatment of deep vein thrombosis and pulmonary embolism, and reduction in risk of recurrence of deep vein thrombosis or pulmonary embolism.

How should this medicine be used?

Recommended dosage: Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation:

• The recommended dose is 5 mg orally twice daily.

In patients with at least 2 of the following characteristics:

• age greater than or equal to 80 years, body weight less than or equal to 60 kg, or serum creatinine greater than or equal to 1.5 mg/dL, the recommended dose is 2.5 mg orally twice daily.

Prophylaxis of DVT following hip or knee replacement surgery:

• The recommended dose is 2.5 mg orally twice daily.

Treatment of DVT and PE:

• The recommended dose is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily.

Reduction in the risk of recurrent DVT and PE following initial therapy:

• The recommended dose is 2.5 mg taken orally twice daily.

Administration:

• Take Eliquis twice every day with or without food.
• Do not change your dose or stop taking Eliquis unless your doctor tells you to.
• If you miss a dose of Eliquis, take it as soon as you remember. Do not take more than one dose of Eliquis 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 Eliquis.
• Your doctor will decide how long you should take Eliquis. Do not stop taking it without first talking with your doctor. If you are taking Eliquis for atrial fibrillation, stopping Eliquis may increase your risk of having a stroke.
• Do not run out of Eliquis. Refill your prescription before you run out. When leaving the hospital following hip or knee replacement, be sure that you will have Eliquis available to avoid missing any doses.
• If you take too much Eliquis, 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 2.5 mg and 5 mg

This medicine is available in fallowing brand namesː

• Eliquis

What side effects can this medication cause?

The most common side effects of this medicine include:

• The most common side effects of this medicine are related to bleeding.
• Eliquis can cause a skin rash or severe allergic reaction.
• Spinal or epidural blood clots (hematoma)

What special precautions should I follow?

• Eliquis can cause serious, potentially fatal, bleeding. Promptly evaluate signs and symptoms of blood loss. An agent to reverse the anti-factor Xa activity of apixaban is available.
• Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs).
• Premature discontinuation of any oral anticoagulant, including Eliquis, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events.
• When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, or bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary.
• The safety and efficacy of Eliquis have not been studied in patients with prosthetic heart valves. Therefore, use of Eliquis is not recommended in these patients.
• Direct-acting oral anticoagulants (DOACs), including Eliquis, are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS).

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Overdose of Eliquis increases the risk of bleeding.

Treatment of overdosage:

• Administration of activated charcoal may be useful in the management of Eliquis overdose or accidental ingestion.
• An agent to reverse the anti-factor Xa activity of apixaban is available.

Can this medicine be used in pregnancy?

• The limited available data on Eliquis use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes.
• Treatment may increase the risk of bleeding during pregnancy and delivery.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• 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).

Who manufactures and distributes this medicine?

• Marketed by:

Bristol-Myers Squibb Company Princeton, New Jersey USA and Pfizer Inc New York, New York USA

What should I know about storage and disposal of this medication?

• Store Eliquis at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Eliquis and all medicines out of the reach of children.

• Dailymed label info on Apixaban
• FDA Apixaban

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