ELIQUIS
Eliquis (apixaban) is a Factor Xa inhibitor indicated for the prevention and treatment of various blood clotting disorders. It is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The drug is also prescribed for the prophylaxis of deep vein thrombosis (DVT) in patients following hip or knee replacement surgery. Furthermore, it is approved for the treatment of DVT and pulmonary embolism (PE), and to reduce the risk of recurrence for both conditions.
How ELIQUIS Works
Apixaban acts as a selective inhibitor of Factor Xa (FXa), an enzyme necessary for the formation of blood clots. By inhibiting free and clot-bound FXa and prothrombinase activity, the medication decreases thrombin generation and subsequent thrombus development. Although it does not directly affect platelet aggregation, it indirectly inhibits this process by reducing thrombin levels. This antithrombotic activity is achieved without the requirement of antithrombin III.
Details
- Status
- Prescription
- First Approved
- 2012-12-28
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET, TABLET, FOR SUSPENSION
ELIQUIS Approval History
What ELIQUIS Treats
4 indicationsELIQUIS is approved for 4 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Stroke Prevention
- Atrial Fibrillation
- Deep Vein Thrombosis
- Pulmonary Embolism
ELIQUIS Boxed Warning
(A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Adm...
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) , and Clinical Studies (14.1) ] . (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of ELIQUIS and neuraxial procedures is not known [see Warnings and Precautions (5.3) ] Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3) ] . Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.3) ] . WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREAS
ELIQUIS Target & Pathway
ProTarget
The central enzyme in blood coagulation that converts fibrinogen to fibrin, forming blood clots. Direct thrombin inhibitors prevent clot formation and are used to prevent stroke and treat blood clots.
ELIQUIS Competitors
Pro6 other drugs also target THROMBIN. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (THROMBIN). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to ELIQUIS
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ELIQUIS FDA Label Details
ProIndications & Usage
FDA Label (PDF)ELIQUIS is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with n...
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thromb...
ELIQUIS Patents & Exclusivity
Patents (87 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.