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APIXABAN
APIXABAN is a Factor Xa Inhibitor [EPC] drug. It is currently FDA-approved (first approved 2011).
At a glance
| Generic name | APIXABAN |
|---|---|
| Drug class | Factor Xa Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2011 |
Approved indications
Boxed warnings
- BOXED WARNING WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including apixaban, increases the risk of thrombotic events. If anticoagulation with apixaban 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 apixaban 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 apixaban 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 APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including apixaban, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if apixaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy. ( 2.4 , 5.1 , 14.1 ) (B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with apixaban 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. ( 5.3 )
Common side effects
- Major Bleeding
- Gastrointestinal Bleeding
- Intracranial Hemorrhage
- Hemorrhagic Stroke
- Other Intracranial Hemorrhage
Serious adverse events
- Fatal Bleeding
- Fatal Intracranial Hemorrhage
- Fatal Non-intracranial Bleeding
- Hypersensitivity Reactions
- Anaphylactic Reactions
- Syncope
Key clinical trials
- Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure (PHASE4)
- FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) (NA)
- Apixaban in Subjects With Peritoneal Dialysis (PHASE1)
- Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD (NA)
- Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers (PHASE3)
- PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years (PHASE3)
- Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS (NA)
- AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- APIXABAN CI brief — competitive landscape report
- APIXABAN updates RSS · CI watch RSS
Frequently asked questions about APIXABAN
What is APIXABAN?
APIXABAN is a Factor Xa Inhibitor [EPC] drug.
What drug class is APIXABAN in?
APIXABAN belongs to the Factor Xa Inhibitor [EPC] class. See all Factor Xa Inhibitor [EPC] drugs at /class/factor-xa-inhibitor-epc.
When was APIXABAN approved?
APIXABAN was first approved on 2011.
What development phase is APIXABAN in?
APIXABAN is FDA-approved (marketed).
What are the side effects of APIXABAN?
Common side effects of APIXABAN include Major Bleeding, Gastrointestinal Bleeding, Intracranial Hemorrhage, Hemorrhagic Stroke, Other Intracranial Hemorrhage. Serious adverse events: Fatal Bleeding, Fatal Intracranial Hemorrhage, Fatal Non-intracranial Bleeding, Hypersensitivity Reactions.
Related
- Drug class: All Factor Xa Inhibitor [EPC] drugs
- Compare: APIXABAN vs similar drugs
- Pricing: APIXABAN cost, discount & access